Trial Outcomes & Findings for Chronic Hypertension and Pregnancy (CHAP) Project (NCT NCT02299414)

NCT ID: NCT02299414

Last Updated: 2023-05-17

Results Overview

One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB \<35 weeks (not due to spontaneous preterm labor or membrane rupture).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 2408 participants
• Primary outcome timeframe: Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death
• Results posted on: 2023-05-17

Participant Flow

Participant milestones

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Overall Study STARTED	1208	1200
Overall Study COMPLETED	1208	1200
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data regarding body-mass index were missing for 19 in the active group and 22 in the control group.

Baseline characteristics by cohort

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.	Total n=2408 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 5.6 • n=1208 Participants	32.3 years STANDARD_DEVIATION 5.8 • n=1200 Participants	32.3 years STANDARD_DEVIATION 5.7 • n=2408 Participants
Sex: Female, Male Female	1208 Participants n=1208 Participants	1200 Participants n=1200 Participants	2408 Participants n=2408 Participants
Sex: Female, Male Male	0 Participants n=1208 Participants	0 Participants n=1200 Participants	0 Participants n=2408 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Non-Hispanic White	347 Participants n=1208 Participants	326 Participants n=1200 Participants	673 Participants n=2408 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Non-Hispanic Black	574 Participants n=1208 Participants	570 Participants n=1200 Participants	1144 Participants n=2408 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Hispanic	238 Participants n=1208 Participants	250 Participants n=1200 Participants	488 Participants n=2408 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Other	49 Participants n=1208 Participants	54 Participants n=1200 Participants	103 Participants n=2408 Participants
Region of Enrollment United States	1208 participants n=1208 Participants	1200 participants n=1200 Participants	2408 participants n=2408 Participants
Insurance Type Government-assisted or Medicaid	673 Participants n=1208 Participants	656 Participants n=1200 Participants	1329 Participants n=2408 Participants
Insurance Type Private	459 Participants n=1208 Participants	463 Participants n=1200 Participants	922 Participants n=2408 Participants
Insurance Type None	60 Participants n=1208 Participants	65 Participants n=1200 Participants	125 Participants n=2408 Participants
Insurance Type Missing data	16 Participants n=1208 Participants	16 Participants n=1200 Participants	32 Participants n=2408 Participants
Type of CHTN Newly diagnosed	263 Participants n=1208 Participants	258 Participants n=1200 Participants	521 Participants n=2408 Participants
Type of CHTN Diagnosed and receiving medication	677 Participants n=1208 Participants	681 Participants n=1200 Participants	1358 Participants n=2408 Participants
Type of CHTN Diagnosed and not receiving medication	268 Participants n=1208 Participants	261 Participants n=1200 Participants	529 Participants n=2408 Participants
Blood Pressure - Systolic	134.3 mmHg STANDARD_DEVIATION 12.7 • n=1208 Participants	133.7 mmHg STANDARD_DEVIATION 12.4 • n=1200 Participants	134.0 mmHg STANDARD_DEVIATION 12.6 • n=2408 Participants
Blood Pressure - Diastolic	83.9 mmHg STANDARD_DEVIATION 9.5 • n=1208 Participants	83.4 mmHg STANDARD_DEVIATION 9.6 • n=1200 Participants	83.7 mmHg STANDARD_DEVIATION 9.6 • n=2408 Participants
Prior Pregnancy	1007 Participants n=1208 Participants	989 Participants n=1200 Participants	1996 Participants n=2408 Participants
BMI	37.7 kg/m^2 STANDARD_DEVIATION 10.0 • n=1189 Participants • Data regarding body-mass index were missing for 19 in the active group and 22 in the control group.	37.5 kg/m^2 STANDARD_DEVIATION 9.6 • n=1178 Participants • Data regarding body-mass index were missing for 19 in the active group and 22 in the control group.	37.6 kg/m^2 STANDARD_DEVIATION 9.8 • n=2367 Participants • Data regarding body-mass index were missing for 19 in the active group and 22 in the control group.
Gestational Age less than 14 weeks	496 Participants n=1208 Participants	481 Participants n=1200 Participants	977 Participants n=2408 Participants
Diabetes Mellitus	191 Participants n=1208 Participants	189 Participants n=1200 Participants	380 Participants n=2408 Participants
Current Smoker	92 Participants n=1208 Participants	82 Participants n=1200 Participants	174 Participants n=2408 Participants
Aspirin Use	539 Participants n=1208 Participants	536 Participants n=1200 Participants	1075 Participants n=2408 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death

One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB <35 weeks (not due to spontaneous preterm labor or membrane rupture).

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1170 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1155 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Composite Adverse Perinatal Outcome Composite Primary Outcome	353 Participants	427 Participants
Composite Adverse Perinatal Outcome Preeclampsia with Severe Features	272 Participants	336 Participants
Composite Adverse Perinatal Outcome Indicated Preterm Birth <35 weeks	143 Participants	193 Participants
Composite Adverse Perinatal Outcome Placental Abruption	20 Participants	22 Participants
Composite Adverse Perinatal Outcome Fetal or Neonatal Death <28 days	41 Participants	50 Participants

PRIMARY outcome

Timeframe: Until delivery

Population: Analysis is restricted to 2270 (1146 in the Treatment Group and 1124 in the Standard Group) who were delivered and who had complete assessments during delivery.

Birth weight less than 10th percentile for gestational age at birth according to accepted national standard

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1146 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1124 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Small for Gestational Age (Safety)	128 Participants	117 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks (4-12 weeks) after delivery

One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Composite of Maternal Death or Severe Cardiovascular Morbidity	25 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 2 weeks postpartum or 90 days for neonatal death

Persistent severe hypertension with or without proteinuria + the primary composite

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Severe Maternal Hypertension + Components of the Primary Composite Endpoint	529 Participants	631 Participants

SECONDARY outcome

Timeframe: Until delivery

Preterm birth and Indicated preterm birth (<37 weeks) includes any preterm birth less than 37 weeks

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Preterm Birth and Indicated Preterm Birth (<37 Weeks)	332 Participants	377 Participants

SECONDARY outcome

Timeframe: Up to 90 days post delivery

One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Composite of Severe Neonatal Morbidities	24 Participants	31 Participants

SECONDARY outcome

Timeframe: 6 weeks (4-12 weeks) after delivery

Population: Analysis is restricted to 706 in Treatment Group and 479 in Standard Group who had complete antihypertensive therapy assessments at the follow-up study visit.

Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications.

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=706 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=479 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Adherence to Treatment After Delivery	436 Participants	275 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 weeks after delivery

Mild or severe, including eclampsia

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Superimposed Preeclampsia	295 Participants	373 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment (between 6 and 18 weeks gestation) to delivery

Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Superimposed Gestational Hypertension	132 Participants	156 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks (4-12 weeks) after delivery

Blood pressure ≥160/110

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Severe Hypertension	436 Participants	531 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Until delivery

Cesarean delivery

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Cesarean Delivery	592 Participants	582 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks

During pregnancy or postpartum

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Blood Transfusion	46 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks (4-12 weeks) after delivery

Any NICU admission

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
NICU Admission	368 Participants	402 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At birth

Birth weight <2500g

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Low Birth Weight	232 Participants	277 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At birth

Population: data incomplete for 71 in the Treated Group and 83 in the Standard Group

Mean ponderal index, mass/height^3 at birth

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1137 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1117 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Ponderal Index	2.9 g/cm^3 Standard Deviation 3.7	2.7 g/cm^3 Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: At birth

Population: data incomplete for 84 in the Treated Group and 97 in the Standard Group

Mean head circumference

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1124 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1103 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Head Circumference	33.3 cm Standard Deviation 3.0	33.0 cm Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery

Population: data incomplete for 549 in the Treated Group and 562 in the Standard Group

Mean placental weight

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=659 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=638 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Placental Weight	466.3 g Standard Deviation 177.6	464.6 g Standard Deviation 175.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Prevalence of hypoglycemia

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Hypoglycemia	191 Participants	195 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Prevalence of bradycardia

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Bradycardia	31 Participants	35 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with hypotension

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Hypotension	7 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with respiratory distress syndrome (RDS)

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Respiratory Distress Syndrome (RDS)	149 Participants	171 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months after delivery

Incidence (%) with bronchopulmonary dysplasia (BPD)

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Bronchopulmonary Dysplasia (BPD)	8 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Intubation/Ventilation	298 Participants	303 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with any IVH and with IVH Grades III and IV

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Intraventricular Hemorrhage (IVH)	11 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months after delivery

Incidence (%) with necrotizing enterocolitis (NEC)

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Necrotizing Enterocolitis (NEC)	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with hyperbilirubinemia

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Hyperbilirubinemia	266 Participants	283 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery

Incidence (%) with Apgar score <7 (range 0-10 with lower scores indicating worse outcome)

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
5-min Apgar Score	68 Participants	80 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From delivery to hospital discharge (2 - 3 days after delivery)

Incidence (%) with proven sepsis

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Sepsis	21 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months after delivery

Number of unscheduled clinic or ER visits before and after delivery

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Unscheduled Prenatal Clinic or ER Visits	1.1 number of encounters Standard Deviation 1.6	1.2 number of encounters Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months postpartum

Number of hospitalizations before or after delivery

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Hospitalizations	0.3 number of encounters Standard Deviation 0.7	0.3 number of encounters Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months after delivery

Number of postpartum unscheduled or ER visits

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Postpartum Unscheduled or ER Visits	0.3 number of encounters Standard Deviation 0.8	0.4 number of encounters Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months after delivery

Number of postpartum hospitalizations

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Postpartum Hospitalizations	0.15 number of encounters Standard Deviation 0.44	0.14 number of encounters Standard Deviation 0.37

OTHER_PRE_SPECIFIED outcome

Timeframe: after delivery

Frequency of neonatal hospital stays lasting at least 3 days

Outcome measures

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 Participants Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 Participants Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Neonatal Hospital Stay of 3 or More Days	590 Participants	592 Participants

Adverse Events

Anti-hypertensive Therapy to Goal <140/90 mmHg

Serious events: 113 serious events

Other events: 0 other events

Deaths: 42 deaths

No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg

Serious events: 126 serious events

Other events: 0 other events

Deaths: 52 deaths

Serious adverse events

Measure	Anti-hypertensive Therapy to Goal <140/90 mmHg n=1208 participants at risk Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)	No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg n=1200 participants at risk Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Respiratory, thoracic and mediastinal disorders Asthma	0.25% 3/1208 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Blood and lymphatic system disorders Anaemia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Blood and lymphatic system disorders Foetal anaemia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Foetal Death	3.0% 36/1208 • Number of events 36 • Adverse event data collected up to 2 week postpartum visit.	3.5% 42/1200 • Number of events 42 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Foetal Growth Restriction	0.25% 3/1208 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Preeclampsia	0.83% 10/1208 • Number of events 10 • Adverse event data collected up to 2 week postpartum visit.	2.0% 24/1200 • Number of events 24 • Adverse event data collected up to 2 week postpartum visit.
General disorders Death Neonatal	0.41% 5/1208 • Number of events 5 • Adverse event data collected up to 2 week postpartum visit.	0.67% 8/1200 • Number of events 8 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Stillbirth	1.1% 13/1208 • Number of events 13 • Adverse event data collected up to 2 week postpartum visit.	1.6% 19/1200 • Number of events 19 • Adverse event data collected up to 2 week postpartum visit.
General disorders Maternal Death	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Gastrointestinal disorders Abdominal Pain	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Congenital Pneumonia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.33% 4/1208 • Number of events 4 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Gastrointestinal disorders Gastritis	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Gestational Hypertension	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Vascular disorders Hypertensive Crisis	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 3/1208 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.	0.25% 3/1200 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.
Reproductive system and breast disorders Pulmonary Oedema	0.33% 4/1208 • Number of events 4 • Adverse event data collected up to 2 week postpartum visit.	0.42% 5/1200 • Number of events 5 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Gastrointestinal disorders Vomiting	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Wound Infection	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.33% 4/1200 • Number of events 4 • Adverse event data collected up to 2 week postpartum visit.
Nervous system disorders Cerebrovascular Accident	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Renal and urinary disorders Acute Kidney Injury	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
General disorders Gravitational Oedema	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Pulmonary Arterial Hypertension	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions HELLP Syndrome	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Hepatobiliary disorders Hyperbilirubinaemia Neonatal	0.25% 3/1208 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Premature Rupture of Membranes	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Vascular disorders Hypertension	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Dysplasia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
General disorders Chest Pain	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Cleft Lip and Palate	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Congenital Genitourinary Abnormality	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Congenital Diaphragmatic Hernia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Diaphragmatic Aplasia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Metabolism and nutrition disorders Electrolyte Imbalance	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ganglioneuroma	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Holoprosencephaly	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Nervous system disorders Hypoxic-ischaemic Encephalopathy	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Neonatal Pneumonia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Neonatal Respiratory Distress	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Surgical and medical procedures Oesophageal Operation	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Cardiac disorders Palpitations	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Patent Ductus Arteriosus	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Placenta Accreta	0.33% 4/1208 • Number of events 4 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Pneumonia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Postpartum Haemorrhage	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Preterm Premature Rupture of Membranes	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Shoulder Dystocia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Trisomy 21	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.25% 3/1200 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Ventricular Septal Defect	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Trisomy 18	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Pyloric Stenosis	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Multiple Cardiac Defects	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.33% 4/1200 • Number of events 4 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Renal Aplasia	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Talipes	0.25% 3/1208 • Number of events 3 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Microcephaly	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Dandy-Walker syndrome	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Hypoplastic Left Heart Syndrome	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Kidney Malformation	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Atrial Septal Defect	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Anomalous Pulmonary Venous Connection	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Chondrodystrophy	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Injury, poisoning and procedural complications Subarachnoid Haemorrhage Neonatal	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Sepsis	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Reproductive system and breast disorders Shortened Cervix	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Renal and urinary disorders Renal Tubular Necrosis	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Nervous system disorders Seizure	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Purulent Discharge	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Cardiac disorders Supraventricular Extrasystoles	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Congenital, familial and genetic disorders Foetal Chromosome Abnormality	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
General disorders Oedema peripheral	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Appendicitis	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Urinary Tract Infection	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Injury, poisoning and procedural complications Anaesthetic complication	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Injury, poisoning and procedural complications Uterine rupture	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Investigations Blood pressure abnormal	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Nervous system disorders Headache	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Fetal growth restriction	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Hypothermia neonatal	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Neonatal disorder	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Poor weight gain neonatal	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Premature baby	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Renal and urinary disorders Hydronephrosis	0.08% 1/1208 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.17% 2/1200 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1208 • Adverse event data collected up to 2 week postpartum visit.	0.08% 1/1200 • Number of events 1 • Adverse event data collected up to 2 week postpartum visit.
Surgical and medical procedures Abdominal operation	0.17% 2/1208 • Number of events 2 • Adverse event data collected up to 2 week postpartum visit.	0.00% 0/1200 • Adverse event data collected up to 2 week postpartum visit.
General disorders General Event	0.99% 12/1208 • Number of events 12 • Adverse event data collected up to 2 week postpartum visit.	1.4% 17/1200 • Number of events 17 • Adverse event data collected up to 2 week postpartum visit.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alan Tita

University of Alabama at Birmingham

Phone: (205) 934-9616

Email: atita@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place