Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cesarean Scar Pregnancy

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery<br>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 | Drug: Methotrexate<br>* giving methotrexate at least 1 w week before surgery<br>* Other names: unitrexate;|
| Active Comparator: methotrexate before surgery<br>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 | Drug: Methotrexate<br>* giving methotrexate at least 1 w week before surgery<br>* Other names: unitrexate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss intraoperative | the amount of blood in soaked towels and vacuum aspiration | intraoperative blood loss | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need further management |  | 1 month | 
| • Rate of urological injury |  | immediatly and 1 week post operative | 
| • Rate of readmission, relaparotomy |  | with in 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy