Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Saint Thomas Hospital (HST)

Status and phase: Unknown; Phase 3

Conditions: Obstetric Labor, Premature

Treatments: Drug: Indomethacin; Drug: Nifedipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01360034

MHST2011-04

Details and patient eligibility

About

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).

Enrollment: 216 estimated patients

Sex: Female

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Nifedipine

Experimental group

Description:

108 patients will receive nifedipine as tocolytic for 48 hours.

Treatment:

Drug: Nifedipine

Indomethacin

Experimental group

Description:

108 patients will receive indomethacin as tocolytic for 48 hours.

Treatment:

Drug: Indomethacin