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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Primary Purpose

Obstetric Labor, Premature

Status
Unknown status
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Nifedipine
Indomethacin
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor, Premature focused on measuring Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Saint Thomas Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nifedipine

Indomethacin

Arm Description

108 patients will receive nifedipine as tocolytic for 48 hours.

108 patients will receive indomethacin as tocolytic for 48 hours.

Outcomes

Primary Outcome Measures

Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).

Secondary Outcome Measures

Reduction of preterm labour (before 35 weeks).
Adverse effects
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.

Full Information

First Posted
May 20, 2011
Last Updated
January 1, 2015
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT01360034
Brief Title
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Official Title
Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor, Premature
Keywords
Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Experimental
Arm Description
108 patients will receive nifedipine as tocolytic for 48 hours.
Arm Title
Indomethacin
Arm Type
Experimental
Arm Description
108 patients will receive indomethacin as tocolytic for 48 hours.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
Primary Outcome Measure Information:
Title
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Reduction of preterm labour (before 35 weeks).
Time Frame
48 months
Title
Adverse effects
Description
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.
Time Frame
48 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Espinosa, Resident
Email
bobbyone-79@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Osvaldo Reyes, MD
Email
oreyespanama@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Espinosa, Resident
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas Hospital
City
Panama
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived

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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

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