NCT02144805

Brief Summary

The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable pregnancy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

4.9 years

First QC Date

May 20, 2014

Last Update Submit

May 5, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Myometrial thickness

    Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound

    5 months

Study Arms (2)

Suturing in a single layer

ACTIVE COMPARATOR

The technique used for single layer to close the uterine incision following cesarean sectio

Procedure: Suturing in a single layer

Suturing in two layer

ACTIVE COMPARATOR

The technique used for two layer technie to close the uterine incision following cesarean sectio

Procedure: Suturing in two layer

Interventions

Suturing in a single layerPROCEDURE

The procedure define the use of one single suture for closure of the uterine incision following cesarean section.

Suturing in a single layer
Suturing in two layerPROCEDURE

The procedure define the use of two sutures for closing the uterine incision following cesarean section

Suturing in two layer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women submitted to cesarean sectio

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

Roskilde, Roskilde, 4000, Denmark

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Gitte Bennich, consultant

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

DK(1)