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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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12 December 2020 |
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Main ID: |
NCT03518684 |
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Date of registration:
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16/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma
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Scientific title:
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Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial |
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Date of first enrolment:
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April 3, 2018 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03518684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 18 and 40 years
- Intended vaginal delivery
- Singleton baby in vertex presentation
- Low risk pregnancy at term (37-42 weeks of gestation)
- Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
- Signed written informed consent
Exclusion Criteria:
- Contraindications for vaginal delivery (placenta previa, active herpes infection,
etc…)
- Advanced cervical dilation (= 5 cm)
- Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia,
abdominal pain)
- Non reassuring fetal heart tracing
- Prolonged rupture of the membranes (24 hours)
- Suspected major fetal malformations
- Suspected cephalopelvic disproportion
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Labor Stage, Second
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Intervention(s)
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Drug: Natalis
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Primary Outcome(s)
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Reduction in the length of the second stage of labor
[Time Frame: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes]
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Secondary ID(s)
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OGY.EH.03
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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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