Trial Outcomes & Findings for Early Gestational Diabetes Screening in the Gravid Obese Woman (NCT NCT01864564)

NCT ID: NCT01864564

Last Updated: 2020-06-23

Results Overview

Any one of the following: Macrosomia (birth weight \> 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (\<40 mg/dL)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 962 participants
• Primary outcome timeframe: Baseline to within 6 weeks of delivery
• Results posted on: 2020-06-23

Participant Flow

Participant milestones

Measure	Routine Screening Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Overall Study STARTED	480	482
Overall Study COMPLETED	443	387
Overall Study NOT COMPLETED	37	95

Reasons for withdrawal

Measure	Routine Screening Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Overall Study Lost to Follow-up	17	23
Overall Study Withdrawal by Subject	20	11
Overall Study Protocol Violation	0	27
Overall Study not reported	0	34

Baseline Characteristics

Early Gestational Diabetes Screening in the Gravid Obese Woman

Baseline characteristics by cohort

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.	Total n=922 Participants Total of all reporting groups
Age, Continuous	26.8 years STANDARD_DEVIATION 5.9 • n=5 Participants	27.2 years STANDARD_DEVIATION 5.9 • n=7 Participants	27 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex/Gender, Customized female	463 Participants n=5 Participants	459 Participants n=7 Participants	922 Participants n=5 Participants
Race/Ethnicity, Customized White, Non-Hispanic	35 Participants n=5 Participants	52 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized Black, Non-Hispanic	299 Participants n=5 Participants	280 Participants n=7 Participants	579 Participants n=5 Participants
Race/Ethnicity, Customized Native American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	123 Participants n=5 Participants	122 Participants n=7 Participants	245 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	463 participants n=5 Participants	459 participants n=7 Participants	922 participants n=5 Participants
Body Mass index at randomization	37.0 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants	37.2 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	37 kg/m^2 STANDARD_DEVIATION 0.6 • n=5 Participants
Medicaid/no insurance	441 Participants n=5 Participants	434 Participants n=7 Participants	875 Participants n=5 Participants
Married	96 Participants n=5 Participants	98 Participants n=7 Participants	194 Participants n=5 Participants
High School education or greater	305 Participants n=5 Participants	309 Participants n=7 Participants	614 Participants n=5 Participants
Parous	338 Participants n=5 Participants	329 Participants n=7 Participants	667 Participants n=5 Participants
Any Smoking	98 Participants n=5 Participants	83 Participants n=7 Participants	181 Participants n=5 Participants
Any alcohol use	61 Participants n=5 Participants	76 Participants n=7 Participants	137 Participants n=5 Participants
Any drug use	49 Participants n=5 Participants	41 Participants n=7 Participants	90 Participants n=5 Participants
Hypertension	50 Participants n=5 Participants	61 Participants n=7 Participants	111 Participants n=5 Participants
Asthma	53 Participants n=5 Participants	61 Participants n=7 Participants	114 Participants n=5 Participants
Depression	50 Participants n=5 Participants	55 Participants n=7 Participants	105 Participants n=5 Participants
Hemoglobin A1c at 14-20 weeks	5.3 % A1c n=5 Participants	5.3 % A1c n=7 Participants	5.3 % A1c n=5 Participants
Gestational age at Randomization	13.6 weeks STANDARD_DEVIATION 3.7 • n=5 Participants	13.8 weeks STANDARD_DEVIATION 3.8 • n=7 Participants	13.7 weeks STANDARD_DEVIATION 3.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to within 6 weeks of delivery

Any one of the following: Macrosomia (birth weight > 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (<40 mg/dL)

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Number of Participants With a Composite Perinatal Outcome	235 Participants	261 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Number of infants with Birth weight >4000 g

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Number of Participants With Macrosomia	21 Participants	25 Participants

SECONDARY outcome

Timeframe: Delivery

Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries)

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Primary Cesarean Delivery	93 Participants	79 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Includes gestational hypertension and preeclampsia

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Pregnancy Induced Hypertension	102 Participants	136 Participants

SECONDARY outcome

Timeframe: At birth

Shoulder dystocia as identified by delivering physician

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Shoulder Dystocia	32 Participants	30 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

serum bilirubin level above the 95th percentile for gestational age

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Neonatal Hyperbilirubinemia	72 Participants	90 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Blood sugar level <40 mg/dL

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Neonatal Hypoglycemia	19 Participants	22 Participants

SECONDARY outcome

Timeframe: at delivery

Gestational age in weeks as calculated by ACOG criteria

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Gestational Age at Delivery	38.5 weeks Standard Deviation 3.4	38.2 weeks Standard Deviation 4.4

SECONDARY outcome

Timeframe: baseline to delivery

includes the use of any diabetic medication

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Any Diabetic Medication	20 Participants	31 Participants

SECONDARY outcome

Timeframe: baseline to delivery

Includes the use of Insulin

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Insulin Medication	3 Participants	11 Participants

SECONDARY outcome

Timeframe: at delivery

defined as >= the 90th percentile by Duryea et al

Outcome measures

Measure	Routine Screening n=463 Participants Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 Participants Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Large for Gestational Age	26 Participants	27 Participants

Adverse Events

Routine Screening

Serious events: 10 serious events

Other events: 1 other events

Deaths: 10 deaths

Early Screening

Serious events: 22 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Measure	Routine Screening n=463 participants at risk Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 participants at risk Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Pregnancy, puerperium and perinatal conditions Fetal or Neonatal death	2.2% 10/463 • Number of events 10 • Baseline through 8 months	4.8% 22/459 • Number of events 22 • Baseline through 8 months

Other adverse events

Measure	Routine Screening n=463 participants at risk Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.	Early Screening n=459 participants at risk Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
Pregnancy, puerperium and perinatal conditions Other - Preterm Delivery	0.22% 1/463 • Number of events 1 • Baseline through 8 months	0.00% 0/459 • Baseline through 8 months

Additional Information

Lorie M. Harper, MD, MSCI

University of Texas at Austin

Phone: 512-324-7036

Email: lorie.harper@austin.utexas.edu

Results disclosure agreements

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