Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Sponsor

Saint Thomas Hospital, Panama (Other)

Overall Status

Unknown status

CT.gov ID

NCT01360034

Collaborator

(none)

216

Enrollment

Location

Arms

Duration (Months)

35.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obstetric Labor, Premature	Drug: Nifedipine Drug: Indomethacin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nifedipine 108 patients will receive nifedipine as tocolytic for 48 hours.	Drug: Nifedipine Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
Experimental: Indomethacin 108 patients will receive indomethacin as tocolytic for 48 hours.	Drug: Indomethacin Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.

Arm

Intervention/Treatment

Experimental: Nifedipine

108 patients will receive nifedipine as tocolytic for 48 hours.

Drug: Nifedipine

Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.

Experimental: Indomethacin

108 patients will receive indomethacin as tocolytic for 48 hours.

Drug: Indomethacin

Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.

Outcome Measures

Primary Outcome Measures

Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [36 months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).