Clinical trial NCT01945931: Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
Official title: Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Mortality
Perinatal Mortality
Keywords: Maternal health
perinatal health
mHealth
smartphone
mobile phone
Ethiopia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-09-19
Enrollment: 3601
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None

Primary outcomes:
measure: Perinatal mortality (stillbirth and early neonatal death)
timeFrame: Participants will be followed from delivery until 7 days postpartum
measure: Postpartum haemorrhage
timeFrame: Participants will be followed from delivery until two hours postpartum
Secondary outcomes:
measure: Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
timeFrame: 0, 6 and 12 months
measure: Health workers clinical performance in management of neonatal resuscitation
timeFrame: 0, 6 and 12 months
measure: Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
timeFrame: 0, 6 and 12 months
measure: Health workers knowledge of management of neonatal resuscitation
timeFrame: 0, 6 and 12 months
Other outcomes:
measure: Mortality stratified according to gestational age and birth weight
timeFrame: Participants will be followed from delivery until 7 days postpartum
measure: Use of the Safe Delivery application (when, how much and by whom)
timeFrame: Participants will be followed during the 12 months trial period
measure: Process indicators of services provided
timeFrame: Participants will be followed from delivery until 7 days postpartum
Locations:
city: København V
country: Denmark
facility: University of Copenhagen
Study officials:
References:
citation: 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.