Maternal Mortality, Perinatal Mortality
Conditions
Keywords
Maternal health, perinatal health, mHealth, smartphone, mobile phone, Ethiopia
Brief summary
The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.
Detailed description
Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters Design Cluster randomized controlled trial with health facilities as the unit of randomization Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities. Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills Study time Data collection expected from September 2013 to September 2014
Interventions
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication. The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.
Sponsors
Merck Sharp & Dohme LLC
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• Women in active labor
Exclusion criteria
• None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perinatal mortality (stillbirth and early neonatal death) | Participants will be followed from delivery until 7 days postpartum |
| Postpartum haemorrhage | Participants will be followed from delivery until two hours postpartum |
Secondary
| Measure | Time frame |
|---|---|
| Health workers clinical performance in management of neonatal resuscitation | 0, 6 and 12 months |
| Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta | 0, 6 and 12 months |
| Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage | 0, 6 and 12 months |
| Health workers knowledge of management of neonatal resuscitation | 0, 6 and 12 months |
Other
| Measure | Time frame |
|---|---|
| Use of the Safe Delivery application (when, how much and by whom) | Participants will be followed during the 12 months trial period |
| Mortality stratified according to gestational age and birth weight | Participants will be followed from delivery until 7 days postpartum |
| Process indicators of services provided | Participants will be followed from delivery until 7 days postpartum |
Countries
Denmark
Outcome results
None listed