Table 3 Primary and all secondary outcomes at the individual level with definitions and timing of assessment
Outcomes | Postpartum period | |
Early (1–2 weeks after childbirth) | Late (6–12 weeks after childbirth) | |
Primary | Maternal empowerment | |
Definition | Low empowerment score (no/yes) defined as a score beneath the 20th centile within the control group | |
Assessment | Maternal Empowerment Questionnaire (MEQ). Overall scoring based on the median score across the following four domains; “Looking after yourself”, “My baby”, “My family”, “The future”. Values per question: 1 “Never” 2 “Sometimes”, 3 “Usually”, and 4 “Always”. | |
Secondary | Maternal health related quality of life | Maternal depression (postnatal depression) |
Definition | Continuous outcome ranging from zero (dead) to one (full health). | Dichotomous outcome based on the sum score: “No” sum score < 13 and “Yes” sum score > 12. |
Assessment | 5-level EQ-5D (EQ-5D-5 L). Each dimension within the questionnaire has 5 levels: 1 “no problems”, 2 “slight problems”, 3 “moderate problems”, 4 “severe problems”, and 5 “extreme problems”. Resulting in health profiles ranging from “11,111” through “55,555”. Continuous score calculated with the obtained profiles of the questionnaire with the validated EQ-5D-5 L calculator. | Edinburgh Postnatal Depression Scale (EPDS). Ten item scale. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. Range 0–30. |
Maternal perceived health | Maternal health care utilization | |
Definition | Continuous outcome ranging from zero (the worst health possible) to 100 (the best health possible). | Categorical outcome: “No additional care”, “One visit to the A and E department, GP, or GP out-of-hours service”, “Multiple visits”, and “Admission in a hospital” |
Assessment | EuroQol-visual analogue scales (EQ-VAS) represented by a 20 cm vertical scale. | Q1: Since your baby was born, have you had any symptoms for which you have been to the accident and emergency (A and E) department, GP or out-of-hours GP service? |
Q2: Have you been admitted to hospital since your baby was born? | ||
Neonatal health care utilization | ||
Definition | Categorical outcome ranging from: “No additional care”, “One visit to the A and E department, GP, or GP out-of-hours service”, “Multiple visits”, and “Admission in a hospital” | |
Assessment | Q1: Have you been to the accident and emergency (A and E) department, GP or out-of-hours GP service for your baby since he or she was born? | |
Q2: Has your baby been admitted to hospital since he or she was born? | ||
Maternal cigarette use | Maternal cigarette use | |
Definition | Dichotomous outcome (no/yes): “Yes” defined as any usage | Dichotomous outcome (no/yes): “Yes” defined as any usage |
Assessment | Q: Do you smoke? | Q: Do you smoke? |
Maternal alcohol use | Maternal alcohol use | |
Definition | Dichotomous outcome (no/yes): “Yes” defined as any usage | Dichotomous outcome (no/yes): “Yes” defined as any usage |
Assessment | Q: Do you drink alcohol? | Q: Do you drink alcohol? |
Maternal drugs use | Maternal drugs use | |
Definition | Dichotomous outcome (no/yes): “Yes” defined as any usage | Dichotomous outcome (no/yes): “Yes” defined as any usage |
Assessment | Q: Do you use drugs? Marijuana, hash and weed are drugs too. | Q: Do you use drugs? Marijuana, hash and weed are drugs too. |