Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Cesarean Scar Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04379219
• Other study ID #: R.19.10.639.R1.R2.R3
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: Maher Elesawi Elgaly, M.D MRCOG
• Phone: +2 01016406182
• Email: mahereleswi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Scar Pregnancy
• Cicatrix

Intervention

Drug:
• Methotrexate
giving methotrexate at least 1 w week before surgery

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss intraoperative	the amount of blood in soaked towels and vacuum aspiration	intraoperative blood loss
Secondary	need further management		1 month
Secondary	• Rate of urological injury		immediatly and 1 week post operative
Secondary	• Rate of readmission, relaparotomy		with in 1 month