NCT01519440

Brief Summary

The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

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

March 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

January 24, 2012

Last Update Submit

October 21, 2012

Conditions

Disruption of Uterine Incision After Cesarean Section

Keywords

unintended extensionbluntsharpmaternal blood loss

Outcome Measures

Primary Outcomes (1)

  • unintended extension of uterine incision

    during the operation

Secondary Outcomes (1)

  • intraoperative maternal blood loss

    after 48 hours than operation

Study Arms (2)

blunt

Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad.

sharp

Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

elective cesarean delivery cases

You may qualify if:

  • Term pregnancy(\> 38 weeks of gestation)
  • Required elective cesarean delivery
  • maternal age between 18-40 years

You may not qualify if:

  • Required emergency cesarean delivery
  • Abnormal presentation
  • Planned cesarean hysterectomy
  • History of low segment vertical uterine incision
  • History of classical upper segment uterine incision
  • multiple pregnancy
  • cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
  • Grand multiparity(parity\>5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Bakırköy Maternal and Childrens Hospital

Istanbul, Bakırköy, 34274, Turkey (Türkiye)

Location

Related Publications (1)

  • Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52. doi: 10.1111/j.1471-0528.2002.01296.x.

    PMID: 12013167RESULT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

TU(1)