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

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ClinicalTrials.gov Identifier: NCT02932475
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE October 13, 2016
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE May 25, 2017
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Composite adverse neonatal outcome [ Time Frame: An average of 48 hours for term infants and 30 days for preterm infants ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • Maternal safety [ Time Frame: An average of 48 hours following delivery ]
    Adverse maternal outcomes, e.g. death, diabetic ketoacidosis, hypoglycemia requiring medical therapy, ICU admission/intubation, renal failure • Maternal obstetrical complications, e.g. placental abruption, preeclampsia
  • Infant fat mass [ Time Frame: Within 72 hrs of birth ]
    Percent neonatal fat mass measured by skin-fold thickness (anthropometrics) measured at flank, biceps and sub scapular
  • Maternal side effects [ Time Frame: Throughout study until delivery at 40 weeks gestation ]
    Maternal clinically relevant hypoglycemia defined as capillary blood glucose < 60 or < 80 with symptoms • Maternal side effects such as nausea, vomiting, diarrhea that cannot be managed with oral medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Official Title  ICMJE Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
Brief Summary

Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.

Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers

Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Pregnancy
Intervention  ICMJE
  • Drug: Metformin
    1000 mg twice a day
    Other Names:
    • Glumetza
    • Fortamet
    • Glucophage
    • Riomet
  • Drug: Placebo
    Delivered to match active drug
    Other Name: Sugar pill
Study Arms  ICMJE
  • Active Comparator: Treatment
    Metformin 1000 mg twice a day
    Intervention: Drug: Metformin
  • Sham Comparator: Placebo
    Placebo, identical to Metformin
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2019)
950
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2016)
1200
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Maternal age 18-45 years
  • Singleton pregnancy with no known fetal anomalies
  • Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound, or ultrasound alone
  • Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or insulin)
  • Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days gestation
  • Willing to start insulin therapy and discontinue oral hypoglycemic pills other than study pills
  • Able to swallow pills

Exclusion Criteria:

  • Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL
  • Clinical history of lactic acidosis
  • Known allergy to metformin
  • Participation in another study that could affect primary outcome
  • Delivery planned at non-MOMPOD study locations
  • Unwillingness to use insulin treatment or follow prenatal care doctor's instructions for insulin and blood glucose monitoring
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amber Irvins (919) 843-4420 amber_irvins@med.unc.edu
Contact: Karen Dorman (984) 974-9012 kdorman@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02932475
Other Study ID Numbers  ICMJE 15-3235
1R01HD086139-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Kim Boggess, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP