Cesarean Scar Pregnancy and Clinical Outcomes

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

Detailed Description
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type I<br>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) | |
| Type II<br>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. | |
| Type III<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of blood loss | blood loss | delivery | 
| Incidence of postpartum hemorrhage | postpartum hemorrhage | delivery | 
| Incidence of maternal transfusion | maternal transfusion | delivery | 
| Incidence of spontaneous abortion | spontaneous abortion | delivery | 
| Incidence of stillbirth | stillbirth | delivery | 
| Incidence of perinatal death | perinatal death | 42 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal death | Deaths during pregnancy or less than 42 days after termination of pregnancy | At 24-28 weeks | 
| Maternal death | Deaths during pregnancy or less than 42 days after termination of pregnancy | 42 days postpartum | 
| 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 |