- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379219
Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy
May 4, 2020 updated by: Maher elesawi kamel elesawi, Mansoura University
Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial
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).
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
56
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maher Elesawi Elgaly, M.D MRCOG
- Phone Number: +2 01016406182
- Email: mahereleswi@yahoo.com
Study Locations
-
-
Dakahliya
-
Mansoura, Dakahliya, Egypt
- Recruiting
- Mansoura University
-
Contact:
- Maher Elgaly, MD,MRCOG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: surgery
|
giving methotrexate at least 1 w week before surgery
Other Names:
|
ACTIVE_COMPARATOR: methotrexate before surgery
Valid consent
|
giving methotrexate at least 1 w week before surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated blood loss intraoperative
Time Frame: intraoperative blood loss
|
the amount of blood in soaked towels and vacuum aspiration
|
intraoperative blood loss
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
need further management
Time Frame: 1 month
|
1 month
|
• Rate of urological injury
Time Frame: immediatly and 1 week post operative
|
immediatly and 1 week post operative
|
• Rate of readmission, relaparotomy
Time Frame: with in 1 month
|
with in 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maher Elgaly, Mansoura University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2019
Primary Completion (ANTICIPATED)
August 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
May 4, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (ACTUAL)
May 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 4, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Cicatrix
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- R.19.10.639.R1.R2.R3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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