The Usability and Effectiveness of Mobile Health Technology-Based Lifestyle and Medical Intervention Apps Supporting Health Care During Pregnancy: Systematic Review.

BACKGROUND: A growing number of mobile health (mHealth) technology-based apps are being developed for personal lifestyle and medical health care support, of which several apps are related to pregnancy. Evidence on usability and effectiveness is limited but crucial for successful implementation. OBJECTIVE: This study aimed to evaluate the usability, that is, feasibility and acceptability, as well as effectiveness of mHealth lifestyle and medical apps to support health care during pregnancy in high-income countries. Feasibility was defined as the actual use, interest, intention, and continued use; perceived suitability; and ability of users to carry out the activities of the app. Acceptability was assessed by user satisfaction, appreciation, and the recommendation of the app to others. METHODS: We performed a systematic review searching the following electronic databases for studies on mHealth technology-based apps in maternal health care in developed countries: EMBASE, MEDLINE Epub (Ovid), Cochrane Library, Web of Science, and Google Scholar. All included studies were scored on quality, using the ErasmusAGE Quality Score or the consolidated criteria for reporting qualitative research. Main outcome measures were usability and effectiveness of mHealth lifestyle and medical health care support apps related to pregnancy. All studies were screened by 2 reviewers individually, and the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement were followed. RESULTS: Our search identified 4204 titles and abstracts, of which 2487 original studies remained after removing duplicates. We performed full-text screening of 217 studies, of which 29 were included in our study. In total, 19 out of 29 studies reported on mHealth apps to adopt healthy lifestyles and 10 out of 29 studies to support medical care. The lifestyle apps evaluated in 19 studies reported on usability and effectiveness: 10 studies reported positive on acceptability, and 14 studies reported on feasibility with positive results except one study. In total, 4 out of 19 studies evaluating effectiveness showed significant results on weight gain restriction during pregnancy, intake of vegetables and fruits, and smoking cessation. The 10 studies on medical mHealth apps involved asthma care, diabetic treatment, and encouraging vaccination. Only one study on diabetic treatment reported on acceptability with a positive user satisfaction. In total, 9 out of 10 studies reported on effectiveness. Moreover, the power of most studies was inadequate to show significant effects. CONCLUSIONS: Most studies on mHealth apps to support lifestyle and medical care for high-income countries reveal the usability of these apps to reduce gestational weight gain, increase intakes of vegetables and fruit, to quit smoking cessation, and to support health care for prevention of asthma and infections during pregnancy. In general, the evidence on effectiveness of these apps is limited and needs further investigation before implementation in medical health care.

Nifedipine versus placebo in the treatment of preterm prelabor rupture of membranes: a randomized controlled trial: Assessment of perinatal outcome by use of tocolysis in early labor-APOSTEL IV trial.

OBJECTIVE: Preterm birth is the most common cause of neonatal morbidity and mortality. Around one third of preterm deliveries starts with preterm prelabor rupture of membranes (PPROM). The aim of this trial was to study the effect of prolonged tocolysis with nifedipine versus placebo in women with PPROM on perinatal outcome and prolongation of pregnancy. STUDY DESIGN: The Apostel IV was a nationwide multicenter randomized placebo controlled trial. We included women with PPROM without contractions between 24(+0) and 33(+6) weeks of gestation. Participants were randomly allocated to daily 80mg nifedipine or placebo, until the start of labor, with a maximum of 18 days. The primary outcome measure was a composite of poor neonatal outcome, including perinatal death, bronchopulmonary dysplasia, periventricular leukomalacia>grade 1, intraventricular hemorrhage>grade 2, necrotizing enterocolitis>stage 1 and culture proven sepsis. Secondary outcomes were gestational age at delivery and prolongation of pregnancy. Analysis was by intention to treat. To detect a reduction of poor neonatal outcome from 30% to 10%, 120 women needed to be randomized. TRIAL REGISTRY: NTR 3363. RESULTS: Between October 2012 and December 2014 we randomized 25 women to nifedipine and 25 women to placebo. Due to slow recruitment the study was stopped prematurely. The median gestational age at randomization was 29.9 weeks (IQR 27.7-31.3) in the nifedipine group and 27.0 weeks (IQR 24.7-29.9) in the placebo group. Other baseline characteristics were comparable. The adverse perinatal outcome occurred in 9 neonates (33.3%) in the nifedipine group and 9 neonates (32.1%) in the placebo group (RR 1.04, 95% CI 0.49-2.2). Two perinatal deaths occurred, both in the nifedipine group. Bronchopulmonary dysplasia was seen less frequently in the nifedipine group (0% versus 17.9%; p=0.03). Prolongation of pregnancy did not differ between the nifedipine and placebo group (median 11 versus 8 days, HR 1.02; 95% CI 0.58-1.79). CONCLUSION: This randomized trial did not show a beneficial effect of prolonged tocolysis on neonatal outcomes or prolongation of pregnancy in women with PPROM without contractions. However, since results are based on a small sample size, a difference in effectiveness cannot be excluded.

Tobacco control policies and perinatal health: a national quasi-experimental study.

We investigated whether changes in perinatal outcomes occurred following introduction of key tobacco control policies in the Netherlands: smoke-free legislation in workplaces plus a tobacco tax increase and mass media campaign (January-February 2004); and extension of the smoke-free law to the hospitality industry, accompanied by another tax increase and mass media campaign (July 2008). This was a national quasi-experimental study using Netherlands Perinatal Registry data (2000-2011; registration: ClinicalTrials.gov NCT02189265). Primary outcome measures were: perinatal mortality, preterm birth, and being small-for-gestational age (SGA). The association with timing of the tobacco control policies was investigated using interrupted time series logistic regression analyses with adjustment for confounders. Among 2,069,695 singleton births, there were 13,027 (0.6%) perinatal deaths, 116,043 (5.6%) preterm live-births and 187,966 (9.1%) SGA live-births. The 2004 policies were not associated with significant changes in the odds of developing any of the primary outcomes. After the 2008 policy change, a -4.4% (95% CI -2.4; -6.4, p < 0.001) decrease in odds of being SGA was observed. A reduction in SGA births, but not preterm birth or perinatal mortality, was observed in the Netherlands after extension of the smoke-free workplace law to bars and restaurants in conjunction with a tax increase and mass media campaign.

Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial.

BACKGROUND: In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. METHODS: We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. FINDINGS: Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0·91, 95% CI 0·61-1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91-5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. INTERPRETATION: In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes. FUNDING: ZonMw (the Netherlands Organisation for Health Research and Development).

Preterm birth in singleton and multiple pregnancies: evaluation of costs and perinatal outcomes.

OBJECTIVE: To estimate costs of preterm birth in singleton and multiple pregnancies. STUDY DESIGN: Cost analysis based on data from a prospective cohort study and three multicentre randomised controlled trials (2006-2012) in a Dutch nationwide consortium for women's health research. Women with preterm birth before 37 completed weeks were included for analysis. Direct costs were estimated from a health care perspective, from delivery until discharge or decease of the neonates. Costs and adverse perinatal outcome per pregnancy were measured. Adverse perinatal outcome comprised both perinatal mortality and a composite of neonatal morbidity defined as chronic lung disease, intraventricular haemorrhage≥grade 2, periventricular leukomalacia≥grade 1, proven sepsis or necrotising enterocolitis. Using a moving average technique covering three weeks per measurement, costs and adverse perinatal outcome per woman delivering for every week between 24 and 37 weeks are reported. RESULTS: Data of 2802 women were available of whom 1503 (53.6%) had a preterm birth; 501 in 1090 singleton (46%) and 1002 in 1712 multiple pregnancies (58.5%). The most frequent perinatal outcomes were perinatal mortality, chronic lung disease and sepsis. For singleton pregnancies the peak of total costs was at 25 weeks (€88,052 per delivery), compared to 27 weeks for multiple pregnancies (€169,571 per delivery). The total costs declined rapidly with increasing duration of pregnancy. Major cost drivers were length of stay on the NICU and airway treatments. The peaks seen in costs paralleled with the prevalence of adverse perinatal outcome. CONCLUSIONS: These data can be used to elaborate on the impact of preterm birth in case only data are available on duration of pregnancy.