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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Region Skane.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091181
First Posted: March 23, 2010
Last Update Posted: October 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Region Skane
  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
Intervention Model: Factorial Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Uterine dehiscence or rupture in the subsequent pregnancy [ Time Frame: in the subsequent pregnancy ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01091181     History of Changes
Other Study ID Numbers: 2-valentin
First Submitted: March 19, 2010
First Posted: March 23, 2010
Last Update Posted: October 28, 2013
Last Verified: October 2013

Keywords provided by Region Skane:
Caesarean