Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery

NCT04205292 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-10-08

No results posted yet for this study

Summary

Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean section.

A recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of options represents a real challenge for the health care provider. The choice may be made among expectant management, medical treatment, local treatment and surgical approach, also combined together. There is insufficient evidence to recommend any one specific intervention over another for caesarean scar pregnancy. Future studies are needed to define the optimal management of pregnancy for caesarean section scars.

Thus, we aim to compare the success rate of two different treatment of CSP: the medical management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D\&E) compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.

Conditions

  • Scar; Previous Cesarean Section

Interventions

PROCEDURE

hysteroscopic

Women in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2021-12-15
Completion
2022-01-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205292 on ClinicalTrials.gov