Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Methotrexate

About this trial

This is an interventional treatment trial for Cesarean Scar Pregnancy focused on measuring cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:•

Gestational age before 13 w
Past history of 1 or more CS
Presence of GS implanted on cesareans scar

Exclusion Criteria:

Presence of severe vaginal bleeding (emergency)
Previous history of uterine surgery other than CS
The whole mass is interior and the bulge is more in the cavity
Bleeding disorder
Patient not candidate for methotrexate (Positive fetal heart pulsation,
Patient refuse to participate in the study

Sites / Locations

Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

surgery

methotrexate before surgery

Arm Description

Valid consent Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) Laparotomy transverse incision (pfannenstiel incision) Exploration of the abdominal cavity Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. Surgical repair of the uterine incision, and the abdomen

Valid consent patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery. Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) Laparotomy transverse incision (pfannenstiel incision) Exploration of the abdominal cavity Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. Surgical repair of the uterine incision, and the abdomen

Outcomes

Primary Outcome Measures

Estimated blood loss intraoperative

the amount of blood in soaked towels and vacuum aspiration

Secondary Outcome Measures

need further management

• Rate of urological injury

• Rate of readmission, relaparotomy

Full Information

NCT ID

NCT04379219

First Posted

May 4, 2020

Last Updated

May 4, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04379219

Brief Title

Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Official Title

Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez & Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).

Detailed Description

This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Scar Pregnancy

Keywords

cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surgery

Arm Type

Active Comparator

Arm Description

Valid consent Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) Laparotomy transverse incision (pfannenstiel incision) Exploration of the abdominal cavity Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. Surgical repair of the uterine incision, and the abdomen

Arm Title

methotrexate before surgery

Arm Type

Active Comparator

Arm Description

Valid consent patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery. Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) Laparotomy transverse incision (pfannenstiel incision) Exploration of the abdominal cavity Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. Surgical repair of the uterine incision, and the abdomen

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Other Intervention Name(s)

unitrexate

Intervention Description

giving methotrexate at least 1 w week before surgery

Primary Outcome Measure Information:

Title

Estimated blood loss intraoperative

Description

the amount of blood in soaked towels and vacuum aspiration

Time Frame

intraoperative blood loss

Secondary Outcome Measure Information:

Title

need further management

Time Frame

1 month

Title

• Rate of urological injury

Time Frame

immediatly and 1 week post operative

Title

• Rate of readmission, relaparotomy

Time Frame

with in 1 month

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:• Gestational age before 13 w Past history of 1 or more CS Presence of GS implanted on cesareans scar Exclusion Criteria: Presence of severe vaginal bleeding (emergency) Previous history of uterine surgery other than CS The whole mass is interior and the bulge is more in the cavity Bleeding disorder Patient not candidate for methotrexate (Positive fetal heart pulsation, Patient refuse to participate in the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maher Elesawi Elgaly, M.D MRCOG

Phone

+2 01016406182

Email

mahereleswi@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maher Elgaly

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University

City

Mansoura

State/Province

Dakahliya

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maher Elgaly, MD,MRCOG

12. IPD Sharing Statement

Plan to Share IPD

Yes

Cesarean Scar Pregnancy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial