Obesity Doppler in Term Pregnancy

Recruiting

• Conditions: Doppler Measurement of Uterine Artery

• Registration Number: NCT06644911
• Lead Sponsor: Assiut University

Brief Summary

Maternal obesity is an epidemic in the developed world like Egypt. There are many pregnancy-associated complications including pre-eclampsia, gestational diabetes, and increased rates of septic wound after cesarean delivery. As a potential explanation of the etiology of complications due to maternal obesity, the role of endothelial dysfunction in the systemic and peripheral vasculatures has been hypothesized. It has been proposed that some adverse pregnancy outcomes in obese patients may be mediated by placental insufficiency. Utero-placental insufficiency is typically associated with fetal growth restriction and low birth weight.

Umbilical and uterine artery Doppler is widely accepted as a useful tool for monitoring high-risk pregnancies.

Normally, uterine artery vascular impedance gradually decreases until the late mid-trimester, owing to the establishment of a low-resistance placental circulation. Obesity has little impact on uterine vascular changes reflected by the early uterine artery PI. However, in the second trimester, extreme obesity appears to impair the normal continued drop in uterine vascular resistance. Many studies have examined the relationship between BMI and Doppler changes in high-risk pregnancies, but few have addressed these changes in low-risk pregnancies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Status Verified: 2025-01
• Study Start: 2025-01-20
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Singleton pregnancy
2. Gestational age ≥ 37 weeks
3. Absence of fetal structural abnormalities
4. Absence of maternal comorbidities and/or complications.
5. Obese women (BMI ≥ 30 kg/m2) [11].
6. Normal weight (BMI 18.5-24.9) [11].

Exclusion Criteria

1. Placenta previa
2. Women with antepartum hemorrhage.
3. Smokers and alcohol consumers
4. Preeclampsia
5. Diabetes mellitus
6. Women need urgent termination of pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between uterine and umbilical artery Doppler resistant index	at 37 weeks of pregnancy	The difference between uterine and umbilical artery Doppler indices between normal weight and obese pregnant women ≥ 37 weeks.

Trial Locations

Locations (1)

Woman's Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt