Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .
Primary Purpose
Metformin for Obese Pregnant Women
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Metformin for Obese Pregnant Women
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,
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
group A
group B
Arm Description
obese pregnant women who take metformin
obese pregnant women who take no metformin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05554679
Brief Title
Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .
Official Title
Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metformin for Obese Pregnant Women
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
metformin effect on prevention of macrosomia in obese pregnant women
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
obese pregnant women who take metformin
Arm Title
group B
Arm Type
No Intervention
Arm Description
obese pregnant women who take no metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal birth weight
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Maternal weight gain
Description
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
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew I. Samy
Phone
002/1029904818
Email
dr.andrewibram@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A. Abd El-Aleem
Phone
002/1068944114
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abuelhasan
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university
City
Asyut
ZIP/Postal Code
11117
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed abo elhasan Abo Elhasan, professor
Phone
01068944114
Email
Ml_abuelhasan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed ali abd El Abd El-Aleem, lecturer
Phone
01001085865
12. IPD Sharing Statement
Citations:
PubMed Identifier
29973490
Citation
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.
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Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .
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