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NCT00525486 Clinical Trial

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Preterm Labor Clinical Trial

Official title:
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00525486
Other study ID # PTL prevention Nifedipine
Secondary ID
Status Terminated
Phase N/A
First received September 2, 2007
Last updated December 22, 2010
Start date December 2007

Study information
Verified date December 2010
Source The Baruch Padeh Medical Center, Poriya
Contact n/a
Is FDA regulated No
Health authority Israel:IRB Commission (local)
Study type Interventional

Clinical Trial Summary

To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group.

The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- pregnancy week 24-33

- Singleton pregnancy

- After successful treatment to stop PTL

Exclusion Criteria:

- Contraindications for Nifedipine extended release treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine extended release
Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya
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