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| ID | Type | Description | Link |
|---|---|---|---|
| AU201407 | Other Identifier | Aarhus University, Department of Public Health |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| University of Ghana | OTHER |
| Maternity Foundation | UNKNOWN |
| Augustinus Fonden |
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The purpose of this study is to determine whether use of the Safe Delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery application can increase midwives' knowledge and skills in managing childbirth.
Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe Delivery application (intervention), or to no intervention (control). In the intervention hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be enrolled at delivery and followed until 7 days postpartum. Data collection will begin July 2014 and is expected to be finished by October 2014.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safe Delivery smartphone application | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe Delivery smartphone application | Device | The intervention is the use of a smartphone application called Safe Delivery, designed by University of Copenhagen, Denmark and Maternity Foundation Denmark. The application contains animated videos aimed to train midwives in the prevention and management of postpartum hemorrhage and the treatment of neonatal resuscitation. The instructions in the videos are based on WHO recommendations, and the application is designed to be an on-going tool for midwives, so that they can drill themselves in the emergencies of postpartum hemorrhage and neonatal resuscitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum Hemorrhage. | Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum. | Measurements 2 hours after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum. | Measurements 2 hours after delivery. |
| Key feature questionnaire (KFQ). | The KFQ questionnaire measures midwives' knowledge in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the KFQ tool. |
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Inclusion criteria for Hospitals:
Inclusion criteria for midwives:
Inclusion criteria for women in labor:
The women in labor and their newborn children will be the primary observational units.
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| Name | Affiliation | Role |
|---|---|---|
| Christina MB Nielsen, BSc, MPH | Department of Public Health, Aarhus University, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achimota Hospital | Accra | Ghana | ||||
| Ashaiman Polyclinic |
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| OTHER |
| Lundbeck Foundation | OTHER |
| Edith and Godtfred Kirk Christiansen Foundation | UNKNOWN |
| Aase and Ejnar Danielsens Foundation | OTHER |
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|
| At baseline and 2 months after randomization. |
| Objective structured assessment of technical skill (OSATS). | The OSATS tool measures midwives' skills in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the OSATS tool. | At baseline and 2 months after randomization. |
| Fresh stillbirth | Delivery of a fetus with a birth weight above 1,000 g birth weight who at birth has no signs of life (breathing, crying or movement) with intact skin. | At delivery. |
| Neonatal mortality 7 days postpartum. | A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum. | Within 7 days postpartum. |
| Accra |
| Ghana |
| Ga South Municipal Hospital | Accra | Ghana |
| Ga West Municipal Hospital | Accra | Ghana |
| Keneshi Polyclinic | Accra | Ghana |
| La General Hospital | Accra | Ghana |
| Lekma Hospital | Accra | Ghana |
| Maamobi General Hospital | Accra | Ghana |
| Madina Polyclinic | Accra | Ghana |
| Mamprobi Polyclinic | Accra | Ghana |
| Ridge Hospital | Accra | Ghana |
| Shai Osu Doku District Hospital | Accra | Ghana |
| Tema General Hospital | Accra | Ghana |
| Tema Polyclinic | Accra | Ghana |
| Usher Poly (James Town Maternity Home) | Accra | Ghana |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D050497 | Stillbirth |
| D066088 | Infant Death |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |
| D003643 | Death |
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