Associations of severe adverse perinatal outcomes among continuous birth weight percentiles on different birth weight charts: a secondary analysis of a cluster randomized trial.

OBJECTIVE: To identify neonatal risk for severe adverse perinatal outcomes across birth weight centiles in two Dutch and one international birth weight chart. BACKGROUND: Growth restricted newborns have not reached their intrinsic growth potential in utero and are at risk of perinatal morbidity and mortality. There is no golden standard for the confirmation of the diagnosis of fetal growth restriction after birth. Estimated fetal weight and birth weight below the 10th percentile are generally used as proxy for growth restriction. The choice of birth weight chart influences the specific cut-off by which birth weight is defined as abnormal, thereby triggering clinical management. Ideally, this cut-off should discriminate appropriately between newborns at low and at high risk of severe adverse perinatal outcomes and consequently correctly inform clinical management. METHODS: This is a secondary analysis of the IUGR Risk Selection (IRIS) study. Newborns (n = 12 953) of women with a low-risk status at the start of pregnancy and that received primary antenatal care in the Netherlands were included. We examined the distribution of severe adverse perinatal outcomes across birth weight centiles for three birth weight charts (Visser, Hoftiezer and INTERGROWTH) by categorizing birth weight centile groups and comparing the prognostic performance for severe adverse perinatal outcomes. Severe adverse perinatal outcomes were defined as a composite of one or more of the following: perinatal death, Apgar score < 4 at 5 min, impaired consciousness, asphyxia, seizures, assisted ventilation, septicemia, meningitis, bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukomalacia, or necrotizing enterocolitis. RESULTS: We found the highest rates of severe adverse perinatal outcomes among the smallest newborns (< 3rd percentile) (6.2% for the Visser reference curve, 8.6% for the Hoftiezer chart and 12.0% for the INTERGROWTH chart). Discriminative abilities of the three birth weight charts across the entire range of birth weight centiles were poor with areas under the curve ranging from 0.57 to 0.61. Sensitivity rates of the various cut-offs were also low. CONCLUSIONS: The clinical utility of all three charts in identifying high risk of severe adverse perinatal outcomes is poor. There is no single cut-off that discriminates clearly between newborns at low or high risk. TRIAL REGISTRATION: Netherlands Trial Register NTR4367 . Registration date March 20th, 2014.

Chlamydia trachomatis, Neisseria gonorrhoea, and Trichomonas vaginalis infections among pregnant women and male partners in Dutch midwifery practices: prevalence, risk factors, and perinatal outcomes.

BACKGROUND: Antenatal screening for HIV, syphilis and HBV has been successfully implemented in The Netherlands, but data on other STI among pregnant women or male partners are limited. Our objectives: (i) to assess the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) among pregnant women and male partners, (ii) to identify risk factors for these STI during pregnancy, and (iii) to identify adverse perinatal outcomes (APO) associated with STI. METHODS: Cross-sectional study. Pregnant women aged ≤ 30 years (n = 548) and male partners (n = 425) were included at 30 midwifery practices during 2012-2016. Participants provided a self-collected vaginal swab (women) or urine sample (men) and completed a questionnaire. Perinatal data were derived from pregnancy cards. APO was defined as premature rupture of membranes, preterm delivery, low birthweight, stillbirth, neonatal conjunctival and respiratory infections. Data were analysed by logistic regression. RESULTS: STI were present in 2.4% of pregnant women (CT 1.8%, NG 0.4%, TV 0.4%), and in 2.2% of male partners (CT 2.2%, NG 0.2%, TV 0%). Of young women (≤ 20 years), 12.5% had a CT infection. Prevalent STI during pregnancy was associated with female young age (≤ 20 years vs ≥ 21 years) (adjusted OR 6.52, CI 95%: 1.11-38.33), male non-Western vs Western background (aOR 9.34, CI 2.34-37.21), and female with ≥ 2 sex partners < 12 months vs 0-1 (aOR 9.88, CI 2.08-46.91). APO was not associated with STI, but was associated with female low education (aOR 3.36, CI 1.12-10.09), complications with previous newborn (aOR 10.49, CI 3.21-34.25 vs no complications) and short duration (0-4 years) of relationship (aOR 2.75, CI 1.41-5.39 vs ≥ 5 years). Small-for-gestational-age was not associated with STI, but was associated with female low education (aOR 7.81, 2.01-30.27), female non-Western background (aOR 4.41, 1.74-11.17), and both parents smoking during pregnancy (aOR 2.94, 1.01-8.84 vs both non-smoking). CONCLUSIONS: Prevalence of STI was low among pregnant women and male partners in midwifery practices, except for CT among young women. The study could not confirm previously observed associations between STI and APO, which is probably due to low prevalence of STI, small study sample, and presumed treatment for STI.

Antenatal screening for HIV, syphilis and HBV has been successfully implemented in The Netherlands, but data on other STI among pregnant women or male partners are limited. Our objectives were: (i) to assess the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) among pregnant women and male partners, (ii) to identify risk factors for these STI during pregnancy, and (iii) to identify adverse perinatal outcomes (APO) associated with STI.Pregnant women aged ≤ 30 years and male partners were included at 30 midwifery practices. Women provided a vaginal swab, partners a urine sample; both completed a questionnaire. Perinatal data were derived from midwives.STI were present in 2.4% of pregnant women (CT 1.8%, NG 0.4%, TV 0.4%), and in 2.2% of male partners (CT 2.2%, NG 0.2%, TV 0%). Of women ≤ 20 years, 12.5% had a CT infection. Prevalent STI during pregnancy was associated with female young age, male non-Western background, and female with ≥ 2 sex partners < 12 months. APO was not associated with STI, but was associated with female low education, complications with previous newborn, and short duration of the relationship. Small-for-gestational-age was not associated with STI, but was associated with female low education, female non-Western background, and both parents smoking during pregnancy.Prevalence of STI was low among pregnant women and male partners in midwifery practices, except for CT among young women. The study could not confirm previously observed associations between STI and APO. Probably due to low prevalence of STI, small study sample, and presumed treatment for STI.

Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial.

OBJECTIVES: To investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions. DESIGN: Pragmatic, multicentre, stepped wedge cluster randomised trial. SETTING: 60 midwifery practices in the Netherlands. PARTICIPANTS: 13 046 women aged 16 years or older with a low risk singleton pregnancy. INTERVENTIONS: 60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks' gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies. MAIN OUTCOME MEASURES: The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. RESULTS: Between 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks' gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. CONCLUSION: In low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies. TRIAL REGISTRATION: Netherlands Trial Register NTR4367.

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study).

BACKGROUND: Intrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management. METHODS: For this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28-30 weeks and 34-36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial. The primary dichotomous clinical composite outcome is 'severe adverse perinatal outcome' up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them. DISCUSSION: The results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography. TRIAL REGISTRATION: NTR4367 , 21 March 2014.

Continuity of care: what matters to women when they are referred from primary to secondary care during labour? a qualitative interview study in the Netherlands.

BACKGROUND: Continuity of care during labour is important for women. Women with an intrapartum referral from primary to secondary care look back more negatively on their birh experience compared to those who are not referred. It is not clear which aspects of care contribute to this negative birth experience. This study aimed to explore in-depth the experiences of women who were referred during labour from primary to secondary care with regard to the different aspects of continuity of care. METHODS: A qualitative interview study was conducted in the Netherlands among women who were in primary care at the onset of labour and were referred to secondary care before the baby was born. Through purposive sampling 27 women were selected. Of these, nine women planned their birth at home, two in an alongside midwifery unit and 16 in hospital. Thematic analysis was used. RESULTS: Continuity of care was a very important issue for women because it contributed to their feeling of safety during labour. Important details were sometimes not handed over between professionals within and between primary and secondary care, in particular about women's personal preferences. In case of referral of care from primary to secondary care, it was important for women that midwives handed over the care in person and stayed until they felt safe with the hospital team. Personal continuity of care, in which case the midwife stayed until the end of labour, was highly appreciated but not always expected.Fear of transportion during or after labour was a reason for women to choose hospital birth but also to opt for home birth. Choice of place of birth emerged as a fluid concept; most women planned their place of birth during pregnancy and were aware that they would spend some time at home and possibly some time in hospital. CONCLUSIONS: In case of referral from primary to secondary care during labour, midwives should hand over their care in person and preferrably stay with women throughout labour. Planned place of birth should be regarded as a fluid concept rather than a dichotomous choice.

Factors associated with not using folic acid supplements preconceptionally.

OBJECTIVE: Neural tube defects are among the most common birth defects worldwide. Folic acid intake from one month before to three months after conception reduces the likelihood of neural tube defects by at least 50%. Since 1995, several campaigns have been organised in the Netherlands which resulted in 51% of pregnant women using folic acid supplements during the entire recommended period in the northern part of the Netherlands in 2005. Our research question was to gain insight into the current prevalence and factors associated with inadequate pregnancy-related use of folic acid supplements. DESIGN: Data from the DELIVER study were used, which is a population-based cohort study. SETTING: Twenty midwifery practices across the Netherlands in 2009 and 2010. SUBJECTS: In total 5975 pregnant women completed a questionnaire covering items on sociodemographic and lifestyle factors, including folic acid intake. RESULTS: Of our study population, 55·5% (3318/5975) used folic acid supplements before conception. Several sociodemographic and lifestyle factors were associated with no preconception use of folic acid, of which non-Western ethnicity and not having a partner had the largest effect size. CONCLUSIONS: In the Netherlands, the folic acid intake before conception is suboptimal and has not improved over recent years. Fortification of staple foods with folic acid should be reconsidered as it would provide a more effective means of ensuring an adequate intake, especially for those groups of women who are unlikely to plan their pregnancies or to receive or respond to health promotion messages.

Socio-demographic and lifestyle-related characteristics associated with self-reported any, daily and occasional smoking during pregnancy.

Smoking during pregnancy is a risk factor for various adverse birth outcomes. In order to develop effective interventions, insight is needed into the characteristics associated with pregnant women who smoke. Unknown is whether these characteristics differ for women who smoke daily and women who smoke occasionally. Our study sample, drawn from the DELIVER study (Sept 2009-March 2011), consisted of 6107 pregnant women in primary care in the Netherlands who were up to 34 weeks pregnant. The associations of thirteen socio-demographic or lifestyle-related characteristics with 'any smoking', 'daily smoking' and 'occasional smoking' during pregnancy were tested using multiple binary logistic regression with general estimating equations (GEE). Characteristics most strongly associated with any smoking were low education (OR 10.3; 95% confidence interval (CI) 7.0-15.4), being of Turkish ethnicity (OR 3.9; 95%CI 2.3-6.7) and having no partner (OR 3.7; 95%CI 2.3-6.0). Women of Dutch ethnicity were three times more likely to smoke than those from Dutch-speaking Caribbean countries and non-religious women were much more likely to smoke than religious women. Low education was markedly more strongly associated with daily smoking than with occasional smoking (OR 20.3; 95%CI 13.2-31.3 versus OR 6.0; 95%CI 3.4-10.5). Daily smokers were more likely to be associated with other unfavorable lifestyle-related characteristics, such as not taking folic acid, being underweight, and having had an unplanned pregnancy. There is still much potential for health gain with respect to smoking during pregnancy in the Netherlands. Daily and occasional smokers appear to differ in characteristics, and therefore possibly require different interventions.