Clinical trial NCT03809741: Intervention Zambia Rural L&D Infection Study
Official title: Prevention of Neonatal and Maternal Infection During Labor and Delivery in Rural Healthcare Sites in Zambia - Intervention Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Infection
Neonatal Infection
Keywords: Infection prevention and control
Alcoholic hand rubs
Intrapartum care
Postpartum care
Infection Control Assessment Tool (ICAT)
Rural Zambia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Right to Care
name: Fogarty International Center of the National Institute of Health
First posted: 2019-01-18
Enrollment: 37
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is the intervention phase of a study to investigate the impact of low-cost bundled interventions on improving the infection control practices in the labor and delivery units in rural healthcare settings in Zambia. A baseline observational phase of the health care providers' infection control procedures was done. In this intervention phase, low-cost bundle of interventions, including health care provider education, behavior feedback, visual and Short Message Service (SMS)/text message reminders, and provision of alcoholic hand rubs, will be implemented at 5 study sites. 12 weeks after the initiation of interventions, endline data will be collected. The data from endline after interventions will be compared with baseline data from observational phase to detect changes in infection control practices at each study site after the interventions.

Detailed description: The total duration of the intervention phase is estimated to be 4 months. During this time, the investigators will collaborate with the healthcare workers (HCWs) at each study site and the district pharmacist.

The study team will visit each site separately and administer the training modules on-site during the first month of the research until all of the modules have been completed for all of the Labor and Delivery (L\&D) staff, which usually consist of about 2-3 people. A quiz will be administered before and after the training session to assess change in knowledge after the training.

SMS reminders will be sent every weekday to promote best infection control practices in the L\&D. Posters will also be posted for visual reminders of best practices around the health center.

After the initial training, each health centers will be visited twice a month by a study team member to assess alcohol rubs (AHR) stock, gather feedback and comments, and evaluate postpartum maternal and neonatal infectious complications and hospital outcomes. Infection and outcome data will be shared with each site monthly. About 2 months after initial training, a refresher education and training course will be held at each study site. A quiz will be administered before and after the refresher course to assess knowledge.

The investigators will collaborate with the district pharmacy for production and distribution of AHR. The pharmacists will receive training on how to combine and mix the hand rub components per WHO guidelines, and test batches will be made prior to distribution to study sites to ensure familiarity of the pharmacy staff with its production. Quality control with an alcoholmeter will be performed with the alcohol ingredient and with the finished product, as per World Health Organization (WHO) recommendation. Afterwards, the head pharmacist will be consulted biweekly by study team member to document AHR production, budget, distribution, and any other issues.

Endline data collection will occur 12 weeks after initiation of intervention implementation. During data collection period, a study team member will meet with a L\&D floor administrator in a private setting at a time convenient to the administrator to go through the questionnaire portion of the ICAT together.

Eligible pregnant women will primarily be recruited and consented outside the facility in the waiting area where they congregate prior to admission for delivery. Women who are consented will be given a "consent card" in addition to a copy of the consent form. This card will state that they have previously consented to the study, and can then be presented once they are admitted for delivery. A member of the research team will accompany the primary care provider during their provision of care and patient contact during first, second, and third stages of labor to observe, assess and document infection control behaviors and practices by the providers, using the ICAT.

A retrospective review of the logbook will be done to assess for rates of postpartum maternal and neonatal infectious complication and outcomes for participants.

During the endline data collection, an anonymous, self-administered survey will be administered to the study site HCWs to assess the knowledge, attitudes and practices of the study site HCWs towards the implemented study interventions.

Eligibility criteria: Inclusion Criteria for observation:

* Women of age \> 15 in early first stage of labor (cervical dilation ≤ 6cm) at the study sites during the study period
* If woman is 15 to 17 must have a guardian present
* Planned vaginal delivery
* Any healthcare workers providing direct patient care to women delivering at the study sites during study period

Exclusion Criteria for observation:

* Any eligible woman who presents past the early first stage of labor (cervical dilation \> 6cm)
* Woman under 18 years old without a guardian present

Inclusion criteria for logbook review:

* Women who delivered their baby at the study sites during the study period
* Newborns who were born at the study sites during the study period

Primary outcomes:
measure: Infection control practices assessed by Infection Control Assessment Tool (ICAT) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of mothers with postpartum maternal infection from medical records
timeFrame: 12 weeks
measure: Number of newborns with postpartum neonatal infection from medical records
timeFrame: 12 weeks
measure: Rates of maternal hospital outcome categories from medical records
timeFrame: 12 weeks
measure: Rates of neonatal hospital outcomes from medical records
timeFrame: 12 weeks
measure: HCW attitudes towards infection control interventions from an anonymous survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Choma
country: Zambia
facility: Mangunza Rural Health Facility
state: Southern Province
city: Choma
country: Zambia
facility: Masuku Mission Rural Health Facility
state: Southern Province
city: Choma
country: Zambia
facility: Mbabala Rural Health Facility
state: Southern Province
city: Choma
country: Zambia
facility: Mochipapa Rural Health Facility
state: Southern Province
city: Choma
country: Zambia
facility: Simakutu Rural Health Facility
state: Southern Province
Study officials:
affiliation: Boston University School of Public Health, Center for Global Health
name: Davison Hamer, MD
role: STUDY_DIRECTOR
References: