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Clinical Trials/NCT05481606
NCT05481606Not yet recruitingNot Applicable

Clinical Outcomes of Cesarean Scar Pregnancy With Different Type: a Prospective Cohort Study

Peking University Third Hospital0 sites500 target enrollmentStarted: August 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
500
Primary Endpoint
Incidence of blood loss

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 49 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Incidence of blood loss

Time Frame: delivery

blood loss

Incidence of perinatal death

Time Frame: 42 days postpartum

perinatal death

Incidence of postpartum hemorrhage

Time Frame: delivery

postpartum hemorrhage

Incidence of spontaneous abortion

Time Frame: delivery

spontaneous abortion

Incidence of maternal transfusion

Time Frame: delivery

maternal transfusion

Incidence of stillbirth

Time Frame: delivery

stillbirth

Secondary Outcomes

  • Maternal death(42 days postpartum)
  • The rate of repeated cesarean delivery(At delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhao Yangyu

Chief of obstetrics

Peking University Third Hospital

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