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

NCT02468310 | Completed

• 1 other identifier: GHS-ERC: 10/09/14
• Study Type: interventional
• Target: 65,831
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Death; Neonatal Death; Postpartum Haemorrhage; Pre-eclampsia; Eclampsia; Pregnancy Induced Hypertension; Puerperal Sepsis; Asphyxia; Neonatal Sepsis; Neonatal Jaundice

Keywords

Maternal mortality; Neonatal mortality; Neonatal morbidity; Text messaging; Clinical decision making; Maternal Morbidity

Outcome Measures

Primary Outcomes (1)

• Number of neonatal deaths

  Total number of neonatal deaths among total number of deliveries over an 18 month period

  18 months

Secondary Outcomes (8)

• Number of maternal deaths

  18 months

• Number of cases of eclampsia

  18 months

• Number of cases of postpartum haemorrhage

  18 months

• Number of cases of prolonged labour

  18 months

• Number of cases of puerperal sepsis

  18 months

Other Outcomes (2)

• Percentage of cases of pre-eclampsia/Pregnancy induced hypertension appropriately managed

  18 months

• Percentage of cases of birth asphyxia appropriately managed

  18 months

Study Arms (2)

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

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

Interventions

Maternal and neonatal emergency protocols OTHER

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

Intervention districts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hannah Brown Amoakoh: lead
• Ghana Health Services: collaborator
• University of Ghana: collaborator

Study Sites (1)

Eastern Region Health directorate

Koforidua, P.O Box 175, Ghana

Location

Related Publications (2)

• 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.

  PMID: 31388661 DERIVED

• Amoakoh 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.

  PMID: 28372580 DERIVED

MeSH Terms

Conditions

Maternal Death; Perinatal Death; Postpartum Hemorrhage; Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced; Puerperal Infection; Asphyxia; Neonatal Sepsis; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications, Infectious; Infections; Wounds and Injuries; Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Study Officials

• Irene Agyepong, MD DRPH PhD

  Julius Center University of Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical trials coordinator

Study Record Dates

• First Submitted: June 7, 2015
• First Posted: June 10, 2015
• Study Start: August 10, 2015
• Primary Completion: February 9, 2017
• Study Completion: April 9, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

GH (1)