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Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

NCT ID: NCT01930721

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstetric Labor Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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incision angle of 60 degrees

episiotomy incision angle will be defined as 60 degree as measured before cutting.

Group Type EXPERIMENTAL

episiotomy

Intervention Type PROCEDURE

incision angle of episiotomy will be 40 degree before cutting.

incision angle 40 degree episiotomy

incision angle of episiotomy will be defined as 40 degree as measured before cutting.

Group Type EXPERIMENTAL

episiotomy

Intervention Type PROCEDURE

incision angle of episiotomy will be 60 degrees.

Interventions

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episiotomy

incision angle of episiotomy will be 60 degrees.

Intervention Type PROCEDURE

episiotomy

incision angle of episiotomy will be 40 degree before cutting.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Primigravida with singleton pregnancy presenting by vertex.
2. Gestational age \> 37 weeks
3. No instrumental delivery.
4. No fetal distress or any emergency

Exclusion Criteria

1. Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
2. Inability to understand the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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malka amen

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ADEL SH SLAH EL-DIN, MD

Role: PRINCIPAL_INVESTIGATOR

LECTURER

Locations

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Ain Shams Unversity Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shafik adel, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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adel shafik, lecturer

Role: primary

References

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El-Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. J Obstet Gynaecol Res. 2014 Jul;40(7):1877-82. doi: 10.1111/jog.12432.

Reference Type DERIVED
PMID: 25056465 (View on PubMed)

Other Identifiers

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incision angle of mediolateral

Identifier Type: -

Identifier Source: org_study_id