Obstetric Labor, Premature
Conditions
Keywords
Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin
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).
Interventions
DRUGNifedipine
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
DRUGIndomethacin
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
Sponsors
Saint Thomas Hospital, Panama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of preterm labour (before 35 weeks). | 48 months | — |
| 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. |
Countries
Panama
Contacts
Primary ContactJorge Espinosa, Resident
Backup ContactOsvaldo Reyes, MD
Outcome results
None listed