Maternal mortality and major morbidity from the three leading causes of maternal death worldwide: obstetric haemorrhage, sepsis and pre-eclampsia Pregnancy and Childbirth
Conditions
Interventions
This is a two-phased multicentre stepped wedge cluster randomised controlled trial of the introduction of the CRADLE package (Vital Signs device and training package) to maternity care settings in eig
Sponsors
Kings College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All pregnant/postpartum women living in Trial Area catchment areas* within the trial time frame 2. Women identified as pregnant or within the 6 weeks post-partum period, presenting for antenatal, intrapartum or postpartum care *Catchment areas will be defined by local investigators, and include all possible outreach facilities that result in women being assessed and referred to a defined central facility/ies, prior to randomisation and remain constant throughout the study period.
Exclusion criteria
Exclusion criteria: There will be no exclusion criteria, including age of women, 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 pregnancy. Data are to be collected at a cluster level rather than at an individual level.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures as of 01/04/2016 (Added 09/12/2016): The primary outcome is the rate of a composite of maternal mortality or major morbidity (one of maternal death, eclampsia or emergency hysterectomy with no double counting) per 10,000 deliveries. We will report the effect of the intervention on the primary endpoint, on each of the three components, and on the secondary endpoints specified. Results will be reported firstly as odds ratios, with risk ratios as a secondary comparison if the appropriate models converge. The components of the primary outcome are defined as: 1. Maternal death is defined as death during pregnancy or within 42 days of delivery (or last contact day if contact not maintained to 42 days). 2. Eclampsia is defined as occurrence of generalised convulsions or coma with increased BP during pregnancy, labour or within 42 days of delivery in the absence of epilepsy or another condition predisposing to convulsions 3. Emergency Hysterectomy is defined as surgical removal of all or part of the uterus Primary outcome measures as of 29/02/2016: 1. Maternal death, defined as death during pregnancy or within 42 days of delivery (or last contact day if contact not maintained to 42 days) 2. Eclampsia, defined as occurrence of generalised convulsions or coma with increased blood pressure during pregnancy, labour or within 42 days of delivery in the absence of epilepsy or another condition predisposing to convulsions 3. Emergency Hysterectomy, defined as surgical removal of all or part of the uterus Following the completion of the three month pilot phase from November 2015 to February 2016 there have been minor prospective amendments to the protocol prior to the start of the main trial in March 2016. Given the variable access to intensive care beds and low prevalence of stroke observed across our trial site | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 29/02/2016: Maternal Secondary outcome measures: 1. Intensive Care Unit admission, defined as any admission to a specific intensive care unit or an equivalent highest-level care environment within the trial area (or referral to the highest level care facility outside of the area) in areas where Intensive Care Unit does not exist 2. Stroke, defined as hemiparesis and/or blindness developed during pregnancy or in the 42 days postpartum lasting greater than 48 hours 3. Cause of intensive care admission 4. Cause of maternal death 5. Cause of emergency hysterectomy 5. Place of eclamptic fit 6. Place of maternal death These additional secondary outcome measures have been added following the pilot experience in an effort to determine the potential benefit of the device on these outcomes. Neonatal Secondary outcome measures We recognise that the CRADLE intervention may reduce neonatal mortality and morbidity, but have not been chosen to evaluate these as primary outcomes, as the intervention is designed specifically to identify maternal health complications. Many of these occur postpartum and will not directly influence perinatal outcomes. Acquisition of detailed perinatal data within LIC settings would be a substantial additional cost. However, we will collect secondary outcomes including: 1. Number of stillbirths 2. Number of neonatal deaths Original secondary outcome measures: We recognise that the CRADLE intervention may reduce neonatal mortality and morbidity, but have not been chosen to evaluate these as primary outcomes, as the intervention is designed specifically to identify maternal health complications. Many of these occur postpartum and will not directly influence perinatal outcomes. Acquisi | — |
Countries
Ethiopia, Haiti, India, Malawi, Sierra Leone, Uganda, Zambia, Zimbabwe
Contacts
Public ContactAndrew Shennan
Outcome results
None listed