Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees (IAME)
Recruitment status was Recruiting
The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees|
- and fourth degree perineal tears. [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: incision angle of 60 degrees
episiotomy incision angle will be defined as 60 degree as measured before cutting.
incision angle of episiotomy will be 40 degree before cutting.
Experimental: incision angle 40 degree episiotomy
incision angle of episiotomy will be defined as 40 degree as measured before cutting.
incision angle of episiotomy will be 60 degrees.
Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01930721
|Contact: shafik adel, MDfirstname.lastname@example.org|
|Ain Shams Unversity Hospitals||Recruiting|
|Contact: adel shafik, lecturer 01005223586 email@example.com|
|Principal Investigator: malka ameen|
|Principal Investigator:||ADEL SH SLAH EL-DIN, MD||LECTURER|