- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06644911
Obesity Doppler in Term Pregnancy
The Effect of Maternal Obesity on Umbilical and Uterine Artery Doppler in Term Pregnancy : a Cross-sectional Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohammed Khairy Ali, MD
- Phone Number: 01005537951
- Email: mohammedelkosy@aun.edu.eg
Study Locations
-
-
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Assiut, Egypt, 71111
- Recruiting
- Woman's Health Hospital - Assiut university
-
Contact:
- Mohammed K ALi, MD
- Phone Number: +201005537951
- Email: m_khairy2001@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Absence of fetal structural abnormalities
- Absence of maternal comorbidities and/or complications.
- Obese women (BMI ≥ 30 kg/m2) [11].
- Normal weight (BMI 18.5-24.9) [11].
Exclusion Criteria:
- Placenta previa
- Women with antepartum hemorrhage.
- Smokers and alcohol consumers
- Preeclampsia
- Diabetes mellitus
- Women need urgent termination of pregnancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Normal weight pregnant women
Normal weight (body mass index 18.5-24.9
kg/m2)
|
|
Obese pregnant women
women (body mass index ≥ 30 kg/m2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference between uterine and umbilical artery Doppler resistant index
Time Frame: at 37 weeks of pregnancy
|
The difference between uterine and umbilical artery Doppler indices between normal weight and obese pregnant women ≥ 37 weeks.
|
at 37 weeks of pregnancy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doppler-150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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