Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .

Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.

To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome.

Study Overview

• Status: Terminated
• Conditions: Metformin for Obese Pregnant Women
• Intervention / Treatment: Drug: Metformin

Detailed Description

Obesity is defined as having an excessive amount of body fat based on the BMI, Obesity can be classified based on the BMI to obese class I ,Class II ,and extreme obesity (class III) , Obesity can harm the fertility by inhibiting normal ovulation. Even in women who regularly ovulate, the greater the BMI, the longer it appears to take to become pregnant. Obesity can also affect the outcome of in vitro fertilization (IVF). (1)

Being obese during pregnancy increases the risk of various pregnancy complications, including :

Miscarriage ,stillbirth ,GD , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for C-section ,and complication of C-section ,Fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make It may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) .

Normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) KG .

Normal weight gain during pregnancy for obese women having Multiple pregnancy is between about (11-19) KG (4).

For women who are extremely obese, gaining less than the recommended amount or losing weight during pregnancy might lower the risk of fetal and neonatal macrosomia .

The fetus is regarded as suspected appropriate or gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile (5) .

A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age (6,7,8) .

In this study the investigator will try to focus on diagnose undiagnosed diabetic using GTT (glucose tolerance test specially with women who has one or more risk factors A raised body mass index (BMI) over 30kg/m². A previous baby over 4kg or more ,Confirmed gestational diabetes in a previous pregnancy or have a first degree relative that has diabetes All pregnant women who have not already been diagnosed with diabetes should be screened for Diabetes with a fasting plasma glucose (FPG), an HbA1c, or an untimed random plasma glucose test at their first prenatal visit

• Women who by 24 weeks' gestation have not yet been diagnosed with overt or gestational diabetes should, at between 24 and 28 weeks' gestation, undergo a 2-hour, 75-g OGTT for gestational diabetes
• At 24-28 weeks' gestation, a result of 153-199 mg/dL for a 2-hour, 75-g OGTT indicates gestational diabetes, while a test result of 200 mg/dL or higher indicates overt diabetes(9),(10)

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 11117
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pregnant women with BMI ≥ 30 kg/m2, and normal glucose tolerance test.

Exclusion Criteria:

• pregnant women who are diabetic,
• had a history of previous GDM,
• previous small baby,
• PCO or
• previous early pre-eclampsia,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; obese pregnant women who take metformin	Drug: Metformin; Metformin is an oral insulin-sensitising medication that acts to decrease blood glucose concentrations. It inhibits pathways in the liver that stimulate glucose production and also acts to increase glucose uptake into skeletal muscle and fat cells . Metformin is commonly used in the treatment of type 2 diabetes mellitus and polycystic ovarian syndrome , and is being used increasingly in the treatment of gestational diabetes, having been shown to result in decreased rates of neonatal hypoglycaemia and no increased risk of adverse maternal outcomes when compared with insulin.
No Intervention: group B; obese pregnant women who take no metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal birth weight	The fetus is regarded as suspected appropriate for gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile ,A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal weight gain	Health care providers who care for pregnant women should determine a woman's body mass index at the initial prenatal visit and counsel her regarding the benefits of appropriate weight gain, nutrition and exercise, and, especially, the need to limit excessive weight gain to achieve best pregnancy outcome . for women of normal weight, 14.1-22.7 kg (31-50 lb) for overweight women, and 11.3-19.1 kg (25-42 lb) for obese women	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed Abuelhasan, Assiut University

Publications and helpful links

General Publications

• Hyer S, Balani J, Shehata H. Metformin in Pregnancy: Mechanisms and Clinical Applications. Int J Mol Sci. 2018 Jul 4;19(7):1954. doi: 10.3390/ijms19071954.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: Metformin in preganancy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No