The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar

This study is currently recruiting participants.
Verified October 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01091181
First received: March 19, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

Women who are to undergo their first Cesarean and have cervical dilatation 5 cm or more are randomized to having the hysterotomy 2 cm below or above the bladder insertion on the uterus. They are followed up with a transvaginal scan of the uterus 6 - 9 months after the Cesarean to assess the appearance of the Cesarean scar in the uterus.


Condition Intervention
Scars
Procedure: Hysterotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Large defect in hysterotomy scar after caesarean [ Time Frame: 6- 9 months after the Cesarean ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uterine dehiscence or rupture in the subsequent pregnancy [ Time Frame: in the subsequent pregnancy ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 cm above
At cesarean the hysterotomy is made 2 cm above the bladder insertion
Procedure: Hysterotomy
at cesarean hysterotomy is performed 2 cm above or below the bladder insertion
2 cm below
at cesarean hysterotomy is done 2 cm below the bladder insertion
Procedure: Hysterotomy
at cesarean hysterotomy is performed 2 cm above or below the bladder insertion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No previous caesarean
  • 5 cm cervical dilatation at least 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091181

Locations
Sweden
Skåne University Hospital Malmö Recruiting
Malmö, Sweden, Se 20502
Contact: Lil Valentin, MD, PhD    +4640331000 ext 2149    lil.valentin@med.lu.se   
Principal Investigator: Lil Valentin, MD, PhD         
Sponsors and Collaborators
Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01091181     History of Changes
Other Study ID Numbers: 2-valentin
Study First Received: March 19, 2010
Last Updated: October 25, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Caesarean

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014