Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Information source: Saint Thomas Hospital, Panama
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstetric Labor, Premature
Intervention: Nifedipine (Drug); Indomethacin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Saint Thomas Hospital, Panama Official(s) and/or principal investigator(s): Jorge Espinosa, Resident, Principal Investigator, Affiliation: Saint Thomas Hospital, Panama Osvaldo Reyes, MD, Principal Investigator, Affiliation: Saint Thomas Hospital, Panama
Overall contact: Jorge Espinosa, Resident, Email: bobbyone-79@hotmail.com
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).
Clinical Details
Official title: Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
Secondary outcome: Reduction of preterm labour (before 35 weeks).Adverse effects
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Jorge Espinosa, Resident, Email: bobbyone-79@hotmail.com
Saint Thomas Hospital, Panama, Panama
Additional Information
Starting date: December 2015
Last updated: January 1, 2015
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