Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Obstetric Labor, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01360034
• Other study ID #: MHST2011-04
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 20, 2011
• Last updated: January 1, 2015
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: Jorge Espinosa, Resident
• Email: bobbyone-79[@]hotmail.com
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor, Premature

Intervention

Drug:
• Nifedipine
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
• Indomethacin
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.

Locations

Country	Name	City	State
Panama	Saint Thomas Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).		36 months	No
Secondary	Reduction of preterm labour (before 35 weeks).		48 months	No
Secondary	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.	48 months	Yes