Blood LossNCT05481606
Cesarean Scar Pregnancy and Clinical Outcomes
An observational study of Blood Loss and Repeat Cesarean Section, run by Peking University Third Hospital.
Trial summary
This study is a prospective cohort study, led by Prof. Zhao Yangyu, from the Department of Gynecology \& Obstetrics, Peking University Third Hospital. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Repeat Cesarean Section, Maternal Transmission
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Aug 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Women with mental disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Outcomes of Cesarean Scar Pregnancy With Different Type: a Prospective Cohort Study
This study is a prospective cohort study, led by Prof. Zhao Yangyu, from the Department of Gynecology \& Obstetrics, Peking University Third Hospital.
Read the 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
- Medical subject headings
- Hemorrhage, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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. | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of blood loss
blood loss
Measured: delivery
Incidence of postpartum hemorrhage
postpartum hemorrhage
Measured: delivery
Incidence of maternal transfusion
maternal transfusion
Measured: delivery
Incidence of spontaneous abortion
spontaneous abortion
Measured: delivery
Incidence of stillbirth
stillbirth
Measured: delivery
Incidence of perinatal death
perinatal death
Measured: 42 days postpartum
Secondary outcomes (3)
Maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy
Measured: At 24-28 weeks
Maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy
Measured: 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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Yangyu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481606
- Sponsor's protocol ID
- PKUTH22-07-27
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Cesarean Scar Pregnancy With Different Type: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05481606
- Acronym / sponsor ID
- PKUTH22-07-27
- Conditions
- Blood Loss, Repeat Cesarean Section, Maternal Transmission, Hysterectomy, Placenta Accreta Spectrum, Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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. |
| 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 |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Women with mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of blood loss
Time frame: delivery
blood loss
Incidence of postpartum hemorrhage
Time frame: delivery
postpartum hemorrhage
Incidence of maternal transfusion
Time frame: delivery
maternal transfusion
Incidence of spontaneous abortion
Time frame: delivery
spontaneous abortion
Incidence of stillbirth
Time frame: delivery
stillbirth
Incidence of perinatal death
Time frame: 42 days postpartum
perinatal death
3 secondary outcomes
Maternal death
Time frame: At 24-28 weeks
Maternal death
Time frame: 42 days postpartum
The rate of repeated cesarean delivery
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss and Repeat Cesarean Section, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangyu Zhao, MD (13701118357, zhaoyangyu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of blood loss (time frame: delivery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.