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
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
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
NCT ID
NCT00525486
First Posted
September 2, 2007
Last Updated
December 22, 2010
Sponsor
The Baruch Padeh Medical Center, Poriya
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
Learn more about this trial
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery
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