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

NCT ID: NCT05554679

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-07-11

Brief Summary

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

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)

Conditions

Metformin for Obese Pregnant Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group A

obese pregnant women who take metformin

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: 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 B

obese pregnant women who take no metformin

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Ibram Samy

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abuelhasan

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29973490 (View on PubMed)

Other Identifiers

Metformin in preganancy

Identifier Type: -

Identifier Source: org_study_id