NCT05481606

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

July 27, 2022

Last Update Submit

July 28, 2022

Conditions

Blood LossRepeat Cesarean SectionMaternal TransmissionHysterectomyPlacenta Accreta SpectrumAbortion

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Maternal death

    At 24-28 weeks

  • Maternal death

    42 days postpartum

  • The rate of repeated cesarean delivery

    At delivery

Study Arms (3)

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

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent
  • Women with mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

hair, blood

MeSH Terms

Conditions

HemorrhagePlacenta Accreta

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Yangyu Zhao, MD

CONTACT

13701118357zhaoyangyu@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of obstetrics

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 1, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2025

Last Updated

August 1, 2022

Record last verified: 2022-07