Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Sponsor

Gianna Wilkie (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04523363

Collaborator

(none)

240

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Condition or Disease	Intervention/Treatment	Phase
Prediabetes; Complicating Pregnancy	Drug: Metformin	Phase 4

Detailed Description

Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial.

Once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). A random number generator will allocate the participants to the study groups.

Women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. Those in the standard of care group will receive routine prenatal care. Both groups will undergo routine gestational diabetes testing by 28 weeks. Obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective, single center, randomized study evaluating metformin in the treatment of pregnant women with prediabetes on maternal and neonatal outcomes.This is a prospective, single center, randomized study evaluating metformin in the treatment of pregnant women with prediabetes on maternal and neonatal outcomes.

Masking:

Single (Outcomes Assessor)

Masking Description:

Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.

Primary Purpose:

Treatment

Official Title:

Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes: A Randomized Trial

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin Study subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.	Drug: Metformin Maximum dosage of 500 mg tablets 2 times a day (with each meal) Other Names: Glucophage
No Intervention: Standard of Care Study subjects will be randomized to standard of care and receive routine prenatal care without further intervention for their prediabetes.

Arm

Intervention/Treatment

Experimental: Metformin

Study subjects will be randomized to the metformin medication arm. They will take a 500 mg tablet orally twice a day starting at 14 weeks of pregnancy until delivery.

Drug: Metformin

Maximum dosage of 500 mg tablets 2 times a day (with each meal)

Other Names:

Glucophage

No Intervention: Standard of Care

Study subjects will be randomized to standard of care and receive routine prenatal care without further intervention for their prediabetes.

Outcome Measures

Primary Outcome Measures

Birth Weight [At Birth]
Used to determine large for gestational age status

Secondary Outcome Measures

Number of Participants needing Cesarean Section [At Delivery]
Number of Participants with Cesarean Section
Number of Participants with Postpartum Hemorrhage [At Delivery]
Estimated or quantitative blood loss greater than 1000 mL
Number of Participants with Development of Pregnancy Induced Hypertension [Through study completion, starting at 14 weeks until delivery]
Blood pressure, serum laboratory analysis, and urine protein would be assessed for diagnosis
Development of Gestational Diabetes [Assessed at 28 weeks of pregnancy]
A glucose tolerance test would be conducted at 28 weeks of pregnancy to diagnose diabetes
Maternal Weight Gain in Pregnancy [At enrollment and last prenatal visit, starting at 14 weeks until delivery]
Pregnancy Outcome [Through study completion, starting at 14 weeks until delivery]
Number of Participants with Stillbirth, livebirth, pregnancy loss
Number of Participants with Preterm birth [At delivery]
Less than 37 week delivery
Neonatal Intensive Care Unit Admission [At delivery and within first 2 days of life]
Admission to level 2 or greater neonatal ICU and length of stay
Apgar Score at Birth [At delivery]
<6 at 1 and 5 minutes
Number of Participants with Neonatal Birth Trauma [At Delivery]
Brachial plexus injury
Number of Participants with Shoulder Dystocia [At Delivery]
Number of Participants with Neonatal Hypoglycemia [Within first 2 days of life]
Number of Participants with Neonatal Respiratory Distress [At Delivery]
Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis
Number of Participants with Neonatal Hyperbilirubinemia [Within first 2 days of life]
Requiring phototherapy
Number of Participants requiring Neonatal Intubation [At Delivery]
Neonatal Cooling [Within first 2 days of life]
Need for neonatal cooling within first 48 hours of life
Umbilical Cord Blood Level of C-peptide [At Birth]
Umbilical Cord Blood Level of Leptin [At Birth]
Umbilical Cord Blood Level of Insulin [At Birth]
Placental Pathology [At Birth]
Assessing for malperfusion pathology

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
Patients able to provide written informed consent

Exclusion Criteria:

Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
Participants who are under the age of 18
Multiple Pregnancy
Patients already taking metformin for other indications
Fetal defect noted on early dating ultrasound
Miscarriage before randomization