Healthy pregnancy 4 ALL - Preconception Care

This website aims to describe the study regarding preconception care. For more information about early antenatal risk assessment during pregnancy, the other study within the Healthy Pregnancy 4 All project, please visit our website www.erasmusmc.nl/HP4ALL.

Preconception Care and Risk Assessment during pregnancy
This site aims to describe the study regarding programmatic preconception care project within Healthy Pregnancy 4 All (HP4All). For more information about antenatal risk assessment project within this study visit the other link within the consortium or visit the projects own website: www.erasmusmc.nl/HP4ALL

Objective
Goals of the preconception care experiment are 1) to assess the efficacy of the program 2) to assess the extent to which the program succeeds in reaching high risk groups and 3) to identify factors that are associated with successful or unsuccessful implementation of programmatic preconception care.  Additional points of the program are inventarisation of the prevalence of preconceptional risk factors, introduction of Peer Educators Perinatal Health in municipalities and education on reproductive health and fertility.

Study design
The study design is prospective cohort study within 14 municipalities in the Netherlands. These 14 municipalities are selected as their average adverse perinatal health outcomes rank amongst the highest in the country.  The study focuses on women in postal zones with the highest perinatal adverse outcomes within the municipality itself.

Study population
Women contemplating pregnancy, between eighteen and forty-two years of age, in the selected neighborhoods are recruited for preconception care consultations.

Four parties contribute to recruitment of these women: Municipal Health Authorities, General Physicians, Children Health Welfare Centers and Peer Educators Perinatal Health.

Intervention
The intervention comprises individual preconception care consultation from a midwife or a general physician, using the existing tools:  ‘ZwangerWijzer’ and ‘PreconceptieWijzer.’ During the consultation the caregiver offers the patient a tailored preconception care plan to improve preconceptional health. This plan can consist of advices, complementary diagnostic procedure, referral or interventions regarding the identified risk factors. The consultation has a follow-up appointment after 3 months.

Outcome measures
Primary outcome measures regarding the efficacy of the program are: folic acid use, smoking cessation, cessation of alcohol consumption and substance use, adhering to safe medication advice, reaching a healthy BMI and avoidance of infection risks (e.g. litter box/ raw foods). These outcomes are assessed with self-reported outcomes and where possible with biomarkers. Secondary outcome measures are: commence of obstetric care within the first twelve weeks of pregnancy and incidence of adverse pregnancy outcomes (incidence of small for gestational age (birth weight < p10), preterm birth (<37 weeks), low Apgar score (<7 after 5 minutes) and perinatal mortality (subdivided in fetal and neonatal mortality)).

Participation and the outreach of the programme is assessed quantitatively and qualitatively with Andersen’s Model of Health Care Utilization. Organizational factors crucial for or disadvantaging successful implementation will be assessed.

Power/data analysis
We hypothesize that individual preconception care counseling can improve folic acid supplement use with >20 % (among non-users prior to consultation) and reduce smoking with > 5% (among smokers prior to consultation). Based on power calculation, the study aims to include n = 839 women (power: 1-β=0,8; α= 0,025 one-sided testing, based on self-reported outcomes, assuming a prevalence of folic acid of 30% and a prevalence of smoking 30% prior to consultation and a 10% drop out).

Economic evaluation
Time duration and costs per consultation will be monitored to form a foundation for a fare for preconception care in the future.

Time schedule
36 months.

Projectleaders
Prof. dr. E.A.P. Steegers, gynaecologist, Erasmus MC Rotterdam

Dr. S. Denktaş senior researcher, Erasmus MC Rotterdam

Drs. A.J.M. Waelput, midwife, Erasmus MC Rotterdam

Dr. L.C. de Jong-Potjer, general practitioner, Erasmus MC Rotterdam

Methodology
Not applicable

Subsidy
Ministry of Health, Welfare and Sports, Subsidy number 318804

Contact (researcher)

Drs. S.F. van Voorst, PhD candidate, Erasmus MC Rotterdam, s.vanvoorst@erasmusmc.nl