Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana (NCT02185625) | Clinical Trial Compass
CompletedNot Applicable
Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana
Ghana3,773 participantsStarted 2014-07
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.