Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Baruch Padeh Medical Center

Status: Terminated

Conditions: Preterm Labor

Treatments: Drug: Nifedipine extended release

Study type: Interventional

Funder types: Other

Identifiers

NCT00525486

PTL prevention Nifedipine

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Contraindications for Nifedipine extended release treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Nifedipine extended release

B

No Intervention group

Description:

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