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Prediction of Perineal Tears by Striae Gravidarum Score (TSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717676
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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.

Condition or disease Intervention/treatment Phase
Normal Labor Procedure: Episiotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score
Study Start Date : March 2016
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : June 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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



Primary Outcome Measures :
  1. Rate of third and forth degree perineal tears [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Rate of first and second degree perineal tears [ Time Frame: intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717676


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02717676    
Other Study ID Numbers: TSS
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes