NCT04205292

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

December 15, 2019

Last Update Submit

October 7, 2020

Conditions

Scar; Previous Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • success rate of treatment protocols,

    defined as no further treatment required until the complete resolution of the scar pregnancy.

    resolution of scar pregnancy, day 7

Secondary Outcomes (3)

  • Further treatment required until the complete resolution of the scar pregnancy

    resolution of scar pregnancy, day 7

  • histerectomy

    resolution of scar pregnancy, day 7

  • Maternal transfusion

    resolution of scar pregnancy, day 7

Study Arms (2)

Dilatation and Evacuation (D&E)

ACTIVE COMPARATOR

Women in this group will receive an in-patient treatment with Dilatation and Evacuation (D\&E) after two doses of Methotrexate .

Procedure: hysteroscopic

hysteroscopic surgery

EXPERIMENTAL

Women in this group will receive hysteroscopic surgery after two doses of Methotrexate .

Procedure: hysteroscopic

Interventions

hysteroscopicPROCEDURE

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

Dilatation and Evacuation (D&E)hysteroscopic surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton gestations;
  • years to 50 years;
  • Diagnosis of CSP;
  • Gestational age ≤ 8 weeks and 6 days;
  • Therapy with systemic Methotrexate 2-dose;
  • Thickness of myometrial layer ≥2 mm.

You may not qualify if:

  • Diagnosis of cervical pregnancy, aborting intrauterine pregnancy, or any other anomalous implantation site;
  • Gestational age \>8 weeks and 6 days;
  • Heavy vaginal bleeding at the time of randomization;
  • Women who did not received Methotrexate or received a single dose or a local dose;
  • Thickness of myometrial layer \<2 mm
  • Women who are unconscious, ill, mentally handicapped;
  • Women under the age of 18 years or over the age of 50 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

RECRUITING

Related Publications (1)

  • Di Spiezio Sardo A, Zizolfi B, Saccone G, Ferrara C, Sglavo G, De Angelis MC, Mastantuoni E, Bifulco G. Hysteroscopic resection vs ultrasound-guided dilation and evacuation for treatment of cesarean scar ectopic pregnancy: a randomized clinical trial. Am J Obstet Gynecol. 2023 Oct;229(4):437.e1-437.e7. doi: 10.1016/j.ajog.2023.04.038. Epub 2023 May 3.

    PMID: 37142075DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Gabriele Saccone, MD

CONTACT

0817461111gabriele.saccone@unina.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 19, 2019

Study Start

December 23, 2019

Primary Completion

December 15, 2021

Study Completion

January 15, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

no plan

Locations

IT(1)