CClinicalTrials.gg
CompletedNCT03095014Updated Mar 29, 2017

Myomectomy During Cesarean Section

A Phase 1 interventional study of Cesarean Myomectomy and Cesarean section in Myomectomy, sponsored by Zagazig University. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Zagazig University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Jan 2010, registered Mar 2017).
Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Cesarean Myomectomy, safety and effect on uterine cavity.

Read the detailed description

this study aims to compare between women who underwent Cesarean Myomectomy and those who underwent Cesarean section only regarding the procedure safety and whether uterine cavity was affected later on.

02

Conditions studied

  • Myomectomy
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnant
  • full term
  • had uterine myoma

Exclusion criteria

Exclusion Criteria:

  • history of coagulation disorder
  • antepartum hemorrhage
  • previous myomectomy
  • where additional operative procedures were performed
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Cesarean Myomectomy

    Myomectomy plus Cesarean section

    Procedure: Cesarean Myomectomy

  • Active comparator
    Cesarean section

    Cesarean section only

    Procedure: Cesarean section

Interventions

  • ProcedureCesarean Myomectomy

    Myomectomy was done during Cesarean section

  • ProcedureCesarean section

    Cesarean delivery

06

What researchers measure

Primary outcomes

  1. Mean change in Haemoglobin in gm/dl

    pre-operative Haemoglobin minus post-operative Haemoglobin level

    Time frame: 24 hours

Secondary outcomes

  1. Duration of operation in hours

    time to complete the procedure

    Time frame: 2 hours

  2. intrauterine adesion adhesions

    presence of uterine cavity adhesions

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03095014
Lead sponsor
Zagazig University
Responsible party
IBRAHIM ABD ELGAFOR (assistant professor, Zagazig University) — Principal investigator
First posted
Mar 29, 2017
Start date
Jan 2010
Primary completion
Dec 2015
Completion
Oct 2016
Last update
Mar 29, 2017

Study contacts

ibrahim A el sharkwy
principal investigator · Zagazig University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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