Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00185952
• Collaborator: Santa Clara Valley Health & Hospital System (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 81
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Condition or Disease	Intervention/Treatment	Phase
Obstetric Labor, Premature; Venous Thrombosis	Drug: Nifedipine	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nifedipine Maintenance tocolysis with nifedipine.	Drug: Nifedipine; Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
Placebo Comparator: Placebo Maintenance tocolysis with placebo tablets.	Drug: Nifedipine; Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.

Outcome Measures

Primary Outcome Measures

1. Achieving 37 weeks gestation [delivery]

Secondary Outcome Measures

1. Incidence of recurrent preterm labor [Delivery]

2. Neonatal outcomes [Discharge of neonate]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• arrested preterm labor

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• Santa Clara Valley Health & Hospital System

Investigators

• Principal Investigator: Yasser Yehia El-Sayed, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00185952
• Other Study ID Numbers: 76251
• First Posted: Sep 16, 2005
• Last Update Posted: Jun 13, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Obstetric Labor, Premature; Thrombosis; Venous Thrombosis; Nifedipine

Study Results

No Results Posted as of Jun 13, 2011