Effectiveness and Acceptability of Availing Skilled Birth Attendance (SBA) Services Through Community Reproductive Health Nurses (CORN) to a Household Level at Rural Communities of Ethiopia; A Cluster Community Trial in Gedeo Zone, SNNPR

NCT02501252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2670

Last updated 2019-02-08

No results posted yet for this study

Summary

Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and the majority of these deaths have been identified as being avoidable. A proxy indicator of Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal deaths. The Ethiopia health system has established a vast network of health infrastructure that extends to rural areas with the establishment of over 15,000 health posts and deployment of over 30,000 health extension workers throughout the country. Although these unprecedented situations made health services more accessible than ever, it is yet to be exploited for improving rural women's access to clean and safe delivery and postpartum care. Lack of usage of delivery care in the country is related not only to accessibility but also acceptability of the services. In fact, the vast majority of women with home deliveries saw institutional delivery as "unnecessary" and a "non-customary practice". Therefore, instituting an innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for example might be the best remedy, in this case.

Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural communities of Ethiopia.

Study design: Cluster Randomized Controlled Community Trial that will be conducted in four phases.

Study population: Study participants will be all pregnant women who will give birth at home and health facility (including health post) during the study period.

Intervention: The study will be conducted in four phases as discussed below. During the first (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will be conducted. In the second phase, formative and baseline assessment as well as training of CORNs will take place. In the third phase, which will be actual intervention phase, deployment of CORNs in their respective study site will be done and in the final phase, final evaluation and dissemination of study findings will be done. The intension behind deploying CORNs to the grassroots level is just to give a backup skilled delivery and other MNH services to poor rural mothers who have difficult of accessing modern health facilities for various reasons; it has no any intention to promote or encourage home deliveries or replace institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health facilities Main study parameters/endpoints: The main study end point is percentage of skilled birth attendance which is very low in local and national level. In addition secondary study parameters are percentage changes of maternal \& related services uptakes. These include focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child Transmission of HIV (PMTCT) and postnatal care.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden and risks associated with participation to the study is very minimal. To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of pregnancy this will be anonymous except for the CORNs keeping the principles of shared confidentiality in mind. Similarly all questionnaires or medical charts will be kept confidential. All CORNs will obtain intensive training on ethical principles that will help to minimize any physical and physiological discomfort associated with participation, the risks associated with the investigation treatment.

The study period and Budget: the study will be carried out in a total of 18 months which holds a period from the development of protocol to the terminal evaluation and submission of reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred eighty seven dollars and ninety five cents

Conditions

  • Maternal Care Patterns

Interventions

PROCEDURE

trained midwives and nurses working in the community to provide skilled SBA services

After the completion of all the necessary preparations, trained CORNs will be deployed for ten months in their respective study sites (arms) to provide the required RH services at home, community and health posts.

Sponsors & Collaborators

  • Ethiopian Public Health Institute

    collaborator OTHER_GOV
  • Ministry of Health, Ethiopia

    collaborator OTHER_GOV
  • Dilla University

    lead OTHER

Principal Investigators

  • Taddese Alemu, PhD · Dilla University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501252 on ClinicalTrials.gov