Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safe Delivery Smartphone Application | Experimental | 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 safe delivery smartphone application will be introduced to health workers in the intervention clusters. |
|
| Control | No Intervention | Health workers in the control clusters will not have access to the Safe Delivery App |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe Delivery Smartphone Application | Other | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 clinical performance in management of neonatal resuscitation | 0, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality stratified according to gestational age and birth weight | Participants will be followed from delivery until 7 days postpartum | |
| Use of the Safe Delivery application (when, how much and by whom) | Participants will be followed during the 12 months trial period |
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen | København V | 1658 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328731 | Derived | Christiansen AH, Sorensen BL, Boas IM, Bedesa T, Fekede W, Nielsen HS, Lund S. The impact of the Safe Delivery Application on knowledge and skills managing postpartum haemorrhage in a low resource setting: a cluster randomized controlled trial in West Wollega region, Ethiopia. Reprod Health. 2023 Jun 16;20(1):91. doi: 10.1186/s12978-023-01635-7. | |
| 27322089 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D063130 | Maternal Death |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Process indicators of services provided | Participants will be followed from delivery until 7 days postpartum |
| Lund S, Boas IM, Bedesa T, Fekede W, Nielsen HS, Sorensen BL. Association Between the Safe Delivery App and Quality of Care and Perinatal Survival in Ethiopia: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):765-71. doi: 10.1001/jamapediatrics.2016.0687. |
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |