Clinical Trials Logo
  1. Home
  2. Preterm Labor
  3. NCT00525486
  4. Details
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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06168149 - The Relationship of Fetal Lung Elastography Values With the Development of Respiratory Distress in Cases of Preterm Labor
Completed NCT02538718 - Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor N/A
Not yet recruiting NCT05864066 - Cyclin-dependent Kinase Inhibitor 2A (Placental Senescence Marker) on Labor-related Signals
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Withdrawn NCT03122704 - Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF N/A
Completed NCT02536352 - Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being Early Phase 1
Recruiting NCT01518816 - Role of Serum Total Antioxidant Level in Preterm Labor N/A
Recruiting NCT04590677 - Prediction of the Onset of Term and Preterm Labour
Completed NCT03112018 - Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda N/A
Active, not recruiting NCT04301518 - Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs N/A
Completed NCT03785795 - Multichannel EMG Diagnosing True Preterm Labor
Withdrawn NCT02351310 - Effectiveness of ACS in Extreme Preemies Phase 3
Not yet recruiting NCT01985594 - Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial Phase 2
Not yet recruiting NCT04532086 - Uterocervical Angle and Preterm Labour
Completed NCT04605172 - Lockdown Impact on Spontaneous Premature Birth in a Level III NICU
Recruiting NCT04417595 - Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS Phase 2
Completed NCT03923023 - Impact of the PREEMI Package on Neonatal Mortality
Recruiting NCT06157203 - Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients