Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

Not Applicable

Completed

• Conditions: Stillbirth; Midwifery; Postpartum Hemorrhage; Infant Mortality; Delivery, Obstetric
• Interventions: Device: Safe Delivery smartphone application

• Registration Number: NCT02185625
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3773

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safe Delivery smartphone application	Safe Delivery smartphone application	-

Primary Outcome Measures

Name	Time	Method
Postpartum Hemorrhage.	Measurements 2 hours after delivery.	Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.

Secondary Outcome Measures

Name	Time	Method
Key feature questionnaire (KFQ).	At baseline and 2 months after randomization.	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.
Objective structured assessment of technical skill (OSATS).	At baseline and 2 months after randomization.	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.
Neonatal mortality 7 days postpartum.	Within 7 days postpartum.	A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.
Blood loss	Measurements 2 hours after delivery.	Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
Fresh stillbirth	At delivery.	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.

Trial Locations

Locations (15)

Maamobi General Hospital; 🇬🇭 Accra, Ghana

Shai Osu Doku District Hospital; 🇬🇭 Accra, Ghana

Achimota Hospital; 🇬🇭 Accra, Ghana

Ga South Municipal Hospital; 🇬🇭 Accra, Ghana

Ashaiman Polyclinic; 🇬🇭 Accra, Ghana

Keneshi Polyclinic; 🇬🇭 Accra, Ghana

La General Hospital; 🇬🇭 Accra, Ghana

Lekma Hospital; 🇬🇭 Accra, Ghana

Madina Polyclinic; 🇬🇭 Accra, Ghana

Mamprobi Polyclinic; 🇬🇭 Accra, Ghana

Ridge Hospital; 🇬🇭 Accra, Ghana

Ga West Municipal Hospital; 🇬🇭 Accra, Ghana

Tema Polyclinic; 🇬🇭 Accra, Ghana

Usher Poly (James Town Maternity Home); 🇬🇭 Accra, Ghana

Tema General Hospital; 🇬🇭 Accra, Ghana