Prediction of Perineal Tears by Striae Gravidarum Score (TSS)

• ClinicalTrials.gov Identifier: NCT02717676
• Recruitment Status: Completed
• First Posted: March 24, 2016
• Last Update Posted: August 20, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ahmed Mohamed Abbas, Assiut University

Tracking Information

• First Submitted Date: March 13, 2016
• First Posted Date: March 24, 2016
• Last Update Posted Date: August 20, 2019
• Study Start Date: March 2016
• Actual Primary Completion Date: April 2, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 18, 2016): Rate of third and forth degree perineal tears [ Time Frame: intraoperative ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 17, 2019): Rate of first and second degree perineal tears [ Time Frame: intraoperative ]

Original Secondary Outcome Measures (submitted: March 18, 2016)

• Rate of first and second degree perineal tears [ Time Frame: intraoperative ]
• Rate of superficial perineal lacerations [ Time Frame: intraoperative ]
• Need for blood transfusion [ Time Frame: 2 hours ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prediction of Perineal Tears by Striae Gravidarum Score
• Official Title: Episiotomy for Prevention of Perineal Tears During Labor in Women With High Striae Gravidarum Score
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Normal Labor

Intervention

Procedure: Episiotomy

episiotomy will be done after crowning of the fetal head

Study Arms

• Experimental: Group A
  Episiotomy
  Intervention: Procedure: Episiotomy
• No Intervention: Group B
  no episiotomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 18, 2016): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2, 2018
• Actual Primary Completion Date: April 2, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT02717676
• Other Study ID Numbers: TSS
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Ahmed Mohamed Abbas, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: August 2019