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

Primary Purpose

Scar; Previous Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hysteroscopic
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar; Previous Cesarean Section

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Singleton gestations;
  • 18 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Gabriele SacconeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dilatation and Evacuation (D&E)

hysteroscopic surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

success rate of treatment protocols,
defined as no further treatment required until the complete resolution of the scar pregnancy.

Secondary Outcome Measures

Further treatment required until the complete resolution of the scar pregnancy
Further treatment required until the complete resolution of the CSP (repeat administration of methotrexate (MTX) and/or other surgical procedures),
histerectomy
histerectomy
Maternal transfusion
Maternal transfusion

Full Information

First Posted
December 15, 2019
Last Updated
October 7, 2020
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT04205292
Brief Title
Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
Official Title
Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Since the first description of cesarean scar pregnancy in 1978, its frequency has increased dramatically due to the significant increase in the percentage of cesarean section and development of transvaginal (TV) ultrasonography (US). The overall incidence of CSP is 1 in 1,800 to 1 in 2,200 pregnancies, it means 0.05-0.04% of all pregnancies. In women after a cesarean section, the frequency of CSP is approximately 0.15%, which constitutes 6.1% of all ectopic pregnancies in patients after at least one cesarean operation. The risk factors that favour implantation in the CS scar are not well understood; therefore, there are no guidelines for the practicing physicians to determine the women at risk. Uterine surgery, anomalous healing of the scar, previous preterm CS without labour or a term elective CS, breech presentation at previous CS short intervals between the CSP and last pregnancy, last pregnancy ended with abortion may be some of the risk factors for CSP. Although the 15% of CSPs remain undiagnosed, developed egographic techniques and several new US signs of CSP invasiveness are allowing ever better diagnoses. Cali et al. tested the hypothesis the relationship between the gestational sac of the CSP, previous caesarean scar and the anterior uterine wall can be used to predict the evolution of these cases. In order to do this, they propose a new sonographic sign, the "cross-over sign" (COS) . This echographic sign is reflected in the clinical presentation of the CSP, so we can divide the patients into two different groups: type I "endogenic type" characterized by the COS2 insertion, ance type II "exogenic type" characterized by COS1 insertion, the latter with worse outcomes in term of maternal morbidity and mortality. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar; Previous Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dilatation and Evacuation (D&E)
Arm Type
Active Comparator
Arm Description
Women in this group will receive an in-patient treatment with Dilatation and Evacuation (D&E) after two doses of Methotrexate .
Arm Title
hysteroscopic surgery
Arm Type
Experimental
Arm Description
Women in this group will receive hysteroscopic surgery after two doses of Methotrexate .
Intervention Type
Procedure
Intervention Name(s)
hysteroscopic
Intervention Description
Women in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance
Primary Outcome Measure Information:
Title
success rate of treatment protocols,
Description
defined as no further treatment required until the complete resolution of the scar pregnancy.
Time Frame
resolution of scar pregnancy, day 7
Secondary Outcome Measure Information:
Title
Further treatment required until the complete resolution of the scar pregnancy
Description
Further treatment required until the complete resolution of the CSP (repeat administration of methotrexate (MTX) and/or other surgical procedures),
Time Frame
resolution of scar pregnancy, day 7
Title
histerectomy
Description
histerectomy
Time Frame
resolution of scar pregnancy, day 7
Title
Maternal transfusion
Description
Maternal transfusion
Time Frame
resolution of scar pregnancy, day 7

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Singleton gestations; 18 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Saccone, MD
Phone
0817461111
Email
gabriele.saccone@unina.it
Facility Information:
Facility Name
Gabriele Saccone
City
Napoli
ZIP/Postal Code
80129
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone
Phone
3394685179
Email
gabriele.saccone@libero.it

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan

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

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