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Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana (Accelerate)

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ClinicalTrials.gov Identifier: NCT02468310
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Ghana Health Services
University of Ghana
Information provided by (Responsible Party):
Hannah Brown Amoakoh, Julius Global Health

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Maternal Death Neonatal Death Postpartum Haemorrhage Pre-eclampsia Eclampsia Pregnancy Induced Hypertension Puerperal Sepsis Asphyxia Neonatal Sepsis Neonatal Jaundice Other: Maternal and neonatal emergency protocols Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : August 10, 2015
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : April 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention districts
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
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
Other Name: Protocols for Maternal and Neonatal emergencies

No Intervention: Control districts
No access to protocols for management of obstetric and neonatal emergencies via text messaging in control district



Primary Outcome Measures :
  1. Number of neonatal deaths [ Time Frame: 18 months ]
    Total number of neonatal deaths among total number of deliveries over an 18 month period


Secondary Outcome Measures :
  1. Number of maternal deaths [ Time Frame: 18 months ]
    Total number of maternal deaths among total antenatal attendants over an 18 month period

  2. Number of cases of eclampsia [ Time Frame: 18 months ]
    Total number of cases of eclampsia among total antenatal attendants over an 18 month period

  3. Number of cases of postpartum haemorrhage [ Time Frame: 18 months ]
    Total number of cases of postpartum haemorrhage among total antenatal attendants over an 18 month period

  4. Number of cases of prolonged labour [ Time Frame: 18 months ]
    Total number of cases of prolonged labour among total antenatal attendants over an 18 month period

  5. Number of cases of puerperal sepsis [ Time Frame: 18 months ]
    Total number of cases of puerperal sepsis among total antenatal attendants over an 18 month period

  6. Number of cases of birth asphyxia among deliveries [ Time Frame: 18 months ]
    Total number of cases of birth asphyxia among total deliveries over an 18 month period

  7. Number of cases of low birth weight deliveries [ Time Frame: 18 months ]
    Total number of cases of low birth deliveries among total deliveries over an 18 month period

  8. Number of cases of cord sepsis [ Time Frame: 18 months ]
    Total number of cases of cord sepsis among total deliveries over an 18 month period


Other Outcome Measures:
  1. Percentage of cases of pre-eclampsia/Pregnancy induced hypertension appropriately managed [ Time Frame: 18 months ]
    This will measure the percentage of cases of pre-eclampsia/pregnancy induced hypertension managed according to the Safe Motherhood Protocol

  2. Percentage of cases of birth asphyxia appropriately managed [ Time Frame: 18 months ]
    This will measure the percentage of cases of birth asphyxia managed according to the Safe Motherhood Protocol



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02468310


Locations
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Ghana
Eastern Region Health directorate
Koforidua, Ghana, P.O Box 175
Sponsors and Collaborators
Hannah Brown Amoakoh
Ghana Health Services
University of Ghana
Investigators
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Principal Investigator: Irene Agyepong, MD DRPH PhD Julius Center University of Utrecht
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hannah Brown Amoakoh, Clinical trials coordinator, Julius Global Health
ClinicalTrials.gov Identifier: NCT02468310    
Other Study ID Numbers: GHS-ERC: 10/09/14
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Permission needs to be sought from Ghanaian health authorities first.
Keywords provided by Hannah Brown Amoakoh, Julius Global Health:
Maternal mortality
Neonatal mortality
Neonatal morbidity
Text messaging
Clinical decision making
Maternal Morbidity
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Postpartum Hemorrhage
Eclampsia
Pre-Eclampsia
Perinatal Death
Hypertension, Pregnancy-Induced
Maternal Death
Jaundice, Neonatal
Hemorrhage
Death
Jaundice
Asphyxia
Hypertension
Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Hyperbilirubinemia
Skin Manifestations
Infant, Newborn, Diseases
Wounds and Injuries
Hyperbilirubinemia, Neonatal