NCT04379219

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 4, 2020

Last Update Submit

May 4, 2020

Conditions

Cesarean Scar Pregnancy

Keywords

cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy

Outcome Measures

Primary Outcomes (1)

  • Estimated blood loss intraoperative

    the amount of blood in soaked towels and vacuum aspiration

    intraoperative blood loss

Secondary Outcomes (3)

  • need further management

    1 month

  • • Rate of urological injury

    immediatly and 1 week post operative

  • • Rate of readmission, relaparotomy

    with in 1 month

Study Arms (2)

surgery

ACTIVE COMPARATOR

* 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

methotrexate before surgery

ACTIVE COMPARATOR

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

Interventions

MethotrexateDRUG

giving methotrexate at least 1 w week before surgery

Also known as: unitrexate
methotrexate before surgerysurgery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age before 13 w
  • Past history of 1 or more CS
  • Presence of GS implanted on cesareans scar

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahliya, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, SpontaneousPregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Maher Elgaly

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maher Elesawi Elgaly, M.D MRCOG

CONTACT

+2 01016406182mahereleswi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetric and gynecology

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

December 1, 2019

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations

EG(1)