Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Assiut University
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Neonatal birth weight
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 44 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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,
- •previous early pre-eclampsia,
Arms & Interventions
group A
obese pregnant women who take metformin
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Neonatal birth weight
Time Frame: Baseline
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.
Secondary Outcomes
- Maternal weight gain(Baseline)
Investigators
Andrew Ibram Samy
principal investigator
Assiut University