Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion

September 12, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

Healthy pregnant women Group

Inclusion Criteria:

  1. Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
  2. Complete maternal clinical data;

Exclusion Criteria:

  1. The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;
  2. multiple pregnancy;
  3. Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;
  4. Patients who have chronic diseases or are receiving chronic treatment.

Pregnant women with recurrent pregnancy loss Group

Inclusion Criteria:

  1. Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;
  2. Complete maternal clinical data;
  3. There has been a history of spontaneous abortion with the same sexual partner for two or more consecutive times;

Exclusion Criteria:

  1. The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;
  2. multiple pregnancy;
  3. Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;
  4. Patients who have chronic diseases or are receiving chronic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy pregnant woman
Other: Doppler ultrasound measurement of changes in uterine artery blood flow
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
Other: Doppler ultrasound measurement of changes in uterine artery blood flow
Doppler ultrasound measurement of changes in uterine artery blood flow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulsatility index
Time Frame: it can be monitored for up to 12 weeks
Pulsatility index of the left and right main uterine arteries
it can be monitored for up to 12 weeks
Resistive index
Time Frame: it can be monitored for up to 12 weeks
Resistive index of the left and right main uterine arteries
it can be monitored for up to 12 weeks
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
it can be monitored for up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAHoWMU-CR2023-07-208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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