Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
- Registration Number
- NCT01360034
- Lead Sponsor
- Saint Thomas Hospital, Panama
- Brief Summary
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (\< 2.5cms).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 216
Inclusion Criteria
- Pregnant women between 24 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less
Exclusion Criteria
- All contraindications for tocolysis (fetal distress, abruptio placenta).
- Multiple pregnancy.
- All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nifedipine Nifedipine 108 patients will receive nifedipine as tocolytic for 48 hours. Indomethacin Indomethacin 108 patients will receive indomethacin as tocolytic for 48 hours.
- Primary Outcome Measures
Name Time Method Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). 36 months
- Secondary Outcome Measures
Name Time Method Adverse effects 48 months To determine the frequency of maternal adverse effects related to the use of both drugs (nifedipine and indomethacin). These include the development of any type of rash, nausea, weakness/hypotension, headache, dyspepsy or bleeding disorders of any kind.
Reduction of preterm labour (before 35 weeks). 48 months
Trial Locations
- Locations (1)
Saint Thomas Hospital
🇵🇦Panama, Panama