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

This study is currently recruiting participants.

Verified February 2013 by Region Skane

Sponsor:

Information provided by (Responsible Party):

Region Skane

ClinicalTrials.gov Identifier:

NCT01091181

First received: March 19, 2010

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 19, 2010
Last Updated Date	February 12, 2013
Start Date ^ICMJE	October 2009
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2010)	Large defect in hysterotomy scar after caesarean [ Time Frame: 6- 9 months after the Cesarean ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01091181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 22, 2010)	Uterine dehiscence or rupture in the subsequent pregnancy [ Time Frame: in the subsequent pregnancy ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
Official Title ^ICMJE	The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Scars
Intervention ^ICMJE	Procedure: Hysterotomy at cesarean hysterotomy is performed 2 cm above or below the bladder insertion
Study Arm (s)	Experimental: 2 cm above At cesarean the hysterotomy is made 2 cm above the bladder insertion Intervention: Procedure: Hysterotomy 2 cm below at cesarean hysterotomy is done 2 cm below the bladder insertion Intervention: Procedure: Hysterotomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	200
Completion Date	Not Provided
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: No previous caesarean 5 cm cervical dilatation at least 18 years old
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01091181
Other Study ID Numbers ^ICMJE	2-valentin
Has Data Monitoring Committee	No
Responsible Party	Region Skane
Study Sponsor ^ICMJE	Region Skane
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Region Skane
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top