CompletedNot Applicable

Low-dose High-frequency Training of Facility Health Care Providers in Mali

Mali79 participantsStarted 2019-07-15

Plain-language summary

This 3-arm cluster randomized trial (C-RCT) has the following objectives: Primary Aim To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality. Secondary Aims To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces: * Perinatal morbidity incidence * Post-partum Hemorrhage To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting increases ENC practices: * Early initiation and exclusive breast feeding * Thermal protection (prevention of hypothermia) * Clean cord care * Delayed bathing * Resuscitation-Initiation of breathing To determine if introduction of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting for CHWs decreases: * Delayed Identification of danger signs during pregnancy, labour and perinatal period * Delayed referral of complicated cases during pregnancy, labour and perinatal period To determine the cost effectiveness of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting

Who can participate

Sex

ALL

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: * All CSComs providing basic obstetric care with at least one health care provider trained in AMTSL, ENC and PNC with data collection/ utilization in Koulikoro, Kolokani, Banamba and Dioïla study clusters. * All community health workers reporting to an included CSCom. * All CSCom deliveries (both mother and newborn) in study clusters and live home births referred to a facility within the perinatal period. * Mother intending to maintain residence in study area for first week of newborn's life. Exclusion Criteria: * CSComs not providing basic obstetric care or not having trained maternal and neonatal health care providers in AMTSL, ENC and PNC and not collecting/utilizing data. * CHW's will be excluded if linked to an in-eligible CSCom or if they have not been trained in the standard MoH CHW training curriculum. * Failure to provide consent to enroll in study (intervention or control clusters).

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.

What they're measuring

Perinatal Mortality

Timeframe: First 7 days of life

Trial details

NCT IDNCT03656237

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-30

View on ClinicalTrials.gov More Perinatal Mortality trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.