Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000985785
Ethics application status
Approved
Date submitted
31/08/2013
Date registered
4/09/2013
Date last updated
4/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
Effect of Maintenance Tocolysis with Nifedipine on Prolongation of Pregnancy in Women with Threatened Preterm Labour and Positive Fetal Fibronectin Status
Secondary ID [1] 283095 0
Nil
Universal Trial Number (UTN)
Trial acronym
NIFTY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Labour 289932 0
Condition category
Condition code
Reproductive Health and Childbirth 290307 290307 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 287813 0
Treatment: Drugs
Comparator / control treatment
Placebo, ironoxide
Control group
Placebo

Outcomes
Primary outcome [1] 290344 0
Duration of pregnancy, time between randomisation and delivery.
Timepoint [1] 290344 0
End of pregnancy, defined as date of delivery
Secondary outcome [1] 304332 0
Reduction of neonatal admission by greater than 4 days
Timepoint [1] 304332 0
At discharge from neonatal admission unit, duration of neonatal admission defined by discharge date minus admission date

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Ruptured membranes, suspicion of chorioamnionitis, antepartum haemorrhage or suspected concealed abruption, major fetal anomaly, contraindication to nifedipine treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using computer generated numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a previous study at National Women's Hospital, it was shown that women in preterm labour who were Fetal Fibronectin positive had a median time from presentation to delivery of 35 days, whereas those who were fibronectin negative had a median time to delivery of 51 days. If nifedipine treatment increased the duration of pregnancy by at least seven days in those who were positive, that would be a substantial benefit to the infant. The sample size required to extend the duration of pregnancy by seven days (SD14) was 50 in each group, with a power of 80% at a significance level of 0.05 (two-sided).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2003
Actual
18/10/2003
Date of last participant enrolment
Anticipated
Actual
25/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5343 0
New Zealand
State/province [1] 5343 0

Funding & Sponsors
Funding source category [1] 287849 0
Charities/Societies/Foundations
Name [1] 287849 0
Auckland Medical Research Foundation
Country [1] 287849 0
New Zealand
Funding source category [2] 287859 0
Charities/Societies/Foundations
Name [2] 287859 0
Douglas Pharmacy
Country [2] 287859 0
New Zealand
Primary sponsor type
Hospital
Name
Emma Parry
Address
Auckland District Health Board, Maternal-Fetal Medicine
Private Bag 92 024, Auckland Mail Centre. Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286579 0
University
Name [1] 286579 0
Lesley McCowan
Address [1] 286579 0
University of Auckland, Department of Obstetrics and Gynaecology
Private Bag 92 019, Auckland Mail Centre. Auckland 1142
Country [1] 286579 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289791 0
Auckland regional Ethics committee
Ethics committee address [1] 289791 0
Ethics committee country [1] 289791 0
New Zealand
Date submitted for ethics approval [1] 289791 0
Approval date [1] 289791 0
05/02/2003
Ethics approval number [1] 289791 0
AKY/02/00/148

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42454 0
Dr Emma Parry
Address 42454 0
Auckland District Health Board, Maternal-Fetal Medicine, Private Bag 92 024, Auckland Mail Centre. Auckland. 1142.
Country 42454 0
New Zealand
Phone 42454 0
+6493074992
Fax 42454 0
Email 42454 0
EmmaP@adhb.govt.nz
Contact person for public queries
Name 42455 0
Carolien Roos
Address 42455 0
Hospital Gelderse Vallei
Willy Brandtlaan 10
6716 RP Ede
Country 42455 0
Netherlands
Phone 42455 0
+31611195142
Fax 42455 0
Email 42455 0
carolienroos@hotmail.com
Contact person for scientific queries
Name 42456 0
Carolien Roos
Address 42456 0
Hospital Gelderse Vallei
Willy Brandtlaan 10
6716 RP Ede
Country 42456 0
Netherlands
Phone 42456 0
+31611195142
Fax 42456 0
Email 42456 0
carolienroos@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.