ClinicalTrials.gg
Status unknownNCT04096677Updated Sep 20, 2019

Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis in Patients With Post Cesarean Scar Defect

An observational study in Post Cesarean Scar Defect and Hysteroscopy, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 2 sites in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

The study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis.

Read the detailed description

Post cesarean scar defect (PCSD), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. The pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. These causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. Some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. At present, the causes and mechanisms of PCSD are not clear, diagnosis and treatment are not uniform. Surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. Hysteroscopic and transvaginal surgery to treating PCSD both are minimally invasive and feasible surgical approach. However, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with PCSD before.

02

Conditions studied

  • Post Cesarean Scar Defect
  • Hysteroscopy

Keywords

  • post cesarean scar defect
  • hysteroscopy
  • transvaginal intervention
  • endometrial receptive
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In context

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 161 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with post cesarean scar defect according to the transvaginal ultrasonography or hysteroscopy were recruited into present 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.

Inclusion criteria

  • Patients had a history of transverse lower uterine segment cesarean section;
  • Patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days)
  • Medication failed(contraceptive pills).
  • Sex hormone test is normal;
  • TVU or hysteroscopy showed a triangular or U-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix.

Exclusion criteria

Exclusion Criteria:

  • Irregular menstrual cycle before cesarean section
  • Previous placement of an intrauterine contraceptive device
  • Presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc
  • Existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid;
  • Coagulation dysfunction.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • hysteroscopy repair

    patients with post cesarean scar defect

    Procedure: hysteroscpy

  • transvaginal repair

    patients with post cesarean scar defect

Interventions

  • Procedurehysteroscpy
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What researchers measure

Primary outcomes

  1. Number of Participants with a less postoperative menstruation

    Follow-up carried out 6 months after the initial operation, using the following criteria to evaluate curative effect: Cure: menstrual duration was shortened to no more than 7 days and TVU showed no liquid dark area in scar of lower uterine segment; Improvement: menstrual duration was reduced by more than 2 days, but menstrual duration was still longer than 7days and TVU showed the liquid dark area in lower segment of uterus disappeared or narrowed. Failure: menstrual duration was reduced by less than 2 days or had no obvious change, and TVU showed the liquid dark area in lower segment of uterus did not narrow. Efficiency rate = cure rate + improvement rate.

    Time frame: 6 months

  2. Number of Participants being a pregnant

    Follow-up carried out 1 year after the initial operation, postoperative pregnancy with a history of infertility preoperatively

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • First affiliated hospital of SUN Yat-Sen University
    Guangzhou, Guangdong 510000, China
    • Yuqing Chen, MD · Contact
    Recruiting
  • The First Affiliated Hospital of SunYetSen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04096677
Responsible party
Yuqing Chen (Deputy chief physician, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Sep 20, 2019
Start date
Jan 1, 2017
Primary completion
Sep 30, 2019 (estimated)
Completion
Oct 30, 2019 (estimated)
Last update
Sep 20, 2019

Study contacts

Yuqing Chen, MD
Contact
fangchenyq@163.com
13724067575
Yuqing ChenMD
Contact
fangchenyq@163.com
13724067575
Yuqing Chen
study chair · The First Affiliated Hospital of SunYetSen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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