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

NCT05554679 | Terminated Phase 4

• 1 other identifier: Metformin in preganancy
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metformin for Obese Pregnant Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maternal weight gain

  Baseline

Study Arms (2)

group A

ACTIVE COMPARATOR

obese pregnant women who take metformin

Drug: Metformin

group B

NO INTERVENTION

obese pregnant women who take no metformin

Interventions

Metformin DRUG

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.

group A

Eligibility Criteria

• Age: 17 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 11117, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29973490 BACKGROUND

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ahmed Abuelhasan

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: metformin effect on prevention of macrosomia in obese pregnant women

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: September 26, 2022
• Study Start: February 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: July 11, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

EG (1)