Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

Postpartum Hemorrhage Clinical Trial

Official title:

Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185625
• Other study ID #: AU201407
• Secondary ID: AU201407
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: May 18, 2016
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3773
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery, Obstetric
• Infant Mortality
• Midwifery
• Postpartum Hemorrhage
• Stillbirth

Intervention

Device:
• Safe Delivery smartphone application
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.

Locations

Country	Name	City	State
Ghana	Achimota Hospital	Accra
Ghana	Ashaiman Polyclinic	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

Sponsors (8)

Lead Sponsor	Collaborator
University of Aarhus	Aase and Ejnar Danielsens Foundation, Augustinus Fonden, Edith and Godtfred Kirk Christiansen Foundation, Lundbeck Foundation, Maternity Foundation, University of Copenhagen, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Blood loss	Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.	Measurements 2 hours after delivery.	No
Secondary	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.	At baseline and 2 months after randomization.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No