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

March 19, 2010
October 25, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.
 
Recruiting
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
Female
18 Years and older
Yes
Sweden
 
NCT01091181
2-valentin
No
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