NCT03095014

Brief Summary

Cesarean Myomectomy, safety and effect on uterine cavity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

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, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

5.9 years

First QC Date

March 16, 2017

Last Update Submit

March 22, 2017

Conditions

Myomectomy

Outcome Measures

Primary Outcomes (1)

  • Mean change in Haemoglobin in gm/dl

    pre-operative Haemoglobin minus post-operative Haemoglobin level

    24 hours

Secondary Outcomes (2)

  • Duration of operation in hours

    2 hours

  • intrauterine adesion adhesions

    3 months

Study Arms (2)

Cesarean Myomectomy

EXPERIMENTAL

Myomectomy plus Cesarean section

Procedure: Cesarean Myomectomy

Cesarean section

ACTIVE COMPARATOR

Cesarean section only

Procedure: Cesarean section

Interventions

Cesarean MyomectomyPROCEDURE

Myomectomy was done during Cesarean section

Cesarean Myomectomy
Cesarean sectionPROCEDURE

Cesarean delivery

Cesarean section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant
  • full term
  • had uterine myoma

You may not qualify if:

  • history of coagulation disorder
  • antepartum hemorrhage
  • previous myomectomy
  • where additional operative procedures were performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • ibrahim A el sharkwy

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cesarean Myomectomy
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 29, 2017

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share