Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Authors: Hannah Brown Amoakoh, Kerstin Klipstein-Grobusch, Mary Amoakoh-Coleman, Irene Akua Agyepong, Gbenga A. Kayode, Charity Sarpong, Diederick E. Grobbee, Evelyn K. Ansah

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Mobile health (mHealth) presents one of the potential solutions to maximize health worker impact and efficiency in an effort to reach the Sustainable Development Goals 3.1 and 3.2, particularly in sub-Saharan African countries. Poor-quality clinical decision-making is known to be associated with poor pregnancy and birth outcomes. This study aims to assess the effect of a clinical decision-making support system (CDMSS) directed at frontline health care providers on neonatal and maternal health outcomes.

Methods/design

A cluster randomized controlled trial will be conducted in 16 eligible districts (clusters) in the Eastern Region of Ghana to assess the effect of an mHealth CDMSS for maternal and neonatal health care services on maternal and neonatal outcomes. The CDMSS intervention consists of an Unstructured Supplementary Service Data (USSD)-based text messaging of standard emergency obstetric and neonatal protocols to providers on their request. The primary outcome of the intervention is the incidence of institutional neonatal mortality. Outcomes will be assessed through an analysis of data on maternal and neonatal morbidity and mortality extracted from the District Health Information Management System-2 (DHIMS-2) and health facility-based records. The quality of maternal and neonatal health care will be assessed in two purposively selected clusters from each study arm.

Discussion

In this trial the effect of a mobile CDMSS on institutional maternal and neonatal health outcomes will be evaluated to generate evidence-based recommendations for the use of mobile CDMSS in Ghana and other West African countries.

Trial registration

ClinicalTrials.gov, identifier: NCT02468310. Registered on 7 September 2015; Pan African Clinical Trials Registry, identifier: PACTR20151200109​073. Registered on 9 December 2015 retrospectively from trial start date.
Appendix
Available only for authorised users
Literature
1.
2.
3.
4.
5.
6.
7.
Oestergaard MZ, Inoue M, Yoshida S, Mahanani WR, Gore FM, Cousens S, et al. Neonatal mortality levels for 193 countries in 2009 with trends since 1990: a systematic analysis of progress, projections, and priorities. PLoS Med. 2011;8(8):e1001080.CrossRefPubMedPubMedCentral
8.
9.
Rajaratnam JK, Marcus JR, Flaxman AD, Wang H, Levin-Rector A, Dwyer L, et al. Neonatal, postneonatal, childhood, and under-5 mortality for 187 countries, 1970–2010: a systematic analysis of progress towards Millennium Development Goal 4. Lancet (London, England). 2010;375:1988–2008. doi:10.​1016/​S0140-6736(10)60703-9.CrossRef
10.
11.
Hill K, Choi Y. Neonatal mortality in the developing world. Demogr Res. 2006;14:429–52.CrossRef
12.
13.
14.
Chandler CIR, Jones C, Boniface G, Juma K, Reyburn H, Whitty CJM. Guidelines and mindlines: why do clinical staff over-diagnose malaria in Tanzania? Qual Study. 2008;13:1–13. doi:10.​1186/​1475-2875-7-53.
15.
16.
Styles M, Cheyne H, O’Carroll R, Greig F, Dagge-Bell F, Niven C. The Scottish Trial of Refer or Keep (the STORK study): midwives’ intrapartum decision making. Midwifery. 2011;27:104–11.CrossRefPubMed
17.
18.
Amoakoh-Coleman M, Borgstein AB, Felicie S, Sondaal V, Miltenburg AS, Verwijs M, et al. Role of mHealth interventions targeting health care workers in improving maternal and neonatal care in low- and middle-income countries: a systematic review. J Med Internet Res [in Press].
19.
20.
21.
22.
Oyeyemi SO, Wynn R. The use of cell phones and radio communication systems to reduce delays in getting help for pregnant women in low- and middle-income countries: a scoping review. Glob Health Action. 2015;8:28887. doi:10.​3402/​gha.​v8.​28887.
23.
Hall CS, Fottrell E, Wilkinson S, Byass P. Assessing the impact of mHealth interventions in low- and middle-income countries what has been shown to work? Glob Health Action. 2014;7:1–12.
24.
Mahmud N, Rodriguez J, Nesbit J. A text message-based intervention to bridge the healthcare communication gap in the rural developing world. Technol Health Care. 2010;18:137–44.PubMed
25.
Lemay NV, Sullivan T, Jumbe B, Perry CP. Reaching remote health workers in Malawi: baseline assessment of a pilot mHealth intervention. J Health Commun. 2012;17(sup1):105–17.CrossRefPubMed
26.
27.
28.
29.
30.
Issah K, Nang-Beifubah A, Opoku C. Maternal and neonatal survival and mortality in the Upper West Region of Ghana. Int J Gynaecol Obstet. 2011;113:208–10.CrossRefPubMed
31.
Howe LD, Manu A, Tawiah-Agyemang C, Kirkwood BR, Hill Z. Developing a community-based neonatal care intervention: a health facility assessment to inform intervention design. Paediatr Perinat Epidemiol. 2011;25:192–200.CrossRefPubMed
32.
33.
34.
35.
36.
37.
38.
Chou D, Daelmans B, Jolivet RR, Kinney M, Say L. Ending preventable maternal and newborn mortality and stillbirths. BMJ. 2015:h4255. doi:10.​1136/​bmj.​h4255.
39.
Conde-Agudelo A, Díaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database of Systematic Reviews 2016, Issue 8. Art. No.: CD002771. doi: 10.​1002/​14651858.​CD002771.​pub4.
40.
Debes AK, Kohli A, Walker N, Edmond K, Mullany LC. Time to initiation of breastfeeding and neonatal mortality and morbidity: a systematic review. BMC Public Health. 2013;13 Suppl 3:S19.CrossRefPubMedPubMedCentral
41.
Imdad A, Mullany LC, Baqui AH, El Arifeen S, Tielsch JM, Khatry SK, et al. The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis. BMC Public Health. 2013;13 Suppl 3:S15. doi:10.​1186/​1471-2458-13-S3-S15.CrossRefPubMedPubMedCentral
42.
43.
44.
45.
Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011;12:151. doi:10.​1186/​1745-6215-12-151.CrossRefPubMedPubMedCentral
46.
Kayode GA, Amoakoh-Coleman M, Brown-Davies C, Grobbee DE, Agyepong IA, Ansah E, et al. Quantifying the validity of routine neonatal healthcare data in the greater Accra Region, Ghana. PLoS One. 2014;9.
47.
48.
49.
Leyrat C, Caille A, Foucher Y, Giraudeau B. Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic. BMC Med Res Methodol. 2016:1–13. doi:10.​1186/​s12874-015-0100-4.
50.
51.
52.
53.
Metadata
Title
The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial
Authors
Hannah Brown Amoakoh
Kerstin Klipstein-Grobusch
Mary Amoakoh-Coleman
Irene Akua Agyepong
Gbenga A. Kayode
Charity Sarpong
Diederick E. Grobbee
Evelyn K. Ansah
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1897-4

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Update

Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial

Study protocol

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial

Study protocol

Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial

Research

The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study

Methodology

Understanding the cluster randomised crossover design: a graphical illustration of the components of variation and a sample size tutorial

Study protocol

Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial