Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185952

Enrollment

Registered

2005-09-16

Start date

2001-11-30

Completion date

2008-08-31

Last updated

2011-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor, Premature, Venous Thrombosis

Brief summary

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Detailed description

To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.

Interventions

DRUGNifedipine

Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

\- arrested preterm labor

Exclusion criteria

\- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis

Design outcomes

Primary

Measure	Time frame
Achieving 37 weeks gestation	delivery

Secondary

Measure	Time frame
Incidence of recurrent preterm labor	Delivery
Neonatal outcomes	Discharge of neonate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026