Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2016
• Main ID: NCT02185625
• Date of registration: 01/07/2014
• Prospective Registration: Yes
• Primary sponsor: University of Aarhus
• Public title: Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana
• Scientific title: Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial
• Date of first enrolment: July 2014
• Target sample size: 3773
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02185625
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Ghana

Contacts

• Name: Christina MB Nielsen, BSc, MPH
• Affiliation: Department of Public Health, Aarhus University, Denmark

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Delivery, Obstetric

Postpartum Hemorrhage

Infant Mortality

Midwifery

Stillbirth

Intervention(s)

Device: Safe Delivery smartphone application

Primary Outcome(s)

Postpartum Hemorrhage. [Time Frame: Measurements 2 hours after delivery.]

Secondary Outcome(s)

Blood loss [Time Frame: Measurements 2 hours after delivery.]

Fresh stillbirth [Time Frame: At delivery.]

Key feature questionnaire (KFQ). [Time Frame: At baseline and 2 months after randomization.]

Objective structured assessment of technical skill (OSATS). [Time Frame: At baseline and 2 months after randomization.]

Neonatal mortality 7 days postpartum. [Time Frame: Within 7 days postpartum.]

Secondary ID(s)

AU201407

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lundbeck Foundation

Aase and Ejnar Danielsens Foundation

Augustinus Fonden

Edith and Godtfred Kirk Christiansen Foundation

University of Copenhagen

University of Ghana

Maternity Foundation