Trial Outcomes & Findings for Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study (NCT NCT03076775)

NCT ID: NCT03076775

Last Updated: 2022-01-26

Results Overview

C-peptide level (ng/mL) as measure of fetal hyperinsulinemia

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: At delivery
• Results posted on: 2022-01-26

Participant Flow

Participant milestones

Measure	Intervention Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following Betamethasone (BMZ) administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days. Maternal glycemic control: Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals.	Usual Care Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
Overall Study STARTED	44	42
Overall Study Neonates Born During Study	43	42
Overall Study Umbilical Cord Blood Collected	33	38
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Intervention Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following Betamethasone (BMZ) administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days. Maternal glycemic control: Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals.	Usual Care Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Data unreported by 1 participant

Baseline characteristics by cohort

Measure	Intervention n=43 Participants Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.	Usual Care n=42 Participants Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.	Total n=85 Participants Total of all reporting groups
Age, Continuous	27 years n=43 Participants	28 years n=42 Participants	28 years n=85 Participants
Sex: Female, Male Female	43 Participants n=43 Participants	42 Participants n=42 Participants	85 Participants n=85 Participants
Sex: Female, Male Male	0 Participants n=43 Participants	0 Participants n=42 Participants	0 Participants n=85 Participants
Race/Ethnicity, Customized Non-Hispanic Black	17 Participants n=42 Participants • Data unreported by 1 participant	16 Participants n=42 Participants • Data unreported by 1 participant	33 Participants n=84 Participants • Data unreported by 1 participant
Race/Ethnicity, Customized Non-Hispanic White	17 Participants n=42 Participants • Data unreported by 1 participant	18 Participants n=42 Participants • Data unreported by 1 participant	35 Participants n=84 Participants • Data unreported by 1 participant
Race/Ethnicity, Customized Hispanic	8 Participants n=42 Participants • Data unreported by 1 participant	7 Participants n=42 Participants • Data unreported by 1 participant	15 Participants n=84 Participants • Data unreported by 1 participant
Race/Ethnicity, Customized Other	0 Participants n=42 Participants • Data unreported by 1 participant	1 Participants n=42 Participants • Data unreported by 1 participant	1 Participants n=84 Participants • Data unreported by 1 participant
Region of Enrollment United States	43 Participants n=43 Participants	42 Participants n=42 Participants	85 Participants n=85 Participants

PRIMARY outcome

Timeframe: At delivery

Population: Umbilical cord blood specimen only available for 70 neonates

C-peptide level (ng/mL) as measure of fetal hyperinsulinemia

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=33 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=37 Participants Neonates born to mothers who received usual care
Umbilical Cord Blood C-peptide	1.02 ng/mL Interval 0.52 to 1.86	1.09 ng/mL Interval 0.61 to 1.65

SECONDARY outcome

Timeframe: At delivery

Population: Umbilical cord blood specimen only available for 70 neonates

Cortisol level (ug/mL) as measure of fetal immune suppression

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=33 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=37 Participants Neonates born to mothers who received usual care
Umbilical Cord Blood Cortisol	2.0 ug/mL Interval 1.1 to 5.1	2.5 ug/mL Interval 1.7 to 5.9

SECONDARY outcome

Timeframe: At delivery

Population: Umbilical cord blood specimen only available for 71 neonates

Insulin-like growth factor 1 level (ng/mL) as a measure of in utero metabolic status

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=33 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=38 Participants Neonates born to mothers who received usual care
Umbilical Insulin-Like Growth Factor 1	78 ng/mL Interval 53.0 to 98.0	58 ng/mL Interval 42.0 to 90.0

SECONDARY outcome

Timeframe: At delivery

Population: Umbilical cord blood specimen only available for 71 neonates

Leptin level (ng/mL) as measure of fetal adiposity

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=33 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=38 Participants Neonates born to mothers who received usual care
Umbilical Cord Blood Leptin	7.5 ng/mL Interval 4.4 to 11.2	5.6 ng/mL Interval 3.2 to 12.6

SECONDARY outcome

Timeframe: After birth, up to 48 hours of life

Population: Glucose only available for 82 neonates

Number of neonates with capillary blood glucose < 40 mg/dL

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=41 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=41 Participants Neonates born to mothers who received usual care
Neonatal Hypoglycemia	20 Participants	21 Participants

SECONDARY outcome

Timeframe: After birth, during hospital admission, assessed up to 28 days

Population: Glucose only available for 82 neonates

Number of neonates with hypoglycemia requiring treatment with dextrose gel or dextrose intravenous fluids

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=41 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=41 Participants Neonates born to mothers who received usual care
Neonatal Hypoglycemia Treatment	9 Participants	8 Participants

SECONDARY outcome

Timeframe: After birth, during hospital admission, assessed up to 28 days

Population: Glucose only available on 82 neonates

Lowest neonatal capillary blood glucose (mg/dL)

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=41 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=41 Participants Neonates born to mothers who received usual care
Neonatal Glucose Nadir	42.3 mg/dL Standard Deviation 2.9	42.2 mg/dL Standard Deviation 2.2

SECONDARY outcome

Timeframe: After birth, during hospital admission, assessed up to 28 days

Population: Glucose only available on 82 neonates

Number of hours after birth when lowest neonatal capillary blood glucose was measured

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=41 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=41 Participants Neonates born to mothers who received usual care
Timing of Neonatal Blood Glucose Nadir	1.7 hours Interval 1.5 to 4.3	1.7 hours Interval 1.4 to 3.6

SECONDARY outcome

Timeframe: Date of delivery to date of discharge from hospital, assessed up to 28 days

Number of neonates admitted to the neonatal intensive care unit for > 24 hours

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=43 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=42 Participants Neonates born to mothers who received usual care
Neonatal Intensive Care Unit Admission	15 Participants	21 Participants

SECONDARY outcome

Timeframe: From neonatal intensive care unit admission to discharge, assessed up to 28 days

Number of days of neonatal intensive care unit stay

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=43 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=42 Participants Neonates born to mothers who received usual care
Neonatal Intensive Care Unit Length of Stay	6 days Interval 4.0 to 13.0	7 days Interval 2.0 to 11.0

SECONDARY outcome

Timeframe: After birth, during hospital admission, assessed up to 28 days

Number of neonates who had seizures

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=43 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=42 Participants Neonates born to mothers who received usual care
Neonatal Seizures	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After birth, during hospital admission, assessed up to 28 days

Number of neonates who died

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=43 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=42 Participants Neonates born to mothers who received usual care
Neonatal Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: For five days after first dose of betamethasone administration

Population: Only 39 participants in the intervention group had at least one capillary blood glucose measured

Number of mothers with intrapartum capillary blood glucose >110 mg/dL, fasting capillary blood glucose >95 mg/dL, or 1-hour postprandial capillary blood glucose >140 mg/dL

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=39 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care Neonates born to mothers who received usual care
Maternal Hyperglycemia	32 Participants	0 Participants

SECONDARY outcome

Timeframe: For five days after first dose of betamethasone administration

Population: Only 39 mothers in the intervention group had at least one capillary blood glucose measured

Number of mothers who received insulin for treatment of hyperglycemia

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=39 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care Neonates born to mothers who received usual care
Maternal Insulin Treatment	22 Participants	—

SECONDARY outcome

Timeframe: For five days after first dose of betamethasone administration

Population: Only 39 mothers in the intervention group had at least one capillary blood glucose measured

Number of mothers with capillary blood glucose <60 mg/dL

Outcome measures

Measure	Neonates Born to Mothers Receiving Intervention n=39 Participants Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care Neonates born to mothers who received usual care
Maternal Hypoglycemia	0 Participants	—

Adverse Events

Mothers: Intervention

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Mothers: Usual Care

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Neonates Born to Mothers Receiving Intervention

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Neonates Born to Mothers Receiving Usual Care

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mothers: Intervention n=44 participants at risk Mothers will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.	Mothers: Usual Care n=42 participants at risk Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.	Neonates Born to Mothers Receiving Intervention n=43 participants at risk Neonates born to mothers who received intervention	Neonates Born to Mothers Receiving Usual Care n=42 participants at risk Neonates born to mothers who received usual care
Endocrine disorders Neonatal Hypoglycemia	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	46.5% 20/43 • Number of events 20 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	50.0% 21/42 • Number of events 21 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
Respiratory, thoracic and mediastinal disorders Neonatal Respiratory Distress Syndrome	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	14.0% 6/43 • Number of events 6 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	9.5% 4/42 • Number of events 4 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
Respiratory, thoracic and mediastinal disorders Transient Tachypnea of the Newborn	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	7.0% 3/43 • Number of events 3 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	4.8% 2/42 • Number of events 2 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
Respiratory, thoracic and mediastinal disorders Neonatal Apnea	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	4.7% 2/43 • Number of events 2 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	9.5% 4/42 • Number of events 4 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
Hepatobiliary disorders Neonatal Hyperbilirubinemia	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	23.3% 10/43 • Number of events 10 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	42.9% 18/42 • Number of events 18 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
Reproductive system and breast disorders Cesarean delivery	25.6% 11/43 • Number of events 11 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	16.7% 7/42 • Number of events 7 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.
General disorders Neonatal Intensive Care Unit Admission	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	— 0/0 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	34.9% 15/43 • Number of events 15 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.	50.0% 21/42 • Number of events 21 • Collected for mothers from the time of informed consent until delivery or hospital discharge for a maximum of 5 days. For neonates, AEs were collected from the time of birth until discharge or 28 days of life.

Additional Information

Ashley Battarbee, MD, MSCR

University of North Carolina at Chapel Hill

Phone: 205-975-2361

Email: anbattarbee@uabmc.edu

Results disclosure agreements

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