European Journal of Obstetrics & Gynecology and Reproductive Biology
Impact of a randomized trial on maintenance tocolysis on length of hospital admission of women with threatened preterm labor in The Netherlands
Introduction
Preterm birth is the most common cause of neonatal morbidity and mortality worldwide. Annually it affects 12,000 children in The Netherlands, of whom 2000 are born extremely premature (<32 weeks of gestation) [1]. Preterm birth is responsible for approximately 75% of all neonatal deaths [2] and 40% of childhood neurological morbidities. There is an increased risk of lifelong health consequences such as breathing disorders and developmental problems. Prematurity therefore has a major impact on the infant itself as well as the parents. In addition to the health consequences of prematurity, short term and long term costs are substantial [3]. However, no consensus existed in the past in daily obstetrical practice on the length of tocolytic therapy and a strong practice variation existed in The Netherlands for treatment of women with threatened preterm labor. Some obstetricians maintained tocolytic therapy until term – i.e. 37 weeks’ gestational age –, whereas others stopped tocolytics after 48 h irrespective of gestational age while others continued until for example 28 weeks’ gestational age.
This discrepancy regarding the length of tocolytic treatment in women with threatened preterm labor, set the stage for performing the APOSTEL-II (assessment of perinatal outcome with sustained tocolysis in early labor) trial [4]. In this prospective randomized multicenter placebo-controlled trial, women admitted for threatened preterm labor who were treated with 48 h tocolysis and corticosteroids, were allocated to nifedipine (intervention) or placebo (control) for twelve days. The results of the study are presented elsewhere [5].
Our objective was to evaluate whether participation in a randomized controlled trial on maintenance tocolysis with nifedipine influenced the duration of hospital admission of women with threatened preterm labor, in order to evaluate the effect of a negative trial on this outcome. To do so, we studied duration of hospital stay before, during and after the recruitment period.
Section snippets
Materials and methods
The APOSTEL-II trial was performed between June 2008 and February 2010 in 11 centers in The Netherlands. Data concerning the length of hospital admission were obtained from the Obstetric High Care (OHC) registry from 2006 to 2011, provided by 8 perinatal centers participating in the APOSTEL-II trial. For this retrospective study, we included hospital stays of all patients admitted with threatened preterm labor with a gestational age<32 weeks, whether they participated in the randomized study or
Results
The fixed number of days per period for all centers was 882 days for the period before the trial, 486 days for the period during the trial and 334 days for the period after the trial.
Table 1 shows the mean length of hospital admission in 3370, 1934 and 1185 women admitted with threatened preterm labor before, during and after the trial, respectively. The mean length of hospital admission was 9.3 days before versus 8.4 days during the trial (decreased 0.86 days, p < 0.001). There was no
Comments
The results of this retrospective study show that the APOSTEL-II trial reduced the duration of hospital admission of women with threatened preterm labor. There was a significant reduction of 0.86 days in mean length of hospital admission during the trial compared with the period before the trial. The start of this downward trend in mean length of hospital admission coincides with the moment of start of the APOSTEL-II trial. Possibly, a change in doctors’ behavior causes this reduction. When
Condensation
Length of admission of women with threatened preterm labor is reduced after participation in a randomized trial on maintenance tocolysis with nifedipine.
References (11)
- et al.
Epidemiology and causes of preterm birth
Lancet
(2008) - et al.
From best evidence to best practice: effective implementation of change in patients’ care
Lancet
(2003) Stichting Perinatale Registratie Nederland
(2009)- et al.
A structured review of the recent literature on the economic consequences of preterm birth
Arch Dis Child Fetal Neonatal Ed
(2011) - et al.
Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial)
BMC Pregnancy Childbirth
(2009)
Cited by (5)
Maintenance tocolysis: a reappraisal of clinical evidence
2019, Archives of Gynecology and ObstetricsEconomic consequences of over-diagnosis of threatened preterm labor
2018, International Journal of Gynecology and ObstetricsAcute Tocolysis - A Critical Analysis of Evidence-Based Data
2018, Geburtshilfe und FrauenheilkundeEffectiveness of the contemporary treatment of preterm labor: a comparison with a historical cohort
2017, Archives of Gynecology and ObstetricsComparison of risk of preterm labor between vaginal progesterone and17-alpha-hydroxy-progesterone caproate in women with threatened abortion: A randomized clinical trial
2016, International Journal of Fertility and Sterility