Trial · NCT02932475

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

NCT02932475, Phase 3, Terminated, University of North Carolina, Chapel Hill; results first posted 2023-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD). Trials, record NCT02932475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02932475

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
NCT number: NCT02932475
Status: Terminated
Phases: Phase 3
Enrollment: 831 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Diabetes, Pregnancy
Interventions: Metformin, Placebo
First posted: 2016-10-13
Last updated: 2023-06-26
Results first posted: 2023-05-24

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Composite Adverse Neonatal Outcome	An average of 48 hours for term infants and 30 days for preterm infants	Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Small for gestational age infant (birth weight \< 10th percentile for gestational age) or low birth weight (\< 2500 gm)
Secondary	Number of Participants With Maternal Side Effects	Throughout study until delivery at 40 weeks gestation	Secondary outcome of maternal side effects were defined as: * clinically relevant hypoglycemia defined as capillary blood glucose \< 60 or \< 80 with symptoms * GI side effects defined as nausea, vomiting, diarrhea
Secondary	Mean Infant Fat Mass	Within 72 hrs of birth	Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat).
Secondary	Maternal Safety Based on Treatment Emergent Adverse Events	An average of 48 hours following delivery	Adverse maternal outcomes.
Secondary	Neonatal Safety Based on Treatment Emergent Adverse Events	up to 28 days of life	Adverse neonatal outcomes

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Composite Adverse Neonatal Outcome	An average of 48 hours for term infants and 30 days for preterm infants	Modified intent to treat population of all participants who took at least one dose of study agent and had primary outcome data available.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Maternal Side Effects	Throughout study until delivery at 40 weeks gestation		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Infant Fat Mass	Within 72 hrs of birth	Data are reported for those infants who underwent anthropomorphic measurements.	kg	MEAN
SECONDARY	Maternal Safety Based on Treatment Emergent Adverse Events	An average of 48 hours following delivery	Number of randomized participants who took at least one dose of study agent.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Neonatal Safety Based on Treatment Emergent Adverse Events	up to 28 days of life		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Composite Adverse Neonatal Outcome	Metformin		269		Participants
Number of Participants With Composite Adverse Neonatal Outcome	Placebo		277		Participants
Number of Participants With Maternal Side Effects	Metformin	Clinically relevant hypoglycemia	87		Participants
Number of Participants With Maternal Side Effects	Placebo	Clinically relevant hypoglycemia	85		Participants
Number of Participants With Maternal Side Effects	Metformin	Gastrointestinal side effects	182		Participants
Number of Participants With Maternal Side Effects	Placebo	Gastrointestinal side effects	171		Participants
Mean Infant Fat Mass	Maternal Metformin		0.46	Standard Deviation 0.3	kg
Mean Infant Fat Mass	Maternal Placebo		0.5	Standard Deviation 0.24	kg
Maternal Safety Based on Treatment Emergent Adverse Events	Metformin	Any adverse event leading to early study agent discontinuation	13		Participants
Maternal Safety Based on Treatment Emergent Adverse Events	Placebo	Any adverse event leading to early study agent discontinuation	20		Participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin	416
Overall Study	STARTED	Placebo	415
Overall Study	Randomized	Metformin	416
Overall Study	Randomized	Placebo	415
Overall Study	Received Intervention	Metformin	397
Overall Study	Received Intervention	Placebo	397
Overall Study	Liveborn Infants During Study	Metformin	376
Overall Study	Liveborn Infants During Study	Placebo	370
Overall Study	COMPLETED	Metformin	386
Overall Study	COMPLETED	Placebo	382

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events570

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Maternal Metformin	23	397	23
other	Abdominal pain	Gastrointestinal disorders	Fetus of Mother Receiving Metformin	0	397	0
other	Abdominal pain	Gastrointestinal disorders	Infants Born to Mothers Receiving Metformin	0	376	0
other	Abdominal pain	Gastrointestinal disorders	Maternal Placebo	20	397	20
other	Abdominal pain	Gastrointestinal disorders	Fetus of Mother Receiving Placebo	0	397	0
other	Abdominal pain	Gastrointestinal disorders	Infants Born to Mothers Receiving Placebo	0	370	0
other	Headache	Nervous system disorders	Maternal Metformin	31	397	31
other	Headache	Nervous system disorders	Fetus of Mother Receiving Metformin	0	397	0
other	Headache	Nervous system disorders	Infants Born to Mothers Receiving Metformin	0	376	0
other	Headache	Nervous system disorders	Maternal Placebo	36	397	36

1 to 10 of 570Source ClinicalTrials.gov

See all 570 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Maternal Metformin	2	397
Total, all-cause mortality	Fetus of Mother Receiving Metformin	10	397
Total, all-cause mortality	Infants Born to Mothers Receiving Metformin	1	376
Total, all-cause mortality	Maternal Placebo	1	397
Total, all-cause mortality	Fetus of Mother Receiving Placebo	10	397
Total, all-cause mortality	Infants Born to Mothers Receiving Placebo	2	370
Total, other adverse events	Maternal Metformin	54	397
Total, other adverse events	Fetus of Mother Receiving Metformin	0	397
Total, other adverse events	Infants Born to Mothers Receiving Metformin	151	376
Total, other adverse events	Maternal Placebo	57	397

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30541506	DERIVED	PubMed
38085312	DERIVED	PubMed
39236318	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD086139	Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD)	BOGGESS, KIM A; BERRY, DIANE C	UNIV OF NORTH CAROLINA CHAPEL HILL	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2021

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Metformin vs Placebo: Number of Participants With Composite Adverse Neonatal Outcome

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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