Myomectomy During CS: A Retrospective Cohort Study
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT03270605
Collaborator
(none)
178
60
Study Details
Study Description
Brief Summary
To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
178 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Myomectomy During Cesarean Section: A Retrospective Cohort Study
Actual Study Start Date
:
Jan 1, 2015
Actual Primary Completion Date
:
Dec 31, 2019
Actual Study Completion Date
:
Dec 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CS with myomectomy Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS |
Procedure: Myomectomy
Surgical removal of uterine fibroid
|
| CS without myomectomy Women having uterine myoma with pregnancy and delivered by CS without myomectomy |
Outcome Measures
Primary Outcome Measures
- Deficit in hemoglobin level [24 hours]
Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)
Secondary Outcome Measures
- Operative time [3 hours]
Time to complete the procedure
- Postoperative hospital stay period [7 days]
Time from the end of operation to discharge from hospital
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 41 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery
Exclusion Criteria:
-
Antepartum hemorrhage
-
Blood diseases or bleeding tendencies.
-
Medical conditions complicating pregnancy.
-
Performed another surgical procedure at CS other than myomectomy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
- Principal Investigator: Waleed El-refaie, MD, Port Said University
- Study Director: Mohamed Hassan, MD, Mansoura University
- Study Chair: Mohamed S Abdelhafez, MD, Mansoura University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT03270605
Other Study ID Numbers:
- R/17.04.71
First Posted:
Sep 1, 2017
Last Update Posted:
Sep 1, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: