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

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: Not yet recruiting
• Conditions: Abnormal Uteroplacental Circulation
• Intervention / Treatment: Other: Doppler ultrasound measurement of changes in uterine artery blood flow

• Study Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pulsatility index	Pulsatility index of the left and right main uterine arteries	it can be monitored for up to 12 weeks
Resistive index	Resistive index of the left and right main uterine arteries	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	it can be monitored for up to 12 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID 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