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Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Primary Purpose

Preterm Labor

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nifedipine extended release
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Labor focused on measuring Nifedipine, Tocolysis, Maintenance, Preterm delivery, extended release nifedipine, PTL

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnancy week 24-33
  • Singleton pregnancy
  • After successful treatment to stop PTL

Exclusion Criteria:

  • Contraindications for Nifedipine extended release treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A

    B

    Arm Description

    The treated group of pregnant women, after having successful treatment for PTL

    The no treatment arm of women treated with tocolysis for PTL.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 2, 2007
    Last Updated
    December 22, 2010
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00525486
    Brief Title
    Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
    Official Title
    Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Labor
    Keywords
    Nifedipine, Tocolysis, Maintenance, Preterm delivery, extended release nifedipine, PTL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    The treated group of pregnant women, after having successful treatment for PTL
    Arm Title
    B
    Arm Type
    No Intervention
    Arm Description
    The no treatment arm of women treated with tocolysis for PTL.
    Intervention Type
    Drug
    Intervention Name(s)
    Nifedipine extended release
    Other Intervention Name(s)
    Osmo-Adalat 30 mg
    Intervention Description
    Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: pregnancy week 24-33 Singleton pregnancy After successful treatment to stop PTL Exclusion Criteria: Contraindications for Nifedipine extended release treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuri Perlitz, MD
    Organizational Affiliation
    The Baruch Padeh Medical Center, Poria, Israel.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35947046
    Citation
    Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
    Results Reference
    derived

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    Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

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