Using Community Health Nurses and Workers for Home Visits to Pregnant Women to Improve Maternal and New Born Health in Ghana

NCT03907332 | Completed DMC

• 1 other identifier: GHS-ERC: 010/08/18
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Using Community Health Workers (CHWs) and Nurses (CHNs) to increase Skilled Attendant at Birth (SAB) and improve Maternal and Neonatal Health in Rural Ghana Background: SAB is a key strategy for improving maternal and new born health since most of the complications occurring at childbirth could be better managed when the delivery is supervised by a doctor, midwife or nurse. The effect of home visits to pregnant women by a CHW/CHN partnership on SAB is yet to be evaluated in a trial in Ghana. This trial will determine the effectiveness of a CHW/CHN home visit intervention to pregnant women on increasing SAB and improving birth outcomes for mothers and their neonates. Methods: Following ethical approval, we will train CHWs and CHNs to provide a package of health education and support for delivery during three home visits to each pregnant woman. This partnership will be evaluated through a cluster randomized controlled trial in 20 electoral areas in Ellembelle district of Ghana: 10 will be randomized to receive the CHW/CHN partnership intervention and 10 to the control arm (usual care), with a target recruitment of 46-50 women per cluster. The CHWs and CHNs will receive technical and financial support throughout the study. Data on SAB, maternal utilization of safe practices during pregnancy, breast feeding initiation, exclusive breastfeeding, immunization coverage for mother and new born, maternal deaths and neonatal death rates will be collected. The impact of the CHW/CHN intervention on these indicators will be reported. Keywords: Community Health Nurse, Community Health Worker, Maternal, New born, Supervised delivery, Post-natal, Effectiveness

Conditions

Pregnant Women; Home Visits

Keywords

Home visits; Community Health Nurse; Community Health Workers; Pregnant women; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Proportion of women having Skilled Attendant at Birth

  Numerator: Total number of deliveries with a Skilled Attendant at Birth Denominator: Total number of live births per arm

  12 months

Secondary Outcomes (6)

• - Proportion of pregnant women making the fourth antenatal visit

  12 months

• The breastfeeding initiation coverage within 1 hour after delivery among intervention and control arms

  12 months

• Proportion of women using Insecticide Treated Net (ITN) during pregnancy

  12 months

• Proportion of exclusively breastfed neonates at month 1

  12 months

• Maternal Mortality Rate

  12 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Study group 1 - Home visits by a team made up of a CHW and CHN in addition to all existing usual care practices (see below). Standardized educational Messages will be given during these scheduled home visits by the CHW-CHN including: * One visit during the second trimester of the pregnancy * Two visits during the third trimester of pregnancy

Other: Home visits

Control Arm

NO INTERVENTION

Study group 2 (Control) - Existing usual care practices. Usual Care includes at least four antenatal visits and care package which includes education on pregnancy, labour and delivery given at the health facility or at community settings to individuals and/or groups of pregnant women.

Interventions

Home visits OTHER

An experimental design, a cluster randomized controlled trial (RCT) will be used. A total of 20 clusters will be randomized with block randomization of electoral areas with a) resident staff midwives and b) resident Community Health Nurse midwifes. All women residing in an electoral area will receive the same intervention for practicality and to prevent contamination.

Also known as: Follow up home visits

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pregnant women age 15-49 years
• Presenting from 14 to 24 weeks of gestation
• The woman has completed 13 weeks of gestation
• The woman resides in the electoral area
• Resided continuously for three months prior to the start of the study

You may not qualify if:

• Pregnant women who have existing complications
• Woman requiring the care of a specialist
• Known previous Medical or Surgical history

Sponsors & Collaborators

• Ghana Health Services: lead
• University of Warwick: collaborator
• Ellembelle District Health Directorate Ghana: collaborator

Study Sites (1)

Western North Regional Health Directorate

Boadi, Western North, 00233, Ghana

Location

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Celia Brown, PHD

  University of Warwick

  STUDY DIRECTOR

• Paramjit Gill, MD. PHD

  University of Warwick

  STUDY DIRECTOR

• Abraham Hodgson, MD. PHD

  Ghana Health Services

  STUDY DIRECTOR

• Marion Okoh-Owusu, MD. MPH

  University of Warwick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent assessors will not know which women received the intervention or not. It is impossible to blind participants, persons conducting the visits or the researcher in this home visit intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Student

Model Details: One arm will receive the usual care and in addition, three home visits as the intervention compared to a control group, another arm, receiving only usual care

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)