Reduction of maternal and perinatal morbidity and mortality from obstetric haemorrhage, sepsis and pre-eclampsia in pregnant or postpartum women in Sierra Leone Pregnancy and Childbirth
Conditions
Interventions
The researchers will undertake a implementation-effectiveness cluster randomised controlled trial in a stepped wedge design, rolling out the intervention and prospectively evaluating both the implemen
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All pregnant/postpartum women living in the Trial District within the trial timeframe accessing government maternity healthcare
Exclusion criteria
Exclusion criteria: No women will be excluded from this trial criteria, as, from an ethical and logistical standpoint, all pregnant women (including those below the age of 16 years) should have access to blood pressure measurement during the antenatal care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 colle | — |
Countries
Sierra Leone
Outcome results
None listed