Clinical trial NCT06043804: Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
Official title: Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abnormal Uteroplacental Circulation
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pulsatility index
timeFrame: it can be monitored for up to 12 weeks
measure: Resistive index
timeFrame: it can be monitored for up to 12 weeks
measure: Systolic-to-diastolic ratio
timeFrame: it can be monitored for up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: