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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03270605
Other study ID # R/17.04.71
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2019

Study information

Verified date August 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 41 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Myomectomy
Surgical removal of uterine fibroid

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Outcome

Type Measure Description Time frame Safety issue
Primary Deficit in hemoglobin level Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl) 24 hours
Secondary Operative time Time to complete the procedure 3 hours
Secondary Postoperative hospital stay period Time from the end of operation to discharge from hospital 7 days
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