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

Browse trials for

• Pregnancy Complications 437
• Diabetes Mellitus 10,925

Keywords

• Metformin
• Glucophage
• Riomet
• Glumetza
• Fortamet
• Glucophage XR

Pregnancy Complications

437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.

This study's enrollment of 831 is above the median of 147 across 220 interventional studies indexed under Pregnancy Complications.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Study arms

• Active comparator
  Treatment

  Metformin 1000 mg twice a day

  Drug: Metformin

• Sham comparator
  Placebo

  Placebo, identical to Metformin

  Drug: Placebo

Interventions

• DrugMetformin

  1000 mg twice a day

  Also known as: Glumetza, Fortamet, Glucophage, Riomet

• DrugPlacebo

  Delivered to match active drug

  Also known as: Sugar pill

Primary outcomes

1. Number of Participants With Composite Adverse Neonatal Outcome

   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)

   Time frame: An average of 48 hours for term infants and 30 days for preterm infants

Secondary outcomes

1. Number of Participants With Maternal Side Effects

   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

   Time frame: Throughout study until delivery at 40 weeks gestation

2. Mean Infant Fat Mass

   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).

   Time frame: Within 72 hrs of birth

3. Maternal Safety Based on Treatment Emergent Adverse Events

   Adverse maternal outcomes.

   Time frame: An average of 48 hours following delivery

4. Neonatal Safety Based on Treatment Emergent Adverse Events

   Adverse neonatal outcomes

   Time frame: up to 28 days of life

Baseline characteristics

Publications

• Berry DC, Thomas SD, Dorman KF, Ivins AR, de Los Angeles Abreu M, Young L, Boggess K. Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. BMC Pregnancy Childbirth. 2018 Dec 12;18(1):488. doi: 10.1186/s12884-018-2108-3. PubMed 30541506 ↗

Study documents

• Protocol and statistical analysis plan · Jun 12, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes