Doppler Measurement of Uterine ArteryNCT06644911
Obesity Doppler in Term Pregnancy
An observational study of Doppler Measurement of Uterine Artery, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Doppler Measurement of Uterine Artery
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- 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].
Who cannot join
- Placenta previa
- Women with antepartum hemorrhage.
- Smokers and alcohol consumers
- Preeclampsia
- Diabetes mellitus
- Women need urgent termination of pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Woman's Health Hospital - Assiut university
Asyut, 71111
Mohammed K ALi, MD, +201005537951, m_khairy2001@yahoo.com
About this study
Official title: 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.
- Conditions
- Doppler Measurement of Uterine Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The difference between uterine and umbilical artery Doppler resistant index
The difference between uterine and umbilical artery Doppler indices between normal weight and obese pregnant women ≥ 37 weeks.
Measured: at 37 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start20 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doppler Measurement of Uterine ArteryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644911
- Sponsor's protocol ID
- Doppler-150
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Obesity on Umbilical and Uterine Artery Doppler in Term Pregnancy : a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06644911
- Acronym / sponsor ID
- Doppler-150
- Conditions
- Doppler Measurement of Uterine Artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (6 listed)
- 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].
Key exclusion criteria (6 listed)
- Placenta previa
- Women with antepartum hemorrhage.
- Smokers and alcohol consumers
- Preeclampsia
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Doppler Measurement of Uterine Artery, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Khairy Ali, MD (01005537951, mohammedelkosy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between uterine and umbilical artery Doppler resistant index (time frame: at 37 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.