NCT04390659

Brief Summary

myomectomy was done during cesarean section

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

4.6 years

First QC Date

April 29, 2020

Last Update Submit

May 13, 2020

Conditions

Obstetric Labor, Premature

Outcome Measures

Primary Outcomes (1)

  • difficulty of cesarean myomectomy

    according to the site and type of myoma

    during the procedure/surgery"

Secondary Outcomes (1)

  • 4concentrations of hemoglobin

    during the procedure

Interventions

myomectomyPROCEDURE

The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

c s with uterine myoma

You may qualify if:

  • women with diagnosed uterine myoma prior to pregnancy
  • needed cesarean sections for various indications.
  • Women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications.
  • Women with myoma diagnosed incidentally during labour.

You may not qualify if:

  • Refusal of the women at any time before and during the operations.
  • Cervical myoma.
  • Atonic uterus after delivery of the baby.
  • Women with bleeding disorders due to medical or obstetric causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.

    PMID: 11756390RESULT

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • khalid salama

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 15, 2020

Study Start

August 15, 2014

Primary Completion

March 20, 2019

Study Completion

September 15, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

master sheet