Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Phase 4

• Conditions: Cesarean Scar Pregnancy
• Interventions: Drug: Methotrexate

• Registration Number: NCT04379219
• Lead Sponsor: Mansoura University

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

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methotrexate before surgery	Methotrexate	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
surgery	Methotrexate	* 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

Primary Outcome Measures

Name	Time	Method
Estimated blood loss intraoperative	intraoperative blood loss	the amount of blood in soaked towels and vacuum aspiration

Secondary Outcome Measures

Name	Time	Method
need further management	1 month
• Rate of urological injury	immediatly and 1 week post operative
• Rate of readmission, relaparotomy	with in 1 month

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahliya, Egypt