Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Mansoura University

Status and phase: Unknown; Phase 4

Conditions: Cesarean Scar Pregnancy

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04379219

R.19.10.639.R1.R2.R3

Details and patient eligibility

About

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).

Full 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

Enrollment: 56 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

surgery

Active Comparator group

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

Treatment:

Drug: Methotrexate

methotrexate before surgery

Active Comparator group

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

Treatment:

Drug: Methotrexate