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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014