Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00525486

Enrollment

Unknown

Registered

2007-09-05

Start date

2007-12-31

Completion date

Unknown

Last updated

2010-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

Keywords

Nifedipine, Tocolysis, Maintenance, Preterm delivery, extended release nifedipine, PTL

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.

Interventions

DRUGNifedipine extended release

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Contraindications for Nifedipine extended release treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026