The NIFTY study: A Multi-centre Randomised Double Blind Placebo Controlled Trial of Nifedipine Maintenance Tocolysis in Fetal Fibronectin Positive Women in Threatened Preterm Labour

Effect of Maintenance Tocolysis with Nifedipine on Prolongation of Pregnancy in Women with Threatened Preterm Labour and Positive Fetal Fibronectin Status

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000985785

Acronym

NIFTY

Enrollment

100

Registered

2013-09-04

Start date

2003-10-18

Completion date

2007-07-25

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

We aimed to determine whether maintenance nifedipine treatment in women in spontaneous preterm labour and with positive fetal fibronectin would prolong pregnancy and reduce neonatal unit admission.

Interventions

Arm 1: Nifedipine orally slow release 20 mg eight hourly, on occasion this may be increased up to a maximum of 160 mg in 24 hours (in case of ongoing contractions) until 36 completed gestational weeks Arm 2: Identical placebo

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women with threatened preterm labour, a singleton pregnancy, gestational age between 24 and 34 weeks, intact membranes, positive fetal fibronectin test, completed course of corticosteroids

Exclusion criteria

Ruptured membranes, suspicion of chorioamnionitis, antepartum haemorrhage or suspected concealed abruption, major fetal anomaly, contraindication to nifedipine treatment

Outcome results