Intervention Zambia Rural L&D Infection Study

NCT03809741 | Completed

• 1 other identifier: H-38261
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 5

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.

Conditions

Postpartum Infection; Neonatal Infection

Keywords

Infection prevention and control; Alcoholic hand rubs; Intrapartum care; Postpartum care; Infection Control Assessment Tool (ICAT); Rural Zambia

Outcome Measures

Primary Outcomes (1)

• Infection control practices assessed by Infection Control Assessment Tool (ICAT) score

  A survey including 98 questions detailing infection control practices in the L\&D. It includes questions on facility, Infection Prevention and Control (IPC) program, general IPC, hand hygiene, L\&D practices, and postpartum care practices. The scores from each question on the survey will be summed for the ICAT score for each health center. Maximum score is 140 points and minimum score is 0 points, with higher score indicating better infection control practices. Of the 98 questions, 34 questions are duplicated in an observation tool in order to corroborate the accuracy of survey information by direct observation. The observation tool includes topics on supplies in the L\&D and healthcare worker behaviors during childbirth. ICAT was developed by the Rational Pharmaceutical Management plus Infection Control Project team in 2009.

  12 weeks

Secondary Outcomes (5)

• Number of mothers with postpartum maternal infection from medical records

  12 weeks

• Number of newborns with postpartum neonatal infection from medical records

  12 weeks

• Rates of maternal hospital outcome categories from medical records

  12 weeks

• Rates of neonatal hospital outcomes from medical records

  12 weeks

• HCW attitudes towards infection control interventions from an anonymous survey

  12 weeks

Study Arms (1)

Preventing L&D Infections

EXPERIMENTAL

Low-cost bundled L\&D infection prevention interventions will be implemented, including education, visual reminders, feedback, and alcoholic hand rub supply. Infection control practices and child delivery outcomes will be assessed after implementation of these interventions.

Other: Bundled L&D Infection Prevention Interventions

Interventions

Bundled L&D Infection Prevention Interventions OTHER

The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks: Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6. Feedback: Monthly feedback sessions detailing IPC practices Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care. Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy

Preventing L&D Infections

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• Right to Care: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (5)

Mangunza Rural Health Facility

Choma, Southern Province, Zambia

Location

Masuku Mission Rural Health Facility

Choma, Southern Province, Zambia

Location

Mbabala Rural Health Facility

Choma, Southern Province, Zambia

Location

Mochipapa Rural Health Facility

Choma, Southern Province, Zambia

Location

Simakutu Rural Health Facility

Choma, Southern Province, Zambia

Location

Study Officials

• Davison Hamer, MD

  Boston University School of Public Health, Center for Global Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: April 11, 2019
• Primary Completion: August 16, 2019
• Study Completion: September 16, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5)