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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

Tracking Information
First Submitted Date  ICMJE March 13, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date August 20, 2019
Study Start Date  ICMJE March 2016
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Rate of third and forth degree perineal tears [ Time Frame: intraoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2019)
Rate of first and second degree perineal tears [ Time Frame: intraoperative ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Prediction of Perineal Tears by Striae Gravidarum Score
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Normal Labor
Intervention  ICMJE Procedure: Episiotomy
episiotomy will be done after crowning of the fetal head
Study Arms  ICMJE
  • Experimental: Group A
    Episiotomy
    Intervention: Procedure: Episiotomy
  • No Intervention: Group B
    no episiotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2, 2018
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717676
Other Study ID Numbers  ICMJE TSS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP