NCT04307524

Brief Summary

Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management.

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
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2

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

February 21, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 21, 2020

Last Update Submit

March 11, 2020

Conditions

Cesarean Section Complications

Keywords

cesarean scar niche

Outcome Measures

Primary Outcomes (1)

  • post-menstrual spotting

    number of days of post-menstrual spotting "spotting or bleeding after 8 days of menstruation whatever the amount

    6 month after intervention

Secondary Outcomes (2)

  • menstrual related pain

    6 month after intervention

  • infertility

    6 month after intervention

Study Arms (2)

laparoscopic repair

EXPERIMENTAL

suture repair of cesarean scar niche using laparoscopy

Procedure: laparoscopic repair

medical treatment

ACTIVE COMPARATOR

conservative management

Drug: medical treatment in the form of combined hormonal contraception

Interventions

laparoscopic repairPROCEDURE

laparoscopic suture repair of cesarean scar niche

laparoscopic repair
medical treatment in the form of combined hormonal contraceptionDRUG

patient will receive for three months daily without interruption, no pill-free interval drug names is "Genera" BAYERhealthcare

medical treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of cesarean section.
  • Postmenstrual and/or intermenstrual spotting.
  • Cesarean scar niche of at least 2 mm in depth diagnosed by saline infusion sonography

You may not qualify if:

  • pregnancy
  • Uterine anomalies
  • Hysterotomy.
  • history Placenta previa and MAP
  • Upper segment incision, Vertical uterine incision
  • submucosal fibroids
  • adenomyosis.
  • History atypical endometrial cells, cervical dysplasia,
  • cervical or pelvic infection.
  • Irregular cycle.
  • lactation amenorrhea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
computer-generated sequence
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist & Assistant Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

February 21, 2020

First Posted

March 13, 2020

Study Start

March 15, 2020

Primary Completion

March 15, 2021

Study Completion

March 30, 2021

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share