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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05481606
Other study ID # PKUTH22-07-27
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2025

Study information

Verified date July 2022
Source Peking University Third Hospital
Contact Yangyu Zhao, MD
Phone 13701118357
Email zhaoyangyu@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is a prospective cohort study, led by Prof. Zhao Yangyu, from the Department of Gynecology & Obstetrics, Peking University Third Hospital.


Description:

Cesarean section, myomectomy and other surgeries for uterus are likely to cause scars in different parts of the uterus. During the subsequent pregnancy, the incidence rate of cesarean scar pregnancy, placenta previa, placenta increta and the risk of termination of the first and mid-trimester pregnancy is likely to increase. Cesarean scar pregnancy is regarded as a risk factor of uterine rupture in the third trimester of pregnancy or delivery period, which severely affects the maternal and perinatal health and safety. This study is planning to prospectively include pregnant women aged 20-49 years from Peking University Third Hospital. All women with diagnosis on cesarean scar pregnancy was included prior to 14 wks of gestation. We divided the women into three different groups: type I, type II and type III according to characteristics in gestation sac,uterine scar, bladder, the latter with potentially worse outcomes in term of maternal morbidity and mortality. Data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date August 1, 2025
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 49 Years
Eligibility Inclusion Criteria: - Female aged = 20 years - Female with cesarean scar pregnancy - Less than 14 gestational weeks - Planning to receive prenatal healthcare and delivery service at the study hospital Exclusion Criteria: - Inability to provide informed consent - Women with mental disorders

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of blood loss blood loss delivery
Primary Incidence of postpartum hemorrhage postpartum hemorrhage delivery
Primary Incidence of maternal transfusion maternal transfusion delivery
Primary Incidence of spontaneous abortion spontaneous abortion delivery
Primary Incidence of stillbirth stillbirth delivery
Primary Incidence of perinatal death perinatal death 42 days postpartum
Secondary Maternal death Deaths during pregnancy or less than 42 days after termination of pregnancy At 24-28 weeks
Secondary Maternal death Deaths during pregnancy or less than 42 days after termination of pregnancy 42 days postpartum
Secondary The rate of repeated cesarean delivery Cesarean rate is defined as the number of cesarean delivery divided by the number of live births. At delivery
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