Obesity Doppler in Term Pregnancy

NCT ID: NCT06644911

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2026-01-31

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.

Conditions

Doppler Measurement of Uterine Artery

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal weight pregnant women

Normal weight (body mass index 18.5-24.9 kg/m2)

No interventions assigned to this group

Obese pregnant women

women (body mass index ≥ 30 kg/m2)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Woman's Health Hospital - Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed Khairy Ali, MD

Role: CONTACT

mohammedelkosy@aun.edu.eg

01005537951

Facility Contacts

Mohammed K ALi, MD

Role: primary

m_khairy2001@yahoo.com

+201005537951

Other Identifiers

Doppler-150

Identifier Type: -

Identifier Source: org_study_id