Prediction of Perineal Tears by Striae Gravidarum Score

Normal Labor Clinical Trial

— TSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717676
• Other study ID #: TSS
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 2, 2018

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Labor

Intervention

Procedure:
• Episiotomy
episiotomy will be done after crowning of the fetal head

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of third and forth degree perineal tears		intraoperative
Secondary	Rate of first and second degree perineal tears		intraoperative