Clinical trial NCT02185625: Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana
Official title: Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Delivery, Obstetric
Stillbirth
Infant Mortality
Midwifery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Ghana
name: Maternity Foundation
name: Augustinus Fonden
name: Lundbeck Foundation
name: Edith and Godtfred Kirk Christiansen Foundation
name: Aase and Ejnar Danielsens Foundation
First posted: 2014-07-09
Enrollment: 3773
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria for Hospitals:

* Located in the region of Greater Accra.
* The hospital should have at least 10 midwives employed.
* The patient flow for each midwife should be at least 10 deliveries per month.
* The annual average number of deliveries should be at least 1,200.

Inclusion criteria for midwives:

* Should have no leave or vacation from June 17th to September 17th 2014.
* Should have a full time employment at the delivery ward (conducting deliveries 100% of the work time).
* Should be willing and available to participate in an information meeting at the hospital where the balloting among eligible midwives will take place.
* Should give an informed consent to participate in the study.
* Should be willing and available to participate in a workshop July 14th 2014 (this is the day of randomization, and intervention midwives will receive smartphone training).
* Should be willing and available to participate in a workshop September 17th 2014 (to complete an end of study questionnaire, the key feature questionnaire, and control midwives will receive smartphones).
* Should be proficient in English to understand the spoken instructions in the animated videos.

Inclusion criteria for women in labor:

* Should be in active labor.
* Should give informed consent to participate in the study.
* Should give birth vaginally.

The women in labor and their newborn children will be the primary observational units.

Primary outcomes:
measure: Postpartum Hemorrhage.
timeFrame: Measurements 2 hours after delivery.
Secondary outcomes:
measure: Blood loss
timeFrame: Measurements 2 hours after delivery.
measure: Key feature questionnaire (KFQ).
timeFrame: At baseline and 2 months after randomization.
measure: Objective structured assessment of technical skill (OSATS).
timeFrame: At baseline and 2 months after randomization.
measure: Fresh stillbirth
timeFrame: At delivery.
measure: Neonatal mortality 7 days postpartum.
timeFrame: Within 7 days postpartum.
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Achimota Hospital
city: Accra
country: Ghana
facility: Ashaiman Polyclinic
city: Accra
country: Ghana
facility: Ga South Municipal Hospital
city: Accra
country: Ghana
facility: Ga West Municipal Hospital
city: Accra
country: Ghana
facility: Keneshi Polyclinic
city: Accra
country: Ghana
facility: La General Hospital
city: Accra
country: Ghana
facility: Lekma Hospital
city: Accra
country: Ghana
facility: Maamobi General Hospital
city: Accra
country: Ghana
facility: Madina Polyclinic
city: Accra
country: Ghana
facility: Mamprobi Polyclinic
city: Accra
country: Ghana
facility: Ridge Hospital
city: Accra
country: Ghana
facility: Shai Osu Doku District Hospital
city: Accra
country: Ghana
facility: Tema General Hospital
city: Accra
country: Ghana
facility: Tema Polyclinic
city: Accra
country: Ghana
facility: Usher Poly (James Town Maternity Home)
Study officials:
affiliation: Department of Public Health, Aarhus University, Denmark
name: Christina MB Nielsen, BSc, MPH
role: PRINCIPAL_INVESTIGATOR
References: