Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01945931
Study type Interventional
Source University of Copenhagen
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date January 2015

See also
  Status Clinical Trial Phase
Completed NCT01681017 - Global Network Implementation of Helping Babies Breathe (HBB) N/A
Completed NCT03590483 - Outcomes in Spontaneous and ART Twin Pregnancies
Completed NCT00133744 - Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality Phase 3
Completed NCT01115478 - Malaria in Pregnancy: Nutrition and Immunologic Effects N/A
Completed NCT00640055 - Verbal Autopsy to Assess Early Neonatal Death and Stillbirth Phase 4
Terminated NCT00536003 - Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor Phase 3
Completed NCT03656237 - Low-dose High-frequency Training of Facility Health Care Providers in Mali N/A
Completed NCT00860470 - Antenatal Micronutrient Supplementation and Infant Survival Phase 3
Completed NCT02189265 - Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands N/A
Completed NCT04663620 - Saving Babies Lives N/A
Recruiting NCT03108404 - Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation N/A
Not yet recruiting NCT03398551 - Machine Learning From Fetal Flow Waveforms to Predict Adverse Perinatal Outcomes N/A