Prediction of Perineal Tears by Striae Gravidarum Score

NCT ID: NCT02717676

Last Updated: 2019-08-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Normal Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Episiotomy

Group Type EXPERIMENTAL

Episiotomy

Intervention Type PROCEDURE

episiotomy will be done after crowning of the fetal head

Group B

no episiotomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Episiotomy

episiotomy will be done after crowning of the fetal head

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TSS

Identifier Type: -

Identifier Source: org_study_id

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