NCT01723605

Brief Summary

Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

November 4, 2012

Last Update Submit

December 28, 2013

Conditions

Complications; Cesarean Section

Keywords

insitu repairintestinal motility

Outcome Measures

Primary Outcomes (1)

  • Bowel movement

    Regain of bowel movement

    12 hours

Secondary Outcomes (1)

  • Surgery duration

    2 hours

Study Arms (2)

insitu repair

EXPERIMENTAL

insitu repair of the uterine incision during caeserean section

Procedure: insitu repair

exteriorisation of the uretus

ACTIVE COMPARATOR

uterine closure during caeserian section with exteriorisation of the uterus

Procedure: exteriorisation of the uterus

Interventions

insitu repairPROCEDURE

closure of the uterine incision while the uterus initu

Also known as: repair insitu
insitu repair
exteriorisation of the uterusPROCEDURE

uterine closure while the uterus is exteriorised

Also known as: uterine closure with exteriorisation of the uterus
exteriorisation of the uretus

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women

You may not qualify if:

  • liver disease
  • kidney disease
  • bleeding tendency
  • abnormal placentation
  • preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, 12211, Egypt

Location

Related Publications (1)

  • El-Khayat W, Elsharkawi M, Hassan A. A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery. Int J Gynaecol Obstet. 2014 Nov;127(2):163-6. doi: 10.1016/j.ijgo.2014.05.004. Epub 2014 Jun 19.

    PMID: 25005057DERIVED

Study Officials

  • Waleed El-khayat

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

November 4, 2012

First Posted

November 8, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

EG(1)