Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

ClinicalTrials.gov Identifier:

NCT01360034

First received: May 20, 2011

Last updated: January 1, 2015

Last verified: January 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2011

Last Updated Date

January 1, 2015

Start Date ^ICMJE

December 2015

Estimated Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01360034 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction of preterm labour (before 35 weeks). [ Time Frame: 48 months ]
Adverse effects [ Time Frame: 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Obstetric Labor, Premature

Intervention ^ICMJE

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

Study Arms

Experimental: Nifedipine
108 patients will receive nifedipine as tocolytic for 48 hours.

Intervention: Drug: Nifedipine
Experimental: Indomethacin
108 patients will receive indomethacin as tocolytic for 48 hours.

Intervention: Drug: Indomethacin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

216

Estimated Completion Date

June 2016

Estimated Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender

Sexes Eligible for Study:

Female

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Panama

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01360034

Other Study ID Numbers ^ICMJE

MHST2011-04

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Study Sponsor ^ICMJE

Saint Thomas Hospital, Panama

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Jorge Espinosa, Resident	Saint Thomas Hospital, Panama
Principal Investigator:	Osvaldo Reyes, MD	Saint Thomas Hospital, Panama

PRS Account

Saint Thomas Hospital, Panama

Verification Date

January 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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