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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01429545 |
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Date of registration:
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01/09/2011 |
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Primary sponsor: |
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Public title:
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Single Versus Combination Therapy in Acute Tocolysis
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Scientific title:
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Phase 2 Study of Clinical Utility of Combination Tocolysis in Preterm Labor |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01429545 |
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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: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Arab Emirates
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Contacts
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Name:
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Wafa R AlOmari |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tawam Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of preterm labour
- Women with singleton pregnancies
Exclusion Criteria:
- Women with preterm prelabour rupture of membranes
- Women with any indication for emergency delivery for whom prolongation of pregnancy
is contraindicated
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preterm Labour
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Intervention(s)
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Drug: Atosiban
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Drug: Atosiban and nifedipine
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Primary Outcome(s)
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Number of Babies with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 weeks]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[Time Frame: Participants will be followed for the duration of pregnancy, an expected average of 10 weeks]
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Number of women undelivered 48 hrs and seven days of initiation of therapy
[Time Frame: Participants who are not delivered within seven days of initiation of therapy]
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Secondary Outcome(s)
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Neonatal intensive care unit (NICU) admission
[Time Frame: Till the time of discharge, an expected avearge of 7 weeks]
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Prolongation of pregnancy
[Time Frame: Assessed till the date of delivery, an expected average of 10 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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