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Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Infant Mortality
Delivery, Obstetric
Stillbirth
Postpartum Hemorrhage
Midwifery

Treatments

Device: Safe Delivery smartphone application

Study type

Interventional

Funder types

Other

Identifiers

NCT02185625
AU201407 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

3,773 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,773 participants in 2 patient groups

Safe Delivery smartphone application
Experimental group
Treatment:
Device: Safe Delivery smartphone application
Control
No Intervention group

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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