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Myomectomy During Cesarean Section Is This Aright Decision

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT04390659
Collaborator
(none)
45
Enrollment
61
Actual Duration (Months)

Study Details

Study Description

Brief Summary

myomectomy was done during cesarean section

Condition or Disease Intervention/Treatment Phase
  • Procedure: myomectomy

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Myomectomy During Cesarean Section,Is This Aright Decision
Actual Study Start Date :
Aug 15, 2014
Actual Primary Completion Date :
Mar 20, 2019
Actual Study Completion Date :
Sep 15, 2019

Outcome Measures

Primary Outcome Measures

  1. difficulty of cesarean myomectomy [during the procedure/surgery"]

    according to the site and type of myoma

Secondary Outcome Measures

  1. 4concentrations of hemoglobin [during the procedure]

    intra operative bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Benha University

Investigators

  • Principal Investigator: khalid salama, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
khalid mohammed salama, clinical professor, Benha University
ClinicalTrials.gov Identifier:
NCT04390659
Other Study ID Numbers:
  • khalid7
First Posted:
May 15, 2020
Last Update Posted:
May 15, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obstetric Labor, Premature

Study Results

No Results Posted as of May 15, 2020