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 | Completed

• 1 other identifier: RPC674
• Study Type: interventional
• Target: 2,670
• Locations: 1 country
• Sites: 1

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

Conditions

Maternal Care Patterns

Keywords

Community; Skilled birth attendance; Rural; Ethiopia

Outcome Measures

Primary Outcomes (2)

• Percentage increase in skilled Delivery

  This will be measured twice (baseline and end line survey using interviewer administered questionnaire).

  9 month

• Percent of stakeholders accepting CORN intervention

  This will be measured twice (baseline and end line qualitative survey).

  9 month

Secondary Outcomes (5)

• Percent of FP (long term)services uptake

  9 month

• Percent of FANC services uptake

  9 month

• Percent of PNC services uptake

  9 month

• Percent of PMTCT uptake

  9 month

• Neonatal morbidity

  9 month

Study Arms (3)

CORN Based at health post

EXPERIMENTAL

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

CORN Based at health center

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

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

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.

CORN Based at health center; CORN Based at health post

Eligibility Criteria

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

You may qualify if:

• Pregnant women who are willing
• Permanent residents

You may not qualify if:

• Pregnant mother not from the selected Kebeles.

Sponsors & Collaborators

• Dilla University: lead
• Ethiopian Public Health Institute: collaborator
• Ministry of Health, Ethiopia: collaborator

Study Sites (1)

Dilla University, College of Medicine and Health Sciences

Addis Ababa, 419, Ethiopia

Location

Related Publications (21)

• WHO, UNICEF, UNFPA and The World Bank, 2. Trends in maternal mortality: 1990 to 2010; Geneva, Switzerland, 2012

  BACKGROUND

• Ahmed Abdella: Maternal Mortality Trend in Ethiopia, Ethiop. J. Health Dev. 2010;24 Special Issue 1:115-122

  BACKGROUND

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  PMID: 1682600 BACKGROUND

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  BACKGROUND

• Adegoke AA, van den Broek N. Skilled birth attendance-lessons learnt. BJOG. 2009 Oct;116(Suppl 1):33-40. doi: 10.1111/j.1471-0528.2009.02336.x.

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• Medhanyie A, Spigt M, Kifle Y, Schaay N, Sanders D, Blanco R, GeertJan D, Berhane Y. The role of health extension workers in improving utilization of maternal health services in rural areas in Ethiopia: a cross sectional study. BMC Health Serv Res. 2012 Oct 8;12:352. doi: 10.1186/1472-6963-12-352.

  PMID: 23043288 BACKGROUND

• Medhanyie A, Spigt M, Dinant G, Blanco R. Knowledge and performance of the Ethiopian health extension workers on antenatal and delivery care: a cross-sectional study. Hum Resour Health. 2012 Nov 21;10:44. doi: 10.1186/1478-4491-10-44.

  PMID: 23171076 BACKGROUND

• Mekonnen Yared, Mekonnen Asnaketch. Utilization of Maternal Health Care Services in Ethiopia. Calverton, Maryland, USA: ORC Macro; 2002

  BACKGROUND

• Teferra AS, Alemu FM, Woldeyohannes SM. Institutional delivery service utilization and associated factors among mothers who gave birth in the last 12 months in Sekela District, north west of Ethiopia: a community-based cross sectional study. BMC Pregnancy Childbirth. 2012 Jul 31;12:74. doi: 10.1186/1471-2393-12-74.

  PMID: 22849421 BACKGROUND

• Girma M, Yaya Y, Gebrehanna E, Berhane Y, Lindtjorn B. Lifesaving emergency obstetric services are inadequate in south-west Ethiopia: a formidable challenge to reducing maternal mortality in Ethiopia. BMC Health Serv Res. 2013 Nov 4;13:459. doi: 10.1186/1472-6963-13-459.

  PMID: 24180672 BACKGROUND

• Mesfin M, Farrow J. Determinants of ANC utilization in Arsi Zone, Central Ethiopia. Ethiop J Health Dev. 1996;10(3):171-178

  BACKGROUND

• 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

  BACKGROUND

• Harvey SA, Blandon YC, McCaw-Binns A, Sandino I, Urbina L, Rodriguez C, Gomez I, Ayabaca P, Djibrina S; Nicaraguan Maternal and Neonatal Health Quality Improvement Group. Are skilled birth attendants really skilled? A measurement method, some disturbing results and a potential way forward. Bull World Health Organ. 2007 Oct;85(10):783-90. doi: 10.2471/blt.06.038455.

  PMID: 18038060 BACKGROUND

• Birhanu Z, Godesso A, Kebede Y, Gerbaba M. Mothers' experiences and satisfactions with health extension program in Jimma zone, Ethiopia: a cross sectional study. BMC Health Serv Res. 2013 Feb 21;13:74. doi: 10.1186/1472-6963-13-74.

  PMID: 23433479 BACKGROUND

• Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.

  PMID: 22263004 BACKGROUND

• MacArthur C, Winter HR, Bick DE, Knowles H, Lilford R, Henderson C, Lancashire RJ, Braunholtz DA, Gee H. Effects of redesigned community postnatal care on womens' health 4 months after birth: a cluster randomised controlled trial. Lancet. 2002 Feb 2;359(9304):378-85. doi: 10.1016/s0140-6736(02)07596-7.

  PMID: 11844507 BACKGROUND

• Donner A, Birkett N, Buck C. Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol. 1981 Dec;114(6):906-14. doi: 10.1093/oxfordjournals.aje.a113261. No abstract available.

  PMID: 7315838 BACKGROUND

• Stanton C, Blanc AK, Croft T, Choi Y. Skilled care at birth in the developing world: progress to date and strategies for expanding coverage. J Biosoc Sci. 2007 Jan;39(1):109-20. doi: 10.1017/S0021932006001271. Epub 2006 Mar 8.

  PMID: 16522226 BACKGROUND

• Zerfu TA, Taddese H, Nigatu T, Tenkolu G, Khan DN, Biadgilign S, Deribew A. Is deployment of trained nurses to rural villages a remedy for the low skilled birth attendance in Ethiopia? A cluster randomized-controlled community trial. PLoS One. 2018 Oct 12;13(10):e0204986. doi: 10.1371/journal.pone.0204986. eCollection 2018.

  PMID: 30312309 DERIVED

• Zerfu TA, Ayele HT, Bogale TN. Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long-Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial. Stud Fam Plann. 2018 Jun;49(2):115-126. doi: 10.1111/sifp.12054. Epub 2018 May 21.

  PMID: 29781525 DERIVED

• Zerfu TA, Taddese H, Nigatu T, Tenkolu G, Vogel JP, Khan-Neelofur D, Biadgilign S, Deribew A. Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol. BMC Health Serv Res. 2017 Jan 26;17(1):85. doi: 10.1186/s12913-017-2041-6.

  PMID: 28122555 DERIVED

Study Officials

• Taddese Alemu, PhD

  Dilla University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: CORN were assigned into three arms namely: HP, HC and control arms

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 17, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

ET (1)