Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis

E. O G van Vliet, G. H. Dijkema, E. Schuit, K. Y. Heida, C. Roos, J. A M van der Post, E. C. Parry, L. McCowan, D. J. Lyell, Y. Y. El-Sayed, D. B. Carr, A. L. Clark, Zaleha Abdullah Mahdy, M. Uma, N. C. Sayin, G. F. Varol, B. W. Mol, M. A. Oudijk

Research output: Contribution to journalReview article

13 Citations (Scopus)

Abstract

Background: Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven. Objectives: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA). Search strategy: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour. Selection criteria: We selected trials including pregnant women between 24 and 366/7 weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment. Data collection and analysis: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed. Main results: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35–5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16–2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50–2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51–1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55–1.01). Conclusion: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice. Tweetable abstract: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.

Original languageEnglish
Pages (from-to)1753-1760
Number of pages8
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume123
Issue number11
DOIs
Publication statusPublished - 1 Oct 2016

Fingerprint

Tocolysis
Nifedipine
Meta-Analysis
Maintenance
Newborn Respiratory Distress Syndrome
Necrotizing Enterocolitis
Premature Obstetric Labor
Pregnancy Outcome
Pregnancy
Gestational Age
Randomized Controlled Trials
Placebos
Hemorrhage
Perinatal Mortality
Neonatal Intensive Care Units
Premature Birth
Infant Mortality
Developed Countries
PubMed
Patient Selection

Keywords

  • Individual participant data meta-analysis
  • maintenance tocolysis
  • nifedipine
  • outcome
  • preterm birth

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

van Vliet, E. O. G., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A. M., ... Oudijk, M. A. (2016). Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis. BJOG: An International Journal of Obstetrics and Gynaecology, 123(11), 1753-1760. https://doi.org/10.1111/1471-0528.14249

Nifedipine maintenance tocolysis and perinatal outcome : an individual participant data meta-analysis. / van Vliet, E. O G; Dijkema, G. H.; Schuit, E.; Heida, K. Y.; Roos, C.; van der Post, J. A M; Parry, E. C.; McCowan, L.; Lyell, D. J.; El-Sayed, Y. Y.; Carr, D. B.; Clark, A. L.; Abdullah Mahdy, Zaleha; Uma, M.; Sayin, N. C.; Varol, G. F.; Mol, B. W.; Oudijk, M. A.

In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 123, No. 11, 01.10.2016, p. 1753-1760.

Research output: Contribution to journalReview article

van Vliet, EOG, Dijkema, GH, Schuit, E, Heida, KY, Roos, C, van der Post, JAM, Parry, EC, McCowan, L, Lyell, DJ, El-Sayed, YY, Carr, DB, Clark, AL, Abdullah Mahdy, Z, Uma, M, Sayin, NC, Varol, GF, Mol, BW & Oudijk, MA 2016, 'Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 123, no. 11, pp. 1753-1760. https://doi.org/10.1111/1471-0528.14249
van Vliet, E. O G ; Dijkema, G. H. ; Schuit, E. ; Heida, K. Y. ; Roos, C. ; van der Post, J. A M ; Parry, E. C. ; McCowan, L. ; Lyell, D. J. ; El-Sayed, Y. Y. ; Carr, D. B. ; Clark, A. L. ; Abdullah Mahdy, Zaleha ; Uma, M. ; Sayin, N. C. ; Varol, G. F. ; Mol, B. W. ; Oudijk, M. A. / Nifedipine maintenance tocolysis and perinatal outcome : an individual participant data meta-analysis. In: BJOG: An International Journal of Obstetrics and Gynaecology. 2016 ; Vol. 123, No. 11. pp. 1753-1760.
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abstract = "Background: Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven. Objectives: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA). Search strategy: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour. Selection criteria: We selected trials including pregnant women between 24 and 366/7 weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment. Data collection and analysis: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed. Main results: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95{\%} confidence interval, 95{\%} CI 0.35–5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95{\%} CI 0.16–2.67), necrotising enterocolitis (NEC) (RR 1.15; 95{\%} CI 0.50–2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95{\%} CI 0.51–1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95{\%} CI 0.55–1.01). Conclusion: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice. Tweetable abstract: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.",
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TY - JOUR

T1 - Nifedipine maintenance tocolysis and perinatal outcome

T2 - an individual participant data meta-analysis

AU - van Vliet, E. O G

AU - Dijkema, G. H.

AU - Schuit, E.

AU - Heida, K. Y.

AU - Roos, C.

AU - van der Post, J. A M

AU - Parry, E. C.

AU - McCowan, L.

AU - Lyell, D. J.

AU - El-Sayed, Y. Y.

AU - Carr, D. B.

AU - Clark, A. L.

AU - Abdullah Mahdy, Zaleha

AU - Uma, M.

AU - Sayin, N. C.

AU - Varol, G. F.

AU - Mol, B. W.

AU - Oudijk, M. A.

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Background: Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven. Objectives: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA). Search strategy: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour. Selection criteria: We selected trials including pregnant women between 24 and 366/7 weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment. Data collection and analysis: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed. Main results: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35–5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16–2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50–2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51–1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55–1.01). Conclusion: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice. Tweetable abstract: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.

AB - Background: Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven. Objectives: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA). Search strategy: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour. Selection criteria: We selected trials including pregnant women between 24 and 366/7 weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment. Data collection and analysis: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed. Main results: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35–5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16–2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50–2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51–1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55–1.01). Conclusion: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice. Tweetable abstract: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.

KW - Individual participant data meta-analysis

KW - maintenance tocolysis

KW - nifedipine

KW - outcome

KW - preterm birth

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DO - 10.1111/1471-0528.14249

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