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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

Page last updated: August 23, 2015

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