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Table 1 Definition of primary and secondary outcomes of the APROPOS-II study

From: Study design of a stepped wedge cluster randomized controlled trial to evaluate the effect of a locally tailored approach for preconception care – the APROPOS-II study

 VariableDefinition*
Pregnancy preparationLevel of pregnancy planningLondon Measure of Unplanned Pregnancies (LMUP) [21]
PCC health seeking behaviourAcquired PCC-information through the internet, books, journals, folders or family & friends.
PCC-consultA consultation provided by a healthcare provider.
Modifying lifestyle behaviours & risk factorsFruit intake≥ 2 pieces of fruit a day [22]
Vegetable intake≥ 200 g of vegetables a day [22]
Caffeine intake≤ 1 caffeine-containing beverage [22]
Exercising≥ 150 min per week moderate or heavy intensive exercise, spread over various days [23]
SmokingNo smoking [5, 24]
Alcohol intakeNo alcohol intake [5, 24]
Folic acid usage≥400 microgram per day, 4 weeks preconceptionally until 10 weeks gestation [5, 24]
Medication usageRisk-free medication [5]
Psychological distressA stable emotional state [5]
Vaccination statusVaccination status should be discussed with special attention to rubella, measles and whooping cough. Based on individual assessment of antibody titres; (re)vaccinations can be considered [24]
Working conditionsAvoid contact with harmful working conditions [5]
Prenatal outcomesMiscarriageLoss of pregnancy before 24 weeks [25].
Gestational Diabetes (GDM)Diagnosed by a 75-g oral glucose tolerance test (OGTT) as the presence of either a fasting glucose level of ≥7.0 mmol/L (126 mg/dl) or a glucose level of ≥7.8 mmol/L (140 mg/dl) after two hours [26, 27]
Pregnancy-induced hypertension (PIH)New onset of hypertension (≥ 140 mmHg systolic and/or ≥ 90 mmHg diastolic blood pressure) after 20 weeks gestation measured on at least two occasions four hours apart [28, 29]
Pre-eclampsia (PE)PIH accompanied by proteinuria (≥300 mg in 24 h) [29, 30]
Spontaneous preterm birthDelivery with spontaneous onset before 37 weeks of gestation [31].
Referral to secondary careIf complications occur or threaten to occur, the midwife will refer the woman to the obstetrician who will take over the care for as long as deemed necessary [32].
Birth outcomesMode of deliverySpontaneous vaginal delivery, assisted vaginal delivery, or caesarean section [33].
Referral to secondary careIf complications occur or threaten to occur, the midwife will refer the woman to the obstetrician who will take over the care for as long as deemed necessary [32].
Neonatal outcomesSmall for gestational age (SGA)Birth weight < 10th percentile, based on Dutch national reference curves adjusted for parity, gestational age, sex and ethnicity [34].
Congenital anomaliesStructural-morphological, functional and/or biochemical-molecular defects
present at birth [35].
APGAR- scoreA score is a sum of the values assigned to the infant at 1 and 5 min of life, with a score of 7 or more indicating that the baby is in good to excellent condition [36].
  1. * Definitions are based on Dutch standards