NCT02717676

Brief Summary

Previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. Episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. So, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

March 13, 2016

Last Update Submit

August 17, 2019

Conditions

Normal Labor

Outcome Measures

Primary Outcomes (1)

  • Rate of third and forth degree perineal tears

    intraoperative

Secondary Outcomes (1)

  • Rate of first and second degree perineal tears

    intraoperative

Study Arms (2)

Group A

EXPERIMENTAL

Episiotomy

Procedure: Episiotomy

Group B

NO INTERVENTION

no episiotomy

Interventions

EpisiotomyPROCEDURE

episiotomy will be done after crowning of the fetal head

Group A

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Multipara
  • Singleton pregnancy
  • Full-term (37- 40 weeks)
  • Average size fetus (2500-4000 gm)
  • Cephalic-vertex presentation
  • Spontaneous onset of labor
  • No scarred uterus
  • No medical diseases as hypertension
  • No obstetric complications as obstructed labor
  • Women accepted to participate in the study

You may not qualify if:

  • Multiple pregnancy
  • Women with Previous cesarean sections
  • Preterm labor
  • Malpresentation
  • Fetal macrosomia
  • Medical diseases as diabetes and hypertension
  • Women refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Episiotomy

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

April 2, 2018

Study Completion

June 2, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Locations

EG(1)