Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04379219

Enrollment

Registered

2020-05-07

Start date

2019-12-01

Completion date

2020-12-31

Last updated

2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Scar Pregnancy

Keywords

cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy

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

Interventions

DRUGMethotrexate

giving methotrexate at least 1 w week before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
Estimated blood loss intraoperative	intraoperative blood loss	the amount of blood in soaked towels and vacuum aspiration

Secondary

Measure	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

Countries

Egypt

Contacts

Primary ContactMaher Elesawi Elgaly, M.D MRCOG

mahereleswi@yahoo.com+2 01016406182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026