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Completed

NCT Number: NCT00185952

Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Completed

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Key information

Conditions

Obstetric Labor, Premature Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Thrombosis Urogenital Diseases Vascular Diseases Venous Thrombosis

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • arrested preterm labor

Exclusion criteria

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

Treatment and study plan

nifedipine

Drug

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

Primary outcomes

  1. Achieving 37 weeks gestation

    Time frame: delivery

Secondary outcomes

  1. Incidence of recurrent preterm labor

    Time frame: Delivery

  2. Neonatal outcomes

    Time frame: Discharge of neonate

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Santa Clara Valley Health & Hospital System

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Jun 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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