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

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06043804
Collaborator
(none)
200
30.9

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Doppler ultrasound measurement of changes in uterine artery blood flow

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

Arm Intervention/Treatment
healthy pregnant woman

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

Outcome Measures

Primary Outcome Measures

  1. Pulsatility index [it can be monitored for up to 12 weeks]

    Pulsatility index of the left and right main uterine arteries

  2. Resistive index [it can be monitored for up to 12 weeks]

    Resistive index of the left and right main uterine arteries

  3. Systolic-to-diastolic ratio [it can be monitored for up to 12 weeks]

    Systolic-to-diastolic ratio of the left and right main uterine arteries

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT06043804
Other Study ID Numbers:
  • SAHoWMU-CR2023-07-208
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 21, 2023