Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
1 other identifier
interventional
216
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 5, 2015
January 1, 2015
5 months
May 20, 2011
January 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
36 months
Secondary Outcomes (2)
Reduction of preterm labour (before 35 weeks).
48 months
Adverse effects
48 months
Study Arms (2)
Nifedipine
EXPERIMENTAL108 patients will receive nifedipine as tocolytic for 48 hours.
Indomethacin
EXPERIMENTAL108 patients will receive indomethacin as tocolytic for 48 hours.
Interventions
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
Eligibility Criteria
You may qualify if:
- Pregnant women between 24 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less
You may not qualify if:
- All contraindications for tocolysis (fetal distress, abruptio placenta).
- Multiple pregnancy.
- All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Thomas Hospital
Panama City, Provincia de Panamá, Panama
Related Publications (1)
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PMID: 35947046DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Espinosa, Resident
Saint Thomas Hospital, Panama
- PRINCIPAL INVESTIGATOR
Osvaldo Reyes, MD
Saint Thomas Hospital, Panama
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 25, 2011
Study Start
December 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
January 5, 2015
Record last verified: 2015-01