Abnormal Uteroplacental CirculationNCT06043804
Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
An observational study of Abnormal Uteroplacental Circulation, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Objective:To explore the study of Doppler ultrasound in first trimester pregnancies to measure the change of uterine artery blood flow in normal pregnancies and the prediction on abortion, which provides a certain reference for the change trend of uterine artery blood flow in normal first trimester pregnancies and the… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uteroplacental Circulation
- What is being tested?
- Doppler ultrasound measurement of changes in uterine artery blood flow
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: pregnant women
Who may be able to join
- Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
- Complete maternal clinical data;
- Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
- Complete maternal clinical data;
- There has been a history of spontaneous abortion with the same sexual partner for two or more consecutive times;
Who cannot join
- The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;
- multiple pregnancy;
- Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;
- Patients who have chronic diseases or are receiving chronic treatment.
- Pregnant women with recurrent pregnancy loss Group
- The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;
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- multiple pregnancy;
- Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;
- Patients who have chronic diseases or are receiving chronic treatment.
About this study
Objective:To explore the study of Doppler ultrasound in first trimester pregnancies to measure the change of uterine artery blood flow in normal pregnancies and the prediction on abortion, which provides a certain reference for the change trend of uterine artery blood flow in normal first trimester pregnancies and the prediction of Doppler ultrasound measurement in abortion.
Method:Pregnant women who underwent natural conception and single birth prenatal examination in the Obstetrics Department of the Second Affiliated Hospital of Wenzhou Medical University from October 1, 2023 to December 31, 2025 were selected as the study population. Eligible women were preliminarily screened according to the inclusion conditions of the study objects, and basic information of women in each group was compared: Maternal age, gestational time, birth time, gestational week, abortion history, maternal BMI, maternal MAP, smoking status, serum HCG, subchorionic hematoma, fetal bradycardia, left and right uterine aorta pulse index (PI), resistance index (RI) and systolic/diastolic ratio (S/D), etc. To investigate the effect of Doppler ultrasonography on the measurement of uterine artery blood flow in normal pregnancy and the prediction of abortion.
- Conditions
- Abnormal Uteroplacental Circulation
- Being tested
- Doppler ultrasound measurement of changes in uterine artery blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasound measurement of changes in uterine artery blood flowOther
Doppler ultrasound measurement of changes in uterine artery blood flow
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant woman | healthy pregnant woman Receives: Other: Doppler ultrasound measurement of changes in uterine artery blood flow | |
| Pregnant women with recurrent pregnancy loss | Spontaneous abortion of three or more consecutive sexual partners Receives: Other: Doppler ultrasound measurement of changes in uterine artery blood flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index
Pulsatility index of the left and right main uterine arteries
Measured: it can be monitored for up to 12 weeks
Resistive index
Resistive index of the left and right main uterine arteries
Measured: it can be monitored for up to 12 weeks
Systolic-to-diastolic ratio
Systolic-to-diastolic ratio of the left and right main uterine arteries
Measured: it can be monitored for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uteroplacental CirculationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043804
- Sponsor's protocol ID
- SAHoWMU-CR2023-07-208
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
- ClinicalTrials.gov ID
- NCT06043804
- Acronym / sponsor ID
- SAHoWMU-CR2023-07-208
- Conditions
- Abnormal Uteroplacental Circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Objective:To explore the study of Doppler ultrasound in first trimester pregnancies to measure the change of uterine artery blood flow in normal pregnancies and the prediction on abortion, which provides a certain reference for the change trend of uterine artery blood flow in normal first trimester pregnancies and the prediction of Doppler ultrasound measurement in abortion.
Method:Pregnant women who underwent natural conception and single birth prenatal examination in the Obstetrics Department of the Second Affiliated Hospital of Wenzhou Medical University from October 1, 2023 to December 31, 2025 were selected as the study population. Eligible women were preliminarily screened according to the inclusion conditions of the study objects, and basic information of women in each group was compared: Maternal age, gestational time, birth time, gestational week, abortion history, maternal BMI, maternal MAP, smoking status, serum HCG, subchorionic hematoma, fetal bradycardia, left and right uterine aorta pulse index (PI), resistance index (RI) and systolic/diastolic ratio (S/D), etc. To investigate the effect of Doppler ultrasonography on the measurement of uterine artery blood flow in normal pregnancy and the prediction of abortion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant woman | – | Other: Doppler ultrasound measurement of changes in uterine artery blood flowhealthy pregnant woman |
| Pregnant women with recurrent pregnancy loss | – | Other: Doppler ultrasound measurement of changes in uterine artery blood flowSpontaneous abortion of three or more consecutive sexual partners |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pregnant women
Key inclusion criteria (5 listed)
- Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
- Complete maternal clinical data;
- Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
- Complete maternal clinical data;
- There has been a history of spontaneous abortion with the same sexual partner for two or more consecutive times;
Key exclusion criteria (9 listed)
- The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;
- multiple pregnancy;
- Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;
- Patients who have chronic diseases or are receiving chronic treatment.
- Pregnant women with recurrent pregnancy loss Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler ultrasound measurement of changes in uterine artery blood flowDoppler ultrasound measurement of changes in uterine artery blood flow | Other | Pregnant women with recurrent pregnancy loss, healthy pregnant woman |
Primary outcome
Pulsatility index
Time frame: it can be monitored for up to 12 weeks
Pulsatility index of the left and right main uterine arteries
Resistive index
Time frame: it can be monitored for up to 12 weeks
Resistive index of the left and right main uterine arteries
Systolic-to-diastolic ratio
Time frame: it can be monitored for up to 12 weeks
Systolic-to-diastolic ratio of the left and right main uterine arteries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uteroplacental Circulation, run by Second Affiliated Hospital of Wenzhou Medical University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsatility index (time frame: it can be monitored for up to 12 weeks). The study lists 3 primary outcomes in all. 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 21 Sep 2023.