CRADLE 5: Evaluating the national scale-up of the CRADLE vital signs alert device in Sierra Leone. Helping pregnant women get to the right place at the right time.

Current primary outcome measures as of 09/06/2023:
The primary outcome is the rate of a composite of maternal (per 10,000 deliveries) and neonatal (per 1000 deliveries) mortality or major maternal morbidity (with no double counting) occurring during pregnancy, labour or within 42 days of delivery including at least one of:
1. Maternal death (all-cause mortality) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
2. Stillbirth (born without signs of life at or after 28 weeks of gestation) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
3. Eclampsia (occurrence of generalised convulsions with increased blood pressure in the absence of epilepsy or another condition predisposing to convulsions) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
4. Emergency hysterectomy (surgical removal of all or part of the uterus) - measured using routinely collected data at baseline and monthly throughout the 12-month trial




Previous primary outcome measures:
The primary outcome is the rate of a composite of maternal (per 10,000 deliveries) and neonatal (per 1000 deliveries) mortality or major maternal morbidity (with no double counting) occurring during pregnancy, labour or within 42 days of delivery including at least one of:
1. Maternal death (all-cause mortality) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
2. Stillbirth (born without signs of life at or after 24 weeks of gestation) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
3. Eclampsia (occurrence of generalised convulsions with increased blood pressure in the absence of epilepsy or another condition predisposing to convulsions) - measured using routinely collected data at baseline and monthly throughout the 12-month trial
4. Emergency hysterectomy (surgical removal of all or part of the uterus) - measured using routinely collected data at baseline and monthly throughout the 12-month trial

1. Cause and place of maternal death - measured using routinely collected data at baseline and monthly throughout the trial
2. Number and cause of fresh and macerated stillbirths - measured using routinely collected data at baseline and monthly throughout the trial
3. Number and cause of early and late neonatal deaths - measured using routinely collected data at baseline and monthly throughout the trial
4. Place of eclamptic fit - measured using routinely collected data at baseline and monthly throughout the trial
5. Cause of emergency hysterectomy - measured using routinely collected data at baseline and monthly throughout the trial

Routinely collected markers of poor maternal and neonatal outcomes will also be collected from the District Health Information Software 2 (DHIS2) and the National Emergency Medical Service (NEMS) routine database as additional secondary outcomes for each district:
6. Number of obstetric complications related to pregnancy-induced hypertension - measured from routinely collected data from DHIS2 at baseline and monthly throughout the trial
7. Number of obstetric complications related to haemorrhage - measured from routinely collected data from DHIS2 at baseline and monthly throughout the trial
8. Number of obstetric complications related to pregnancy-related infection - measured from routinely collected data from DHIS2 at baseline and monthly throughout the trial
9. Number of obstetric complications related to anaemia - measured from routinely collected data from DHIS2 at baseline and monthly throughout the trial
10. Total number of maternity referrals - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial
11. Number of NEMS maternity referrals related to:
11.1. Hypertension - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial
11.2. Eclampsia - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial
11.3. Bleeding in pregnancy - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial
11.4. Pregnancy-related infection - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial
12. Number of NEMS maternity referrals with blood transfusion requested - measured from routinely collected data from the National Emergency Medical Service (NEMs) at baseline and monthly throughout the trial

Process and implementation outcomes measures include:
13.1. Fidelity/intervention implemented as intended i.e. number of facilities receiving CRADLE devices, number and proportion of healthcare staff trained in CRADLE, number and proportion of blood pressures taken and documented as per CRADLE training, fidelity of CRADLE training. Measured using routinely collected data, reporting forms and direct observations at baseline and monthly throughout the trial
13.2. Adoption/engagement and uptake of CRADLE i.e. timeliness and appropriateness of referrals before and after use of CRADLE, number of proportion of timely and accurate escalation of care when compared to before the introduction of CRADLE, measured using routinely collected data, direct observations, interviews, and focus groups monthly, at baseline, 6, 9-12 months
13.3. Acceptability/satisfaction with the CRADLE intervention among healthcare staff and women and local stakeholders, measured using routinely collected data, interviews and focus groups at baseline, 3, 6, 9-12 months
13.4 Womens' experiences by exploring their views and perspectives on the CRADLE intervention, referral, maternity care and exploring potential mechanisms of change, measured using interviews and focus groups at baseline, 3, 6, 9-12 months.

Baseline and monthly thereafter contextual measures across all districts using routinely collected DHIS2 data will include:
1.1. Number of deliveries completed by: doctor, midwife, SACHO (surgical assistant community health officers), SECHN midwife (state enrolled community health nurse midwife)
1.2. Number of deliveries completed by: CHO (community health officer), CHA (community health assistant), SECHN (state enrolled community health nurse), MCH Aide (maternal and child health aide)
1.3. Number of deliveries completed by: TBAs (traditional birth attendants) and others
2.1. Number of normal vaginal deliveries
2.2. Number of assisted vaginal deliveries
2.3. Number of caesarean sections
3.1. Number of women who had antenatal care 1st visit
3.2. Number of women who had antenatal care 1st visit under 12 weeks
3.3. Number of women who had antenatal care 4th visit (booked)
3.4. Number of women who had antenatal 8th visit (booked):
4.1. Stockout of magnesium sulphate (MgSO4)
4.2. Stockout of ampicillin
4.3. Stockout of gentamycin
4.4. Stockout of metronidazole
4.5. Stockout of oxytocin
4.6. Stockout of misoprostol