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Completed

NCT Number: NCT02185625

Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

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.

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Key information

Conditions

Postpartum Hemorrhage Death Delivery, Obstetric Female Urogenital Diseases and Pregnancy Complications Fetal Death Hemorrhage Infant Death Infant Mortality Midwifery Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Stillbirth Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Achimota Hospital, Accra, Ghana

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safe Delivery smartphone application

Device

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.

Primary outcomes

  1. Postpartum Hemorrhage.

    Time frame: 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 outcomes

  1. Blood loss

    Time frame: Measurements 2 hours after delivery.

    Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.

  2. Key feature questionnaire (KFQ).

    Time frame: 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.

  3. Objective structured assessment of technical skill (OSATS).

    Time frame: 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.

  4. Fresh stillbirth

    Time frame: 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.

  5. Neonatal mortality 7 days postpartum.

    Time frame: Within 7 days postpartum.

    A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aase and Ejnar Danielsens Foundation
  • Augustinus Fonden
  • Edith and Godtfred Kirk Christiansen Foundation
  • Lundbeck Foundation
  • Maternity Foundation
  • University of Copenhagen
  • University of Ghana

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2014
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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