Cesarean Scar Pregnancy and Clinical Outcomes

NCT ID: NCT05481606

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-08-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type I

1\) the gestational sac is partially implanted in the uterine scar, partially or mostly located in the uterine cavity, and a few may even reach the uterine cavity at the bottom of the palace; 2) the gestational sac is significantly deformed, and elongated, and its the lower end presented a acute Angle; 3) The myometrium between the gestational sac and the bladder became thinner, with a thickness of \>3 mm; 4) Doppler flow image: trophoblast blood flow signal can be seen in the scar (low resistance blood flow)

No interventions assigned to this group

Type II

1\) The gestating sac is partially implanted in the scar of the uterus, partially or mostly located in the uterine cavity, and a few may even reach the uterine cavity at the bottom of the uterus; 2)the gestational sac is significantly deformed, and elongated, and its the lower end presented a acute Angle; 3) The myometrium between the stretch and the bladder becomes thinner (3 mm in thickness); 4) color Doppler flow image: trophoblast blood flow signal (low resistance blood flow) can be seen in the scar.

No interventions assigned to this group

Type III

1\) The gestating sac is completely implanted in the muscle layer of the scar of the uterus and protrudes outward toward the bladder; 2) Uterine cavity and cervical canal emptiness; 3) The myometrium between the gestational sac and the bladder was significantly thinner or absent, with a thickness of 3 mm; 4) color Doppler flow image: trophoblast blood flow signal (low resistance blood flow) can be seen in the scar. Among them, there is a special ultrasonic manifestation of cesarean scar pregnancy in type III, namely mass type, whose sonographic characteristics

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Yangyu

Chief of obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yangyu Zhao, MD

Role: CONTACT

zhaoyangyu@bjmu.edu.cn

13701118357

Other Identifiers

PKUTH22-07-27

Identifier Type: -

Identifier Source: org_study_id