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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT02486822 |
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Date of registration:
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24/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Labor Scale Versus WHO Partograph in the Management of Labor
SLiP |
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Scientific title:
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The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02486822 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Sherif AM Shazly, MBBCh,MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistant lecturer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primigravida
- 38 - 42 weeks of gestation
- Singleton pregnancy
- Vertex presentation
- Spontaneous labour
- Average estimated fetal weight (2500 - 3800 gram)
Exclusion Criteria:
- Maternal medical or surgical major co-morbidity
- Previous uterine scar
- Induction of labor
- Premature rupture of membranes
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Dystocia
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Intervention(s)
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Procedure: Amniotomy
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Drug: Oxytocin
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Procedure: Cesarean Section
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Primary Outcome(s)
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Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
[Time Frame: Time of labor (maximum 24 hours)]
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Secondary Outcome(s)
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Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)
[Time Frame: Time of labor (maximum 24 hours)]
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Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture
[Time Frame: The length of hospital stay (expected average 72 hours)]
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birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )
[Time Frame: The length of hospital stay (expected average 1 week)]
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Neonatal distress "asphyxia" (as reported 1 & 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to NICU, length of stay and any further medical complications)
[Time Frame: The length of hospital/NICU stay (expected average 1 week)]
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Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions
[Time Frame: The length of hospital stay (expected average 72 hours)]
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Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring
[Time Frame: Duration of labor (maximum 24 hours)]
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Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)
[Time Frame: Time of labour and hospital stay (expected average 72 hours)]
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Secondary ID(s)
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IRB00008718 - SLiP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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