An interventional study of Maternal and neonatal emergency protocols in Maternal Death, Neonatal Death and Postpartum Haemorrhage, sponsored by Hannah Brown Amoakoh. Completed at 1 site in Ghana. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Hannah Brown Amoakoh · Not applicable, Interventional, and Health services research
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.
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
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's enrollment of 65,831 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →This is the only study on the registry with Hannah Brown Amoakoh as lead sponsor.
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Exclusion Criteria:
Access to protocols for management of obstetric and neonatal emergencies via text messaging on request in Intervention districts. Maternal and Neonatal emergency protocols
Other: Maternal and neonatal emergency protocols
No access to protocols for management of obstetric and neonatal emergencies via text messaging in control district
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
Also known as: Protocols for Maternal and Neonatal emergencies
Number of neonatal deaths
Total number of neonatal deaths among total number of deliveries over an 18 month period
Time frame: 18 months
Number of maternal deaths
Total number of maternal deaths among total antenatal attendants over an 18 month period
Time frame: 18 months
Number of cases of eclampsia
Total number of cases of eclampsia among total antenatal attendants over an 18 month period
Time frame: 18 months
Number of cases of postpartum haemorrhage
Total number of cases of postpartum haemorrhage among total antenatal attendants over an 18 month period
Time frame: 18 months
Number of cases of prolonged labour
Total number of cases of prolonged labour among total antenatal attendants over an 18 month period
Time frame: 18 months
Number of cases of puerperal sepsis
Total number of cases of puerperal sepsis among total antenatal attendants over an 18 month period
Time frame: 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
Time frame: 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
Time frame: 18 months
Number of cases of cord sepsis
Total number of cases of cord sepsis among total deliveries over an 18 month period
Time frame: 18 months
Percentage of cases of pre-eclampsia/Pregnancy induced hypertension appropriately managed
This will measure the percentage of cases of pre-eclampsia/pregnancy induced hypertension managed according to the Safe Motherhood Protocol
Time frame: 18 months
Percentage of cases of birth asphyxia appropriately managed
This will measure the percentage of cases of birth asphyxia managed according to the Safe Motherhood Protocol
Time frame: 18 months
Plan to share: Undecided — Permission needs to be sought from Ghanaian health authorities first.
Ran from Aug 2015 to primary completion in Feb 2017, 17 months.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's 17 months is below that.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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