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The NIFTY study: a multicentre randomised double-blind placebo-controlled trial of nifedipine maintenance tocolysis in fetal fibronectin-positive women in threatened preterm labour.
Aust N Z J Obstet Gynaecol. 2014 Jun; 54(3):231-6.AN

Abstract

OBJECTIVE

In an unselected group of women with signs of preterm labour, maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome. Among women with signs of preterm labour, those who are fetal fibronectin positive have an increased risk of preterm birth. We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status.

STUDY DESIGN

Women with a singleton pregnancy in threatened preterm labour (24(+0) to 33(+6) weeks) with a positive fetal fibronectin test were randomised to nifedipine or placebo. Study medication was continued until 36 completed weeks' gestation. The primary endpoint was prolongation of pregnancy of seven days. Secondary endpoints were gestational age at delivery and length of NICU admission.

RESULTS

Of the 60 participants, 29 received nifedipine and 31 placebo. Prolongation of pregnancy by >7 days occurred in 22/29 (76%) in the nifedipine group and 25/31 (81%) in the placebo group (relative risks, RR 0.94 [0.72-1.2]). Gestational age at delivery was 36.1 ± 5.1 weeks for nifedipine and 36.8 ± 3.6 weeks for placebo (P = 0.027). Length of NICU admission [median (interquartile ranges, IQR)] was 27 (24-41) days and 16 (8-37) days in nifedipine and placebo groups, respectively (P = 0.17).

CONCLUSION

In women with threatened preterm labour who are fetal fibronectin positive, maintenance tocolysis with nifedipine does not seem to prolong pregnancy, nor reduce length of NICU admission.

Authors+Show Affiliations

Maternal-Fetal Medicine, Auckland District Health Board, Auckland, New Zealand.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24506318

Citation

Parry, Emma, et al. "The NIFTY Study: a Multicentre Randomised Double-blind Placebo-controlled Trial of Nifedipine Maintenance Tocolysis in Fetal Fibronectin-positive Women in Threatened Preterm Labour." The Australian & New Zealand Journal of Obstetrics & Gynaecology, vol. 54, no. 3, 2014, pp. 231-6.
Parry E, Roos C, Stone P, et al. The NIFTY study: a multicentre randomised double-blind placebo-controlled trial of nifedipine maintenance tocolysis in fetal fibronectin-positive women in threatened preterm labour. Aust N Z J Obstet Gynaecol. 2014;54(3):231-6.
Parry, E., Roos, C., Stone, P., Hayward, L., Mol, B. W., & McCowan, L. (2014). The NIFTY study: a multicentre randomised double-blind placebo-controlled trial of nifedipine maintenance tocolysis in fetal fibronectin-positive women in threatened preterm labour. The Australian & New Zealand Journal of Obstetrics & Gynaecology, 54(3), 231-6. https://doi.org/10.1111/ajo.12179
Parry E, et al. The NIFTY Study: a Multicentre Randomised Double-blind Placebo-controlled Trial of Nifedipine Maintenance Tocolysis in Fetal Fibronectin-positive Women in Threatened Preterm Labour. Aust N Z J Obstet Gynaecol. 2014;54(3):231-6. PubMed PMID: 24506318.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The NIFTY study: a multicentre randomised double-blind placebo-controlled trial of nifedipine maintenance tocolysis in fetal fibronectin-positive women in threatened preterm labour. AU - Parry,Emma, AU - Roos,Carolien, AU - Stone,Peter, AU - Hayward,Lynsey, AU - Mol,Ben Willem, AU - McCowan,Lesley, Y1 - 2014/02/08/ PY - 2013/09/14/received PY - 2013/12/16/accepted PY - 2014/2/11/entrez PY - 2014/2/11/pubmed PY - 2014/10/29/medline KW - maintenance tocolysis KW - nifedipine KW - preterm labour SP - 231 EP - 6 JF - The Australian & New Zealand journal of obstetrics & gynaecology JO - Aust N Z J Obstet Gynaecol VL - 54 IS - 3 N2 - OBJECTIVE: In an unselected group of women with signs of preterm labour, maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome. Among women with signs of preterm labour, those who are fetal fibronectin positive have an increased risk of preterm birth. We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status. STUDY DESIGN: Women with a singleton pregnancy in threatened preterm labour (24(+0) to 33(+6) weeks) with a positive fetal fibronectin test were randomised to nifedipine or placebo. Study medication was continued until 36 completed weeks' gestation. The primary endpoint was prolongation of pregnancy of seven days. Secondary endpoints were gestational age at delivery and length of NICU admission. RESULTS: Of the 60 participants, 29 received nifedipine and 31 placebo. Prolongation of pregnancy by >7 days occurred in 22/29 (76%) in the nifedipine group and 25/31 (81%) in the placebo group (relative risks, RR 0.94 [0.72-1.2]). Gestational age at delivery was 36.1 ± 5.1 weeks for nifedipine and 36.8 ± 3.6 weeks for placebo (P = 0.027). Length of NICU admission [median (interquartile ranges, IQR)] was 27 (24-41) days and 16 (8-37) days in nifedipine and placebo groups, respectively (P = 0.17). CONCLUSION: In women with threatened preterm labour who are fetal fibronectin positive, maintenance tocolysis with nifedipine does not seem to prolong pregnancy, nor reduce length of NICU admission. SN - 1479-828X UR - https://www.unboundmedicine.com/medline/citation/24506318/The_NIFTY_study:_a_multicentre_randomised_double_blind_placebo_controlled_trial_of_nifedipine_maintenance_tocolysis_in_fetal_fibronectin_positive_women_in_threatened_preterm_labour_ L2 - https://doi.org/10.1111/ajo.12179 DB - PRIME DP - Unbound Medicine ER -