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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: |
NCT00141908 |
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Date of registration:
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01/09/2005 |
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Primary sponsor: |
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Public title:
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Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate
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Scientific title:
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Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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290 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00141908 |
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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: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Adnan Mroueh, MD |
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Address:
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Telephone:
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+961-1-350000 |
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Email:
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am36@aub.edu.lb |
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Affiliation:
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Name:
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Anwar H Nassar, MD |
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Address:
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Telephone:
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+961-1-340460 |
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Email:
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an21@aub.edu.lb |
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Affiliation:
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Name:
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Anwar H Nassar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Viable twin pregnancy
- Current pregnancy between 16 weeks and 20 weeks of gestation
Exclusion Criteria:
- Known fetal anomaly in either twin
- Current or planned cervical cerclage
- Hypertension requiring medication
- Diabetes Mellitus
- Asthma
- History of deep vein thrombosis
- Preexisting cardiac or renal disease
- A seizure disorder
- Plans to deliver elsewhere
- Previous or existing liver tumors
- History of herpes gestationis of pregnancy
Age minimum:
16 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Premature Birth
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Intervention(s)
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Drug: 17-alpha Hydroxyprogesterone Caproate
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Drug: Castor oil
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Primary Outcome(s)
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The frequency of delivery prior to completed 37 weeks of gestation (259 days).
[Time Frame: one year]
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Secondary Outcome(s)
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Birth weight < 1500 grams, Fetal death, antepartum or intrapartum, Neonatal intensive care unit admissions, Respiratory distress syndrome,
[Time Frame: 9 months]
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Delivery before 35 weeks of gestation, Delivery before 32 weeks of gestation, Admission during current pregnancy for preterm labor,
[Time Frame: 9 months]
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Need for tocolytic therapy in current pregnancy, Need for corticosteroids to enhance fetal lung maturity, Route of delivery,
[Time Frame: 9 months]
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Obstetrical complications (antepartum and intrapartum) of pregnancy, Indicated preterm deliveries, Neonatal outcome variables ( Birth weight < 2500 grams,
[Time Frame: 9 months]
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Secondary ID(s)
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OGY.AN.04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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