## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** Metformin in preganancy
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2023-07-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-10

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2022-09-26
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-20
**Study First Submit QC Date:** 2022-09-22
**Why Stopped:** financial issues
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Andrew Ibram Samy

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Metformin for Obese Pregnant Women

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** metformin effect on prevention of macrosomia in obese pregnant women

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 178

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** obese pregnant women who take metformin

**Intervention Names:**

- Drug: Metformin

**Label:** group A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** obese pregnant women who take no metformin

**Label:** group B

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group A

**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.

**Name:** Metformin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Neonatal birth weight

**Time Frame:** Baseline

#### Secondary Outcomes

**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

**Measure:** Maternal weight gain

**Time Frame:** Baseline

### Eligibility Module

**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,

**Maximum Age:** 44 Years

**Minimum Age:** 17 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Asyut

**Country:** Egypt

**Facility:** Assiut university

**Zip:** 11117

#### Overall Officials

**Official 1:**

**Affiliation:** Assiut University

**Name:** Ahmed Abuelhasan

**Role:** STUDY_DIRECTOR

### References Module

#### References

**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.

**PMID:** 29973490

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obese

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

### Misc Info Module

- Version Holder: 2024-05-24
