Skip to main content

Table 1 Planned assessments of the risk selection experiment: variables, methods and outcomes

From: Effectiveness of score card-based antenatal risk selection, care pathways, and multidisciplinary consultation in the Healthy Pregnancy 4 All study (HP4ALL): study protocol for a cluster randomized controlled trial

Patients

Variables

Methods

Outcomes

1. INTERVENTION GROUP

  

Nonmedical risk factors: 39 items from the risk scorecard, categorized into the domains of social, ethnicity, care, and lifestyle.

R4U scorecard + registration form ‘Obstetric history’

Primary outcomes:

- Preterm birth

- Small for gestational age

Medical risk factors: 30 items from the risk scorecard, categorized into the domains of general history and obstetric history

Questionnaire ‘Baseline characteristics’

Secondary outcomes - Undetected small for gestational age and unexpected preterm births (babies born in the first level of care)

Baseline characteristics: Age, zip code, ethnicity, onset of care, household composition, family income, employment, education level, smoking, alcohol, drugs, folic acid use, medication use, pre-existing chronic diseases, and sexually transmitted diseases.

Case Record Form ‘pregnancy and delivery data’

- Prevalence of risk factors

- Risk accumulation

- Involved healthcare professionals during pregnancy

- Detection and prevention of impaired growth and preterm birth during pregnancy

- Perinatal mortality

- Congenital anomalies

- Delivery modus

- Place of delivery

2. CONTROL GROUP

  

Baseline characteristics: Age, zip code, ethnicity, onset of care, household composition, family income, employment, education level, smoking, alcohol, drugs, folic acid use, medication use, pre-existing chronic diseases, and sexually transmitted diseases.

Registration form ‘Obstetric history’

- Asphyxia

Questionnaire ‘Baseline characteristics’ Case Record Form ‘pregnancy and delivery data’

- Neonatal admission

- Maternal morbidity (such as pre-existing chronic disease, pregnancy complications, positive booking bloods), and maternal mortality.

Patient satisfaction in both groups

Questionnaire ‘Patient experiences during the first antenatal visit’

- Which topics were discussed (10 examples)?

- What was your experience?

- Do you think this was important to ask?

Care providers

Variables

Methods

Outcomes

General characteristics participating midwives practices and hospitals in both groups

Interview-based questionnaire

- Current status number of patients and employees

- Use of risk selection instruments

- Collaboration with hospitals and (other) midwifery practices

- Work processes (for example, counseling for prenatal screening, or ultrasound facilities)

Care provider satisfaction in both groups

Questionnaire

- Feasibility

- Efficacy of implementation

- Collaboration

- Continuation of intervention