Cesarean Scar Pregnancy and Clinical Outcomes

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05481606
• Other study ID #: PKUTH22-07-27
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Abortion
• Blood Loss
• Hysterectomy
• Placenta Accreta
• Placenta Accreta Spectrum
• Repeat Cesarean Section

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