Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

NCT00486824

Obstetric Labor, Premature

COMPLETED PHASE1/PHASE2

Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

NCT03129945

Obstetric Labor, Premature

COMPLETED NA

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

NCT02438371

Preterm Labor

TERMINATED PHASE4

Nifedipine for Acute Tocolysis of Preterm Labor

NCT02132533

Preterm Labor

COMPLETED PHASE3

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

NCT00525486

Preterm Labor

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Labor, Premature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nifedipine

108 patients will receive nifedipine as tocolytic for 48 hours.

Group Type EXPERIMENTAL

Nifedipine

Intervention Type DRUG

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

Indomethacin

108 patients will receive indomethacin as tocolytic for 48 hours.

Group Type EXPERIMENTAL

Indomethacin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nifedipine

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

Intervention Type DRUG

Indomethacin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No