Pharmacy and Poisons Board
Protocol No: ECCT/24/01/02 Date of Protocol: 27-09-2023
Study Title:

Implementation of WHO recommendations for drugs and approaches to prevent and treat postpartum hemorrhage: a multi-country feasibility, acceptability and cost-effectiveness study
Study Objectives:

General objective

The general objective is to generate evidence on the feasibility, acceptability and cost-effectiveness of expanding the package of drugs and approaches available to implement WHO recommendations for PPH prevention and treatment in selected high-burden countries.

 

Specific objectives

  1. Assess the feasibility and acceptability of advance distribution of misoprostol for self-administration to prevent PPH at births outside of health facilities in selected project sites;
  2. Assess the feasibility and acceptability of introducing heat-stable carbetocin (HSC) for PPH prevention and tranexamic acid (TXA) for PPH treatment at health centers and hospitals in selected project sites;
  3. Assess the cost-effectiveness of the combined implementation of advance distribution of misoprostol for self-administration to prevent PPH at births outside of health facilities, as well as HSC for PPH prevention and TXA for PPH treatment at health facilities; and
  4. Examine how and why barriers and enablers to expanding the package of drugs and approaches for PPH prevention and treatment vary within and across selected project sites in four countries
Laymans Summary:
Jhpiego through the Accelerating Measurable Progress and Leveraging Investments for Postpartum Hemorrhage Impact (AMPLI_PPHI) project in collaboration with Division of reproductive and maternal health and Makueni county (department of health) plans to carry out a multi-country study to assess implementation of WHO recommendations for drugs and approaches to prevent and treat postpartum hemorrhage.
The purpose of this study is to assess feasibility and acceptability of expanding the package of drugs and approaches available to prevent and treat postpartum hemorrhage in 36 select health facilities in Makueni county. The study participants will involve postpartum women, community representatives, healthcare providers and key MNH stakeholders who have been consented to be in the study. An inclusion and exclusion criteria will be used to determine the eligibility of the study participants.
The findings from this study will be used inform government decisions on where and how to introduce an expanded package of WHO-recommended drugs and approaches for PPH prevention and treatment. Study participants and people living in study locations may benefit from improved health services if study findings stimulate policy change and resource allocation. Research findings are also intended to inform WHO guidance on operationalizing PPH-related recommendations
Abstract of Study:

Full title

Implementation of WHO recommendations for drugs and approaches to prevent and treat postpartum hemorrhage: a multi-country feasibility, acceptability and cost-effectiveness study

Short title

AMPLI-PPHI implementation research protocol

Countries

Democratic Republic of the Congo, Guinea, India, Kenya    

Timeline

24 months (anticipated January 2024 – December 2025)

Goal

To generate evidence on the feasibility, acceptability and cost-effectiveness of expanding the package of drugs and approaches available to implement WHO recommendations for postpartum hemorrhage prevention and treatment in high-burden countries

Research objectives
  1. Assess the feasibility and acceptability of advance distribution of misoprostol for self-administration to prevent postpartum hemorrhage at births outside of health facilities in selected project sites;

 

  1. Assess the feasibility and acceptability of introducing heat-stable carbetocin for postpartum hemorrhage prevention and tranexamic acid for postpartum hemorrhage treatment at health centers and hospitals in selected project sites;

 

  1. Assess the cost-effectiveness of the combined implementation of advance distribution of misoprostol for self-administration to prevent postpartum hemorrhage at births outside of health facilities, as well as heat-stable carbetocin for postpartum hemorrhage prevention and tranexamic acid for postpartum hemorrhage treatment at health facilities; and

 

  1. Examine how and why barriers and enablers to expanding the package of drugs and approaches for postpartum hemorrhage prevention and treatment vary within and across selected project sites in four countries.

Methods

The proposed study is a multi-country mixed-methods implementation research study. Convergent qualitative and quantitative methods will be used to address each objective. For objectives 1 and 2, the feasibility and acceptability of expanding the package of drugs and approaches available to prevent and treat postpartum hemorrhage in each study site will be assessed through secondary analysis of routine health service statistics and program documentation, complemented by primary qualitative data collection to capture the experiences and perspectives of those involved in the introduction and operationalization of updated PPH prevention and treatment protocols. For objective 3, an economic evaluation will be conducted to determine the incremental cost-effectiveness of an expanded package of PPH drugs and approaches compared with the current standard of care for PPH prevention and treatment in each country.  For objective 4, within and cross-country variation in barriers and enablers to expanding the package of drugs and approaches for PPH prevention and treatment will be explored through secondary analysis of program documentation, complemented by primary qualitative data collection at the community, facility and health system levels.

Expected Outcomes

AMPLI-PPHI will support Ministries of Health in each country to use study findings to update national policies/guidelines/protocols (where applicable) and catalyze adoption of WHO-recommendations for PPH prevention and treatment.  Study findings will also be disseminated through learning exchanges organized with the Ministry of Health, health professional associations and other stakeholders in neighboring countries to accelerate adoption of recommendations and translation of policies into practice. Wider dissemination of findings will be done through scientific meetings or conferences as well as publications in peer reviewed journals, and aim to inform iterative updates of WHO guidance relating to PPH as well as investments in addressing bottlenecks in implementing evidence-based interventions to address maternal mortality and morbidity.