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Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Information source: The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: Nifedipine extended release (Drug)

Phase: N/A

Status: Terminated

Sponsored by: The Baruch Padeh Medical Center, Poriya

Official(s) and/or principal investigator(s):
Yuri Perlitz, MD, Principal Investigator, Affiliation: The Baruch Padeh Medical Center, Poria, Israel.


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.

Clinical Details

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

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


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


Inclusion Criteria:

- pregnancy week 24-33

- Singleton pregnancy

- After successful treatment to stop PTL

Exclusion Criteria:

- Contraindications for Nifedipine extended release treatment.

Locations and Contacts

Additional Information

Starting date: December 2007
Last updated: December 22, 2010

Page last updated: August 23, 2015

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