An observational study in Blood Loss, Repeat Cesarean Section and Maternal Transmission, sponsored by Peking University Third Hospital. Not yet recruiting. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by Peking University Third Hospital · Observational
This study is a prospective cohort study, led by Prof. Zhao Yangyu, from the Department of Gynecology \& Obstetrics, Peking University Third Hospital.
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 500 is above the median of 215 across 397 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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
Incidence of blood loss
blood loss
Time frame: delivery
Incidence of postpartum hemorrhage
postpartum hemorrhage
Time frame: delivery
Incidence of maternal transfusion
maternal transfusion
Time frame: delivery
Incidence of spontaneous abortion
spontaneous abortion
Time frame: delivery
Incidence of stillbirth
stillbirth
Time frame: delivery
Incidence of perinatal death
perinatal death
Time frame: 42 days postpartum
Maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy
Time frame: At 24-28 weeks
Maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy
Time frame: 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.
Time frame: At delivery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2022; primary completion for Aug 2023, 12 months later.
Of 133 non-industry observational studies under Hemorrhage, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's planned 12 months is below that.
Counting every sponsor, half of 157 studies reached it within 33 months; a quarter within 14 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital →