Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

NCT ID: NCT00525486

Last Updated: 2010-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Labor

Keywords

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Nifedipine Tocolysis Maintenance Preterm delivery extended release nifedipine PTL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

Nifedipine extended release

Intervention Type DRUG

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

B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nifedipine extended release

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

Intervention Type DRUG

Other Intervention Names

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Osmo-Adalat 30 mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications for Nifedipine extended release treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Yuri Perlitz, MD

Role: PRINCIPAL_INVESTIGATOR

The Baruch Padeh Medical Center, Poria, Israel.

References

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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.

Reference Type DERIVED
PMID: 35947046 (View on PubMed)

Other Identifiers

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PTL prevention Nifedipine

Identifier Type: -

Identifier Source: org_study_id