Cesarean Scar Pregnancy and Clinical Outcomes

Not yet recruiting

• Conditions: Repeat Cesarean Section; Placenta Accreta Spectrum; Blood Loss; Maternal Transmission; Hysterectomy; Abortion

• Registration Number: NCT05481606
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study Start: 2022-08-01
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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

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Exclusion Criteria

• Inability to provide informed consent
• Women with mental disorders

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of blood loss	delivery	blood loss
Incidence of perinatal death	42 days postpartum	perinatal death
Incidence of postpartum hemorrhage	delivery	postpartum hemorrhage
Incidence of stillbirth	delivery	stillbirth
Incidence of maternal transfusion	delivery	maternal transfusion
Incidence of spontaneous abortion	delivery	spontaneous abortion

Secondary Outcome Measures

Name	Time	Method
Maternal death	42 days postpartum	Deaths during pregnancy or less than 42 days after termination of pregnancy
The rate of repeated cesarean delivery	At delivery	Cesarean rate is defined as the number of cesarean delivery divided by the number of live births.