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Clinical Trials/CTRI/2021/11/037716
CTRI/2021/11/037716Not yet recruitingPhase 4

EPISCISSORS-60 VERSUS BUSCH EPISIOTOMY SCISSORS - A RANDOMISED CONTROLLED TRIAL COMPARING EPISIOTOMIES AND INCIDENCE OF OASIS

DRCHIPPY TESS MATHEW1 site in 1 country400 target enrollmentStarted: January 11, 2021Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
-Incidence of OASIS also noted

Study Overview

Brief Summary

Episiotomy is a routine procedure done during the second stage of labour, to reduce the incidence of perineal injuries. Episiotomy if given too medially or too laterally doesn’t serve the purpose and can increase the incidence of OASIS (Obstetric Anal Sphincter InjurieS).Episiotomy is most effective if the angle is 45 degree from the midline after suturing. To attain this angle the episiotomy scissors should cut at an angle of 60degree from the midline when the perineum is bulging during delivery. 

AIMS AND OBJECTIVES-) To compare the episiotomies using Episcissors-60 and Busch episiotomy scissors (length, distance from anal sphincter and angle of episiotomy) 2) To compare the incidence of OASIS with Episcissors-60 and Busch episiotomy scissors

Study designPatients are randomised into Busch group and Episcissors-60 group using the randomisation table. Episiotomy is given at crowning of head .The episiotomy is measured in the postnatal period for length, angle from midline and distance from anal sphincter. Any incidence of OASIS is noted.

                                          **Study population:**It comprises of 200 patients who were given a mediolateral episiotomy using Episcissors-60 at the crowning of the foetal head (group 1). Another group of 200 patients who were given a mediolateral episiotomy using Busch episiotomy scissorsat the crowning of the foetal head (group2).Randomisation is done using a randomisation table online.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Primigravida Cephalic presentation Normal/instrumental vaginal delivery Â.

Exclusion Criteria

  • •Multigravida Any patient not willing to participate are exempted Previous caesarean delivery malpresentation.

Outcomes

Primary Outcomes

-Incidence of OASIS also noted

Time Frame: -The episiotomy is measured in the immediate postnatal period | at BASELINE for length, angle from midline and distance from anal sphincter | -Incidence of OASIS also noted

-The episiotomy is measured in the postnatal period (IMMEDIATELY AFTER SUTURING-within half an hour of delivery) for length, angle from midline and distance from anal sphincter

Time Frame: -The episiotomy is measured in the immediate postnatal period | at BASELINE for length, angle from midline and distance from anal sphincter | -Incidence of OASIS also noted

Secondary Outcomes

  • Incidence of OASIS also noted(immediately after delivery within 10 minutes of placental delivery)

Investigators

Sponsor
DRCHIPPY TESS MATHEW
Sponsor Class
Other [self]

Study Sites (1)

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