Trends in perinatal outcomes of women with chronic medical conditions: A 10-year population-based study in the Netherlands.

OBJECTIVE: To gain insight into perinatal outcomes in women with chronic medical conditions, in order to contribute to the optimization of personalized perinatal care. We hypothesize that women with a chronic medical condition have poorer perinatal outcomes than women without a known chronic medical condition. DESIGN: Population-based study using data of the Netherlands Perinatal Registry between 2010-2019. SETTING: Nationwide study in the Netherlands. PARTICIPANTS: Pregnancies of women who were diagnosed with chronic medical conditions by a medical specialist before pregnancy (n=36,835), divided into seven sub-groups and a reference group of pregnancies of women without known chronic medical conditions (n=1,084,623). MEASUREMENTS AND FINDINGS: The primary outcome measure was mode of birth. Secondary outcomes measures were onset of labour, preterm birth, asphyxia, Neonatal Intensive Care Unit (NICU) admission, and perinatal mortality. Spontaneous birth ranged from 45.0% (orthopaedic conditions) to 71.3% (neurological conditions) to 82.6% in the reference group. Assisted vaginal birth, planned caesarean birth, and emergency caesarean birth occurred significantly more in all groups compared to the reference group (p<0.001). Preterm birth was significantly more likely in the studied groups as well as perinatal asphyxia and NICU admission (all p<0.001). Adjusting for mode of birth, parity, age and ethnicity did not change the outcomes for the group of women with chronic medical conditions. Perinatal mortality was seen in all groups but in none of the separate groups significantly more than in the reference group. Descriptive statistics, univariate and multivariable logistic regression analyses were applied. KEY CONCLUSIONS: Women with chronic medical conditions are more likely to experience preterm birth, caesarean births and NICU admission of the new-born. IMPLICATIONS FOR PRACTICE: Knowledge about perinatal outcomes of women with chronic medical conditions is a first step for obstetrics care providers in order to optimize personalized care.

Seasonality of depressive symptoms during pregnancy.

Various risk factors have been identified for antepartum depression. This study evaluated seasonal influences on antepartum depressive symptoms. Data of 2,438 pregnant women on current depressive symptoms was obtained from a large-scale cross-sectional study in The Netherlands. Most women were screened during the first trimester. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) and dichotomized using ≥ 9 as cut-off score. The seasonal relationship between antepartum depressive symptoms and the month of assessment was estimated by fitting a sinusoidal curve to the data. A total of 323 women (13.2%) scored above cut-off. In the full sample, we found no significant evidence for seasonal influences on depressive symptoms after adjusting for confounders. Additionally, we found that the seasonal influence was obscured by the modification of the effect by current treatment status. In women untreated for psychiatric complaints, we found a minimum of depressive symptomatology in September and a maximum in March. In women treated for psychiatric complaints we found a minimum of depressive symptomatology in December and a maximum in June. Thus, the effects of seasonality are apparent, but opposite in treated and untreated women. However, health professionals should be aware of depressive symptoms the whole year through.

Bright light therapy in pregnant women with major depressive disorder: study protocol for a randomized, double-blind, controlled clinical trial.

BACKGROUND: Depression during pregnancy is a common and high impact disease. Generally, 5-10 % of pregnant women suffer from depression. Children who have been exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes and more often show cognitive, emotional and behavioural problems. Therefore, early detection and treatment of antepartum depression is necessary. Both psychotherapy and antidepressant medication, first choice treatments in a non-pregnant population, have limitations in treating depression during pregnancy. Therefore, it is urgent and relevant to investigate alternative treatments for antepartum depression. Bright light therapy (BLT) is a promising treatment for pregnant women with depressive disorder, for it combines direct availability, sufficient efficacy, low costs and high safety, taking the safety for the unborn child into account as well. METHODS: In this study, 150 pregnant women (12-18 weeks pregnant) with a DSM-V diagnosis of depressive disorder will be randomly allocated in a 1:1 ratio to one of the two treatment arms: treatment with BLT (9.000 lux) or treatment with dim red light therapy (100 lux). Both groups will be treated for 6 weeks at home on a daily basis for 30 min, within 30 min of habitual wake-up time. Follow-up will take place after 6 weeks of therapy, 3 and 10 weeks after end of therapy, at birth and 2, 6 and 18 months postpartum. Primary outcome will be the average change in depressive symptoms between the two groups, as measured by the Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder version and the Edinburg Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time will be analysed using generalized linear mixed models. Secondary outcomes will be the changes in maternal cortisol and melatonin levels, in maternal sleep quality and gestational age, birth weight, infant behaviour, infant cortisol exposure and infant cortisol stress response. DISCUSSION: If BLT reduces depressive symptoms in pregnant women, it will provide a safe, cheap, non-pharmacological and efficacious alternative treatment for psychotherapy and antidepressant medication in treating antepartum depression, without any expected adverse reactions for the unborn child. TRIAL REGISTRATION: Netherlands Trial Register NTR5476 . Registered 5 November 2015.

Vulnerable pregnant women in antenatal practice: Caregiver's perception of workload, associated burden and agreement with objective caseload, and the influence of a structured organisation of antenatal risk management.

INTRODUCTION: pregnancy care for vulnerable women is often perceived as a burden by caregivers as vulnerable clients require complex case management, additional time, and more often show adverse perinatal outcomes. Vulnerable clients bring about additional work strain for the caregiver, especially when the workload is high. We define client vulnerability as coexistence of psychopathology, psychosocial problems or substance use, together with features of deprivation. We investigated, as part of a national programme, whether the subjective caregiver's perception of workload and the objective registry-based caseload of vulnerable clients are in agreement, and whether a structured organisation of antenatal risk management reduces the burden associated with the perceived workload, in particular if the objective caseload is high. METHODS: we combined three data sources: (1) at the unit level (i.e. midwifery practice, obstetric unit) interview data from caregivers, from which we derived a) the (subjective) caregiver's perception of workload, b) the associated burden and c) organisational structure of antenatal risk management, (2) at the unit level perinatal registry data, from which we derived a) unit characteristics and b) (objective) unit specific caseload, and (3) at the individual client level survey data collected during the first antenatal visit, from which the prevalence of vulnerable clients was derived. The study area was the South-West Netherlands (2.5 million inhabitants), containing areas with varying degrees of urbanisation and deprivation. FINDINGS: sixteen units had complete data on all measures. Generally, subjective workload and objective caseload were only weakly related, the relation being modified by the organisation of antenatal risk management. If the organisational structure of antenatal risk management was low, the experienced burden was high, even if the objective caseload was low. Highly structured antenatal risk management was associated with a medium to low burden. DISCUSSION: our observational study suggests that even a high caseload can be dealt with by structured antenatal risk management. A change from the current individual case-finding policies towards a more universal screen-like approach may thus benefit both the client and the caregiver.

Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial.

BACKGROUND: Approximately 6.2 % of women in the USA and 3.7 % of women in the UK, use Selective Serotonin Reuptake Inhibitors (SSRIs) during their pregnancies because of depression and/or anxiety. In the Netherlands, this prevalence is around 2 %. Nonetheless, SSRI use during pregnancy is still controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse or recurrence of depression during pregnancy poses risks for both mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions regarding continuation or tapering of SSRIs during pregnancy. At present, no such studies exist. METHODS/DESIGN: 'Stop or Go' is a pragmatic multicentre randomized non-inferiority trial among 200 pregnant women with a gestational age of less than 16 weeks who use SSRIs without clinically relevant depressive symptoms. Women allocated to the intervention group will receive preventive cognitive therapy with gradual, guided discontinuation of SSRIs under medical management (STOP). Women in the control group will continue the use of SSRIs (GO). Primary outcome will be the (cumulative) incidence of relapse or recurrence of maternal depressive disorder (as assessed by the Structured Clinical Interview for DSM disorders) during pregnancy and up to three months postpartum. Secondary outcomes will be child outcome (neonatal outcomes and psychomotor and behavioural outcomes up to 24 months postpartum), and health-care costs. Total study duration for participants will be therefore be 30 months. We specified a non-inferiority margin of 15 % difference in relapse risk. DISCUSSION: This study is the first to investigate the effect of guided tapering of SSRIs with preventive cognitive therapy from early pregnancy onwards as compared to continuation of SSRIs during pregnancy. We will study the effects on both mother and child with a pragmatic approach. Additionally, the study examines cost effectiveness. If non-inferiority of preventive cognitive therapy with guided tapering of SSRIs compared to intended continuation of SSRIs is demonstrated for the primary outcome, this may be the preferential strategy during pregnancy. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR4694 ; registration date: 16-jul-2014.

Feasibility and reliability of a newly developed antenatal risk score card in routine care.

OBJECTIVE: to study in routine care the feasibility and inter-rater reliability of the Rotterdam Reproductive Risk Reduction risk score card (R4U), a new semi-quantitative score card for use during the antenatal booking visit. The R4U covers clinical and non-clinical psychosocial factors and identifies overall high risk pregnancies, qualifying for intensified antenatal care. DESIGN: a population-based cross-sectional study (feasibility) and a cohort study (inter-rater reliability). SETTING: feasibility was studied in six midwifery practices and two hospitals; the reliability study was performed in one midwifery practice. PARTICIPANTS: 1096 pregnant women in the feasibility study and a subsample of 133 participants in the inter-rater reliability study. MEASUREMENTS: feasibility was expressed as (a) time needed to complete the R4U and (b) the missing rate at the item and client level. For inter-rater reliability (IRR) an independent, blinded, caregiver completed a re-test R4U during a second visit; inter-rater agreement for each item and all domain sum scores were computed. FINDINGS: completion of the R4U took 5 minutes or less in 63%; and between 5 and 10 minutes in another 33%. On the participant level 0.2% of women had >20% missing values (below 4% threshold, P<0.001). One of 77 items had a >10% missing rate. The per item IRR was 100% in 20% of the items, and below the predefined 80% threshold in 13% of the items (n=9). The domain sum scores universally differed less than the predetermined ±15% margin. KEY CONCLUSION: the R4U risk score card is a feasible and reliable instrument. IMPLICATION FOR PRACTICE: the R4U is suitable for the assessment of clinical and non-clinical risks during the antenatal booking visit in a heterogeneous urban setting in routine practice.