Maternal DeathAccelerateNCT02468310
Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana
A study testing Maternal and neonatal emergency protocols in people with Maternal Death and Neonatal Death, run by Hannah Brown Amoakoh at 1 site in Ghana.
Trial summary
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maternal Death, Neonatal Death, Postpartum Haemorrhage
- What is being tested?
- Maternal and neonatal emergency protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,831 participants
- Where
- 1 siteGhana
- Study dates
- 10 Aug 2015to 9 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- District location in the Eastern region of Ghana.
- The districts should have an expected deliveries of ≥ 1,100 / year
- The District Health Management Team and the District Hospital Management Team must agree to participate in the study.
Who cannot join
- District location outside the Eastern region.
- The districts expected deliveries of <1,100 / year
- The District Health Management Team and the District Hospital Management Team disagreeing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of Clinical Decision Making Support Systems on Maternal and Neonatal Mortality and Morbidity in Ghana: a Cluster Randomized Controlled Trial
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas.
Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality.
Read more
Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used.
Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.
Read the detailed description
Rationale of Study Based on the preponderance of evidence provided so far, Ghana is not on track for MDG 4 \& 5.31 Despite increased antenatal care attendance in the health facilities,and the number of pregnancy delivered by skilled health care workers,neonatal and maternal mortality have not seen the needed decline.
Maternal deaths and neonatal deaths are caused by a complex interaction of economic, financial, social, cultural and clinical factors. Clinical factors are related to access to and quality of antenatal care, skilled attendance at delivery and emergency obstetric care. With over 90% of pregnant women receiving antenatal care from a health professional,it is believed that if adequate care is offered to these women, birth outcomes will be improved. Gaps identified in the quality of care given to pregnant women include poor quality of clinical decision guiding provider decisions on management choices.
Considering this we propose an evidence-based intervention facilitating easy access to maternal and neonatal guidelines for routine and emergency obstetric and antenatal/neonatal care for frontline providers, in public facilities. For the purpose of this intervention, we have chosen as a reference guideline the national Safe Motherhood protocol,an elaborate tool, that provides detailed state-of-the-art guidelines for maternal and newborn care, starting from prenatal care, through antenatal, delivery, postpartum, and newborn care. We chose text messaging based on the Unstructured Supplementary Service Data (USSD) system as a low-cost, easily-accessible and instant way of requesting needed information in standard and emergency situations by the health care provider to enhance clinical decision making.
Objectives Primary objective
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal mortality Secondary objectives
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal mortality
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal morbidity
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal morbidity
- To assess adherence of health care providers to clinical guidelines for maternal antenatal care
Study design A cluster randomized controlled trial49 design will be used to examine the effect of CDMSS in the form of USSD-based text messaging of standard protocols for the management of maternal and neonatal care to providers, on neonatal and maternal mortality in the Eastern region, Ghana. This research is planned to commence in January 2015 and end in June 2016. Each of the districts in the region will be the cluster unit of randomization. This design was adopted in order to avoid contamination both at the patient and health professional levels, which may occur as a result of social interaction.
After randomization, a baseline study will be conducted in the districts and facilities to collect data on district and facility characteristics, while baseline measures of the chosen outcomes will be obtained from the District Health Information Management System - 2 (DHIMS - 2) which has been shown to provide accurate estimates of neonatal health indicators.50 This will take place from November to December 2014. The baseline study will be followed by the intervention study that will run for a period of 18 months. During this period monthly monitoring, including data collection of the outcome measures will be carried out by the study team. In addition, a quality of care study, done by assessment of provider adherence to the guidelines sent through the SMS text messaging will be conducted in 2 selected districts each from the intervention and control districts, through a record review of a random sample of clients seen during the period. The process of implementation of the intervention will be documented. At the end of the intervention period, a post intervention evaluation will be carried out at the district and facility level.
- Conditions
- Maternal Death, Neonatal Death, Postpartum Haemorrhage, Pre-eclampsia, Eclampsia, Pregnancy Induced Hypertension
- Being tested
- Maternal and neonatal emergency protocols
- Keywords
- Maternal mortality, Neonatal mortality, Neonatal morbidity, Text messaging, Clinical decision making, Maternal Morbidity
- Medical subject headings
- Maternal Death, Perinatal Death, Postpartum Hemorrhage, Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced, Puerperal Infection, Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal and neonatal emergency protocolsOther
Also called Protocols for Maternal and Neonatal emergencies
Protocols for management of Maternal and Neonatal emergencies based on the Safe Motherhood protocol adopted by the Ghana Health Service to improve maternal and neonatal health
| Study group | Role | What they receive |
|---|---|---|
| Intervention districts | Experimental | Access to protocols for management of obstetric and neonatal emergencies via text messaging on request in Intervention districts. Maternal and Neonatal emergency protocols Receives: Other: Maternal and neonatal emergency protocols |
| Control districts | No intervention | No access to protocols for management of obstetric and neonatal emergencies via text messaging in control district |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonatal deaths
Total number of neonatal deaths among total number of deliveries over an 18 month period
Measured: 18 months
Secondary outcomes (8)
Number of maternal deaths
Total number of maternal deaths among total antenatal attendants over an 18 month period
Measured: 18 months
Number of cases of eclampsia
Total number of cases of eclampsia among total antenatal attendants over an 18 month period
Measured: 18 months
Number of cases of postpartum haemorrhage
Total number of cases of postpartum haemorrhage among total antenatal attendants over an 18 month period
Measured: 18 months
Number of cases of prolonged labour
Total number of cases of prolonged labour among total antenatal attendants over an 18 month period
Measured: 18 months
Number of cases of puerperal sepsis
Total number of cases of puerperal sepsis among total antenatal attendants over an 18 month period
Measured: 18 months
Number of cases of birth asphyxia among deliveries
Total number of cases of birth asphyxia among total deliveries over an 18 month period
Measured: 18 months
Number of cases of low birth weight deliveries
Total number of cases of low birth deliveries among total deliveries over an 18 month period
Measured: 18 months
Number of cases of cord sepsis
Total number of cases of cord sepsis among total deliveries over an 18 month period
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start10 Aug 2015
- Primary completion9 Feb 2017
- Study completion9 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannah Brown Amoakoh
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Services, University of Ghana
- Responsible party
- Sponsor-investigator, Hannah Brown Amoakoh, Julius Global Health
- Investigators
- Irene Agyepong, MD DRPH PhD, Principal investigator, Julius Center University of Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468310
- Sponsor's protocol ID
- GHS-ERC: 10/09/14
- Acronym
- Accelerate
- Status last verified
- Aug 2017
- First submitted
- 7 Jun 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Permission needs to be sought from Ghanaian health authorities first.
Publications
Amoakoh HB, Klipstein-Grobusch K, Agyepong IA, Zuithoff NPA, Amoakoh-Coleman M, Kayode GA, Sarpong C, Reitsma JB, Grobbee DE, Ansah EK. The effect of an mHealth clinical decision-making support system on neonatal mortality in a low resource setting: A cluster-randomized controlled trial. EClinicalMedicine. 2019 Jul 4;12:31-42. doi: 10.1016/j.eclinm.2019.05.010. eCollection 2019 Jul.
PubMed 31388661Amoakoh HB, Klipstein-Grobusch K, Amoakoh-Coleman M, Agyepong IA, Kayode GA, Sarpong C, Grobbee DE, Ansah EK. 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. Trials. 2017 Apr 4;18(1):157. doi: 10.1186/s13063-017-1897-4.
PubMed 28372580
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Clinical Decision Making Support Systems on Maternal and Neonatal Mortality and Morbidity in Ghana: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02468310
- Acronym / sponsor ID
- Accelerate / GHS-ERC: 10/09/14
- Conditions
- Maternal Death, Neonatal Death, Postpartum Haemorrhage, Pre-eclampsia, Eclampsia, Pregnancy Induced Hypertension
- Keywords
- Maternal mortality, Neonatal mortality, Neonatal morbidity, Text messaging, Clinical decision making, Maternal Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65,831 participants (actual)
- Lead sponsor
- Hannah Brown AmoakohUniversity, hospital or other
- Collaborators
- Ghana Health Services, University of Ghana
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Apr 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas.
Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality.
Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used.
Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.
Detailed description
Rationale of Study Based on the preponderance of evidence provided so far, Ghana is not on track for MDG 4 \& 5.31 Despite increased antenatal care attendance in the health facilities,and the number of pregnancy delivered by skilled health care workers,neonatal and maternal mortality have not seen the needed decline.
Maternal deaths and neonatal deaths are caused by a complex interaction of economic, financial, social, cultural and clinical factors. Clinical factors are related to access to and quality of antenatal care, skilled attendance at delivery and emergency obstetric care. With over 90% of pregnant women receiving antenatal care from a health professional,it is believed that if adequate care is offered to these women, birth outcomes will be improved. Gaps identified in the quality of care given to pregnant women include poor quality of clinical decision guiding provider decisions on management choices.
Considering this we propose an evidence-based intervention facilitating easy access to maternal and neonatal guidelines for routine and emergency obstetric and antenatal/neonatal care for frontline providers, in public facilities. For the purpose of this intervention, we have chosen as a reference guideline the national Safe Motherhood protocol,an elaborate tool, that provides detailed state-of-the-art guidelines for maternal and newborn care, starting from prenatal care, through antenatal, delivery, postpartum, and newborn care. We chose text messaging based on the Unstructured Supplementary Service Data (USSD) system as a low-cost, easily-accessible and instant way of requesting needed information in standard and emergency situations by the health care provider to enhance clinical decision making.
Objectives Primary objective
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal mortality Secondary objectives
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal mortality
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal morbidity
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal morbidity
- To assess adherence of health care providers to clinical guidelines for maternal antenatal care
Study design A cluster randomized controlled trial49 design will be used to examine the effect of CDMSS in the form of USSD-based text messaging of standard protocols for the management of maternal and neonatal care to providers, on neonatal and maternal mortality in the Eastern region, Ghana. This research is planned to commence in January 2015 and end in June 2016. Each of the districts in the region will be the cluster unit of randomization. This design was adopted in order to avoid contamination both at the patient and health professional levels, which may occur as a result of social interaction.
After randomization, a baseline study will be conducted in the districts and facilities to collect data on district and facility characteristics, while baseline measures of the chosen outcomes will be obtained from the District Health Information Management System - 2 (DHIMS - 2) which has been shown to provide accurate estimates of neonatal health indicators.50 This will take place from November to December 2014. The baseline study will be followed by the intervention study that will run for a period of 18 months. During this period monthly monitoring, including data collection of the outcome measures will be carried out by the study team. In addition, a quality of care study, done by assessment of provider adherence to the guidelines sent through the SMS text messaging will be conducted in 2 selected districts each from the intervention and control districts, through a record review of a random sample of clients seen during the period. The process of implementation of the intervention will be documented. At the end of the intervention period, a post intervention evaluation will be carried out at the district and facility level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention districts | Experimental | Other: Maternal and neonatal emergency protocolsAccess to protocols for management of obstetric and neonatal emergencies via text messaging on request in Intervention districts. Maternal and Neonatal emergency protocols |
| Control districts | No intervention | –No access to protocols for management of obstetric and neonatal emergencies via text messaging in control district |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- District location in the Eastern region of Ghana.
- The districts should have an expected deliveries of ≥ 1,100 / year
- The District Health Management Team and the District Hospital Management Team must agree to participate in the study.
Key exclusion criteria (3 listed)
- District location outside the Eastern region.
- The districts expected deliveries of <1,100 / year
- The District Health Management Team and the District Hospital Management Team disagreeing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal and neonatal emergency protocolsAlso: Protocols for Maternal and Neonatal emergenciesProtocols for management of Maternal and Neonatal emergencies based on the Safe Motherhood protocol adopted by the Ghana Health Service to improve maternal and neonatal health | Other | Intervention districts |
Primary outcome
Number of neonatal deaths
Time frame: 18 months
Total number of neonatal deaths among total number of deliveries over an 18 month period
8 secondary outcomes
Number of maternal deaths
Time frame: 18 months
Number of cases of eclampsia
Time frame: 18 months
Number of cases of postpartum haemorrhage
Time frame: 18 months
Number of cases of prolonged labour
Time frame: 18 months
Number of cases of puerperal sepsis
Time frame: 18 months
Number of cases of birth asphyxia among deliveries
Time frame: 18 months
Number of cases of low birth weight deliveries
Time frame: 18 months
Number of cases of cord sepsis
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 31388661Amoakoh HB, Klipstein-Grobusch K, Agyepong IA, Zuithoff NPA, Amoakoh-Coleman M, Kayode GA, Sarpong C, Reitsma JB, Grobbee DE, Ansah EK. The effect of an mHealth clinical decision-making support system on neonatal mortality in a low resource setting: A cluster-randomized controlled trial. EClinicalMedicine. 2019 Jul 4;12:31-42. doi: 10.1016/j.eclinm.2019.05.010. eCollection 2019 Jul.
- Derived from this study: PubMed 28372580Amoakoh HB, Klipstein-Grobusch K, Amoakoh-Coleman M, Agyepong IA, Kayode GA, Sarpong C, Grobbee DE, Ansah EK. 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. Trials. 2017 Apr 4;18(1):157. doi: 10.1186/s13063-017-1897-4.
- Individual participant dataSharing planned: Undecided. Permission needs to be sought from Ghanaian health authorities first.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Agyepong, MD DRPH PhD principal investigator
Julius Center University of Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal and neonatal emergency protocols in people with Maternal Death and Neonatal Death, run by Hannah Brown Amoakoh at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonatal deaths (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02468310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.