Prediction of Perineal Tears by Striae Gravidarum Score (TSS)

Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score

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.

Study Overview

• Status: Completed
• Conditions: Normal Labor
• Intervention / Treatment: Procedure: Episiotomy

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

1. Multipara
2. Singleton pregnancy
3. Full-term (37- 40 weeks)
4. Average size fetus (2500-4000 gm)
5. Cephalic-vertex presentation
6. Spontaneous onset of labor
7. No scarred uterus
8. No medical diseases as hypertension
9. No obstetric complications as obstructed labor
10. Women accepted to participate in the study

Exclusion criteria:

1. Multiple pregnancy
2. Women with Previous cesarean sections
3. Preterm labor
4. Malpresentation
5. Fetal macrosomia
6. Medical diseases as diabetes and hypertension
7. Women refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Episiotomy	Procedure: Episiotomy; episiotomy will be done after crowning of the fetal head
No Intervention: Group B; no episiotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of third and forth degree perineal tears	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of first and second degree perineal tears	intraoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 2, 2018
• Study Completion (Actual): June 2, 2018

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 17, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES