NCT07095647

Brief Summary

The study investigates the feasibility, safety, and outcomes of a simultaneous surgical approach for cesarean scar ectopic pregnancy (CSEP). CSEP is a prevalent and serious form of ectopic pregnancy requiring swift intervention. The research explores using hysteroscopy and laparoscopy concurrently to manage the CSEP and repair the uterine scar defect. The procedure involved hysteroscopic-guided evacuation and a double-layer laparoscopic repair, followed by a second hysteroscopy to confirm the repair's effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.

    The proportion of patients who restored their normal endometrial metrics and removed any uterine scars during the study, reflecting the effectiveness of the applied Hystreoscopy regimens.

    6~7 months

Study Arms (1)

Cesarean Scar Ectopic Pregnancy Patients (CSEP)

OTHER

Patients presenting pregnant with a history of at least one previous Cesarean Section, and Transvaginal ultrasound documentation of Cesarean Scar Ectopic Pregnancy.

Procedure: Hysteroscopy

Interventions

HysteroscopyPROCEDURE

Hysteroscopic-guided suction evacuation and double-layer laparoscopic repair of the niche were performed concomitantly and followed by second-look hysteroscopy to ensure the competence of the repair.

Cesarean Scar Ectopic Pregnancy Patients (CSEP)

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with positive clinical and lab pregnancy diagnosis;
  • Patients with history of at least one previous Cesarean section;
  • Patients with Transvaginal ultrasound documenting Cesarean scar ectopic Pregnancy;

You may not qualify if:

  • Patients with were extensive adhesions between the mass and the urinary bladder on MRI;
  • Patients with myomas, polyps, endometrial hyperplasia, and cancers of the cervix or endometrium;
  • Patients with a body mass index (BMI) of \>35kg/m2;
  • Patients with previous abdominal surgeries with possible difficulties during laparoscopy;
  • Patients with menstrual irregularities, or coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University

Banhā, El- Qalyobia, 13511, Egypt

Location

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics & Gynecology, Faculty of Medicine

Study Record Dates

First Submitted

July 30, 2025

First Posted

July 31, 2025

Study Start

October 1, 2024

Primary Completion

April 15, 2025

Study Completion

May 20, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations