NCT03270605

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

January 1, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

5 years

First QC Date

August 31, 2017

Last Update Submit

August 28, 2020

Conditions

Cesarean SectionUterine Fibroid

Outcome Measures

Primary Outcomes (1)

  • Deficit in hemoglobin level

    Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)

    24 hours

Secondary Outcomes (2)

  • Operative time

    3 hours

  • Postoperative hospital stay period

    7 days

Study Arms (2)

CS with myomectomy

Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS

Procedure: Myomectomy

CS without myomectomy

Women having uterine myoma with pregnancy and delivered by CS without myomectomy

Interventions

MyomectomyPROCEDURE

Surgical removal of uterine fibroid

CS with myomectomy

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with uterine fibroid during the index pregnancy

You may qualify if:

  • Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery

You may not qualify if:

  • Antepartum hemorrhage
  • Blood diseases or bleeding tendencies.
  • Medical conditions complicating pregnancy.
  • Performed another surgical procedure at CS other than myomectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Waleed El-refaie, MD

    Port Said University

    PRINCIPAL INVESTIGATOR

  • Mohamed Hassan, MD

    Mansoura University

    STUDY DIRECTOR

  • Mohamed S Abdelhafez, MD

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

January 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 1, 2020

Record last verified: 2020-08