Clinical trial NCT05481606: Cesarean Scar Pregnancy and Clinical Outcomes
Official title: Clinical Outcomes of Cesarean Scar Pregnancy With Different Type: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Loss
Repeat Cesarean Section
Maternal Transmission
Hysterectomy
Placenta Accreta Spectrum
Abortion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is planning to include 1000 pregnant women with uterine scar aged 20 years from Peking University Third Hospital. Pregnant women who are planning to recieve prenatal healthcare and delivery in this hospital are potential candidates for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of blood loss
timeFrame: delivery
measure: Incidence of postpartum hemorrhage
timeFrame: delivery
measure: Incidence of maternal transfusion
timeFrame: delivery
measure: Incidence of spontaneous abortion
timeFrame: delivery
measure: Incidence of stillbirth
timeFrame: delivery
measure: Incidence of perinatal death
timeFrame: 42 days postpartum
Secondary outcomes:
measure: Maternal death
timeFrame: At 24-28 weeks
measure: Maternal death
timeFrame: 42 days postpartum
measure: The rate of repeated cesarean delivery
timeFrame: At delivery
Other outcomes:
Locations:
Study officials:
References: