Table 4 List of outcomes and definition of outcome indicators
Outcome | Definition | Type | Indicators | Details |
|---|---|---|---|---|
Primary outcome | ||||
 Complete CoC (maternal behaviour-based) | Time-dependent composite outcome. Complete CoC is the minimum number of ANC visits + facility-based delivery + PNC for mother and newborn + child vaccinations at two time points—at birth and at 2~3 months. Includes women who attended ANC and other MCNH services only. Complete CoC = 1 when all indicators = 1 | Binary | First ANC timing | Timeline divided into ≤ 20, 21~30, 31~37 and 38 weeks~ ga |
No. of ANC services | < 4 = 0, ≥ 4 = 1 (≤ 20 weeks); < 3 = 0, ≥ 3 = 1 (21–30 weeks); < 2 = 0, ≥ 2 = 1 (31~37 weeks); < 1 = 0, ≥ 1 = 1 (38 weeks) | |||
Facility delivery | No = 0; yes = 1 | |||
PNC_mother | No HBR record = 0; HBR record = 1 | |||
PNC_child | No HBR record = 0; HBR record = 1 | |||
Vaccinations at birth and at 2 months infant age | < 2 vacc clinic visits = 0; 2 vacc visits = 1 | |||
Secondary outcomes | ||||
 Rate of MNCH service utilisation | Total no. of actual MCH service used per person per arm compared with an expected minimum number of service utilisation. Estimate means for each arm | Continuous | No. of ANC services | No. of women with a minimum number of ANC in each arm |
Facility delivery | No of women with facility delivery in each arm | |||
PNC_mother | No. of women with mother PNC record in each arm | |||
PNC_child | No. of women with child PNC record in each arm | |||
Vaccination | No. of women with child vacc record in each arm | |||
 Complete CoC (service-based) | Time-dependent composite outcome. Composite outcome including ≥ 4 ANC visits + facility-based delivery + PNC of mother and newborn + complete child immunisation up to 2~3 months. Complete CoC = 1 when all indicators = 1 | Binary | First ANC timing | Timeline divided into ≤ 20, 21~30, 31~37 and 38 weeks~ ga |
No. of ANC services | < 4 = 0, ≥ 4 = 1 (≤ 20 weeks); < 3 = 0, ≥ 3 = 1 (21–30 weeks); < 2 = 0, ≥ 2 = 1 (31~37 weeks); < 1 = 0, ≥ 1 = 1 (38 weeks) | |||
Facility delivery | No = 0; yes = 1 | |||
PNC_mother | No HBR record = 0; HBR record = 1 | |||
PNC_child | No HBR record = 0; HBR record = 1 | |||
Vaccination | < 7 records = 0; 7 records = 1 | |||
 Neonatal mortality | No. of deaths within the first 28 days of life compared to the total number of deliveries in each study arm. NM = 1 when all indicators = 1 | Binary | Live birth | No = 0; yes = 1 |
Infant death | No = 0; yes = 1 | |||
Date of death | Death within 28 days of birth = 1 | |||
ANC service utilisation | No. of women who receive ≥ 4 ANC visits in each arm regardless of the timing of first ANC. Adequate ANC = 1 if no. of ANC services = 1 | Binary | First ANC timing | 1st trimester, 2nd trimester, 3rd trimester |
Received ANC | No = 0; yes = 1 | |||
No. of ANC services | < 4 = 0; ≥ 4 = 1 | |||
No. of women who receive ≥ 8 ANC visits in each arm regardless of the timing of first ANC. Adequate ANC = 1 if no. of ANC services = 1 | Binary | First ANC timing | 1st trimester, 2nd trimester, 3rd trimester | |
Received ANC | No = 0; yes = 1 | |||
No. of ANC services | < 8 = 0; ≥ 8 = 1 | |||
 Facility-based delivery | No. of facility-based deliveries in each arm. | Binary | Facility delivery | No = 0; yes = 1 |
 Infant health check-up | Presence of at least one HBR entry from baby-well clinic attendance. | Binary | Record entry for any of current wgt, polio1, pentavalent, pneumo1 or rota1 | No HBR record = 0; HBR record (for any of current wgt, polio1, pentavalent, pneumo1 or rota1) = 1 |
 Maternal morbidity and pregnancy complication detection rate | No. of cases of specified disease conditions and pregnancy complications diagnosed by an HCP in each arm. Maternal morbidity = 1 if any indicator = 1 | Binary | High blood pressure | No HBR record = 0; HBR record = 1 |
Preeclampsia | No HBR record = 0; HBR record = 1 | |||
Miscarriage | No HBR record = 0; HBR record = 1 | |||
Stillbirth | No HBR record = 0; HBR record = 1 | |||
Vaginal bleeding | No HBR record = 0; HBR record = 1 | |||
Anaemia | No HBR record = 0; HBR record = 1 | |||
Malaria | No HBR record = 0; HBR record = 1 | |||
TB | No HBR record = 0; HBR record = 1 | |||
HIV | No HBR record = 0; HBR record = 1 | |||
Diabetes | No HBR record = 0; HBR record = 1 | |||
 Infant morbidity rate | Total no. of disease cases attended by an HCP. Infant morbidity = 1 if all indicators = 1 | Binary | Past month sickness | No = 0; yes = 1 |
Sought treatment | No = 0; yes = 1 | |||
Treatment from HP | No = 0; yes = 1 | |||
 Infant mortality | No of deaths of infants < 1 year old compared to the total number of deliveries in each study arm. IM = 1 when if both indicators = 1 | Binary | Livebirth | No = 0; yes = 1 |
Infant death | No = 0; yes = 1 | |||
 Maternal health behaviour | Prevalence of maternal health behaviour between arms with regard to tobacco use, alcohol use, PMTCT, malaria prevention, use of ITNs and family planning. Prevalence of each indicator will be compared between the intervention and control arms. | Binary | Current alcohol use | No = 0; yes = 1 |
Current tobacco use | No = 0; yes = 1 | |||
PMTCT | No = 0; yes = 1 | |||
Family planning use | No = 0; yes = 1 | |||
Knowledge change tobacco use | No = 0; yes = 1 | |||
Knowledge change alcohol use | No = 0; yes = 1 | |||
 Malaria prevention |  | Binary | ITN possession | No = 0; yes = 1 |
ITN use | No = 0; yes = 1 | |||
Malaria prophylaxis use | No = 0; yes = 1 | |||
 Maternal depression | No. of cases of maternal postnatal depressive symptoms in each arm. | Binary | EPDS | < 10 = 0; ≥ 10 = 1 |
 Infant feeding practices | Appropriate infant feeding practices including EIBF, EBF and absence of pre-lacteal feeding. Adequate if all indicators = 1 | Binary | EIBF | After 1 h = 0; within 1 h = 1 |
Pre-lacteal feeding | Yes = 0; no = 1 | |||
Current BF | No = 0; yes = 1 | |||
 Child vaccination | Composite outcome for the no. of complete fully vaccinated children at 3 months in each study arm. Vaccination = 1 if all indicators = 1 | Binary | Polio0 | No HBR record = 0; HBR record = 1 |
BCG | No HBR record = 0; HBR record = 1 | |||
Hepatitis B | N HBR record = 0; HBR record = 1 | |||
Polio1 | No HBR record = 0; HBR record = 1 | |||
Pentavalent | No HBR record = 0; HBR record = 1 | |||
Pneumo1 | No HBR record = 0; HBR record = 1 | |||
Rotavirus1 | No HBR record = 0; HBR record = 1 | |||