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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
March 19, 2010
March 23, 2010
October 28, 2013
October 2009
December 2014   (Final data collection date for primary outcome measure)
Large defect in hysterotomy scar after caesarean [ Time Frame: 6- 9 months after the Cesarean ]
Same as current
Complete list of historical versions of study NCT01091181 on ClinicalTrials.gov Archive Site
Uterine dehiscence or rupture in the subsequent pregnancy [ Time Frame: in the subsequent pregnancy ]
Same as current
Not Provided
Not Provided
 
The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Scars
Procedure: Hysterotomy
at cesarean hysterotomy is performed 2 cm above or below the bladder insertion
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Not Provided
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • No previous caesarean
  • 5 cm cervical dilatation at least 18 years old
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01091181
2-valentin
No
Not Provided
Not Provided
Region Skane
Region Skane
Not Provided
Not Provided
Region Skane
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP