Impact of a randomized trial on maintenance tocolysis on length of hospital admission of women with threatened preterm labor in The Netherlands

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Abstract

Introduction

The APOSTEL-II trial was a multicenter randomized placebo-controlled trial, assessing the effectiveness of maintenance tocolysis with nifedipine. The trial showed maintenance tocolysis not to have an effect on perinatal outcome. Objective of the current study is to evaluate the effect of a negative trial on the length of hospital admission of women with threatened preterm labor.

Materials and methods

We evaluated length of hospital admission of all patients admitted with threatened preterm labor with a gestational age <32 weeks in 8 perinatal centers that participated in the APOSTEL-II trial. We studied only the first admission with threatened preterm labor, readmissions were excluded. We distinguished between the period before, the period during and the period after the trial. In a subgroup analysis, we differentiated for the group of women who delivered and for the group of women who did not deliver during the initial admission.

Results

The mean length of hospital admission was 9.3 days before the start of the trial, 8.4 days during the recruitment period and 8.1 days after the trial was completed. The difference in mean length of hospital admission before and during the recruitment period was significantly different (p < 001).

Comments

The length of hospital admission of women with threatened preterm labor is found to be reduced during the recruitment period of the APOSTEL-II trial. This shows that the conduct of a randomized controlled trial itself has the potential to change daily practice.

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.

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