Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

NCT ID: NCT04379219

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-12-31

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

Conditions

Cesarean Scar Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

surgery

• 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

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

giving methotrexate at least 1 w week before surgery

methotrexate before surgery

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

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

giving methotrexate at least 1 w week before surgery

Interventions

Methotrexate

giving methotrexate at least 1 w week before surgery

Intervention Type: DRUG

Other Intervention Names

unitrexate

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Maher elesawi kamel elesawi

Lecturer of obstetric and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maher Elgaly

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura University

Al Mansurah, Dakahliya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maher Elesawi Elgaly, M.D MRCOG

Role: CONTACT

mahereleswi@yahoo.com

+2 01016406182

Facility Contacts

Maher Elgaly, MD,MRCOG

Role: primary

Other Identifiers

R.19.10.639.R1.R2.R3

Identifier Type: -

Identifier Source: org_study_id