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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 (CORN)

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ClinicalTrials.gov Identifier: NCT02501252
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Ethiopian Public Health Institute
Ministry of Health, Ethiopia
Information provided by (Responsible Party):
Dilla University

Brief 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


Condition or disease Intervention/treatment Phase
Maternal Care Patterns Procedure: trained midwives and nurses working in the community to provide skilled SBA services Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2670 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: CORN were assigned into three arms namely: HP, HC and control arms
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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 Randomized Controlled Community Trial in Gedeo Zone, SNNPR
Study Start Date : November 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: CORN Based at health post
Trained CORN based at health post will provide SBA and other RH services on demand at health post or household levels on an outreach bases.
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.

Active Comparator: CORN Based at health center
Trained CORN based at health center, but working in the community in an outreach basis will provide SBA and other RH services
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.

No Intervention: Control
will be composed of a randomly selected comparable controls clusters. Control clusters (arm) will be similar with the other two arms (groups) except for the intervention.



Primary Outcome Measures :
  1. Percentage increase in skilled Delivery [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  2. Percent of stakeholders accepting CORN intervention [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line qualitative survey).


Secondary Outcome Measures :
  1. Percent of FP (long term)services uptake [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  2. Percent of FANC services uptake [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  3. Percent of PNC services uptake [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  4. Percent of PMTCT uptake [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  5. Neonatal morbidity [ Time Frame: 9 month ]
    This will be measured twice (baseline and end line survey using interviewer administered questionnaire and from health facility records!)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women who are willing
  • Permanent residents

Exclusion Criteria:

  • Pregnant mother not from the selected Kebeles.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501252


Locations
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Ethiopia
Dilla University, College of Medicine and Health Sciences
Addis Ababa, Ethiopia, 419
Sponsors and Collaborators
Dilla University
Ethiopian Public Health Institute
Ministry of Health, Ethiopia
Investigators
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Principal Investigator: Taddese Alemu, PhD Dilla University

Publications:
WHO, UNICEF, UNFPA and The World Bank, 2. Trends in maternal mortality: 1990 to 2010; Geneva, Switzerland, 2012
Ahmed Abdella: Maternal Mortality Trend in Ethiopia, Ethiop. J. Health Dev. 2010;24 Special Issue 1:115-122
Mesganaw F, Olwit G, Shamebo D. Determinants of ANC attendance and preference to place of delivery in Gulele District. Ethiop J Health Dev. 1992;6(2):17-22
Mekonnen Yared, Mekonnen Asnaketch. Utilization of Maternal Health Care Services in Ethiopia. Calverton, Maryland, USA: ORC Macro; 2002
Mesfin M, Farrow J. Determinants of ANC utilization in Arsi Zone, Central Ethiopia. Ethiop J Health Dev. 1996;10(3):171-178
Marge Koblinsky et.al: Responding to the maternal health care challenge: The Ethiopian Health Extension Program, Ethiop. Health Dev. 2010;24 Special Issue 1:105-109

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dilla University
ClinicalTrials.gov Identifier: NCT02501252     History of Changes
Other Study ID Numbers: RPC674
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Keywords provided by Dilla University:
Community
Skilled birth attendance
Rural
Ethiopia