Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. The key pharmaceutical components of the PPH managment  are oxytocin and TXA.  Quality of oxytocin at the point of sale  has been found to be below the specifications. There are currently no quality assessment studies of TXA.

Objective: To evaluate the quality of oxytocin and TXA products at the study facilities in six countries.

Methods: Laboratory based analytical study in which samples of oxytocin and TXA will be collected from participating sites and analyzed in a central research laboratory. Samples will be tested for appearance, identity, assay, related substances, and PH as per International Pharmacopeia specifications. Laboratory procedures will be blinded, and packaging and labelling assessment will not be conducted by the same person who carries out the chemical tests.

Analysis: Results of the visual inspection and chemical results will be entered in the Analytical test report form. The International Pharmacopeia will be the reference for the evaluation of the oxytocin results and the British Pharmacopeia for TXA. This will allow comparison of samples from different manufacturers. This specification will be used to decide on compliance or non-compliance of the tested samples for the purpose of this study. Non-compliance with the specifications selected for this study will not imply non-compliance with the specifications approved in the country, but it will indicate the need to look at the product more closely.

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. The WHO led the development of a PPH first response treatment bundle based on existing recommendations and the effectiveness of the bundle will be the subject of the E-MOTIVE implementation research. The key pharmaceutical components of the bundle are oxytocin and TXA. Several studies looked at the quality of oxytocin at the point of sale and found that in many places the active pharmaceutical ingredient was below the specifications. There are currently no quality assessment studies of TXA.

Objective: To evaluate the quality of oxytocin and TXA products at the study facilities in six countries.

Methods: Laboratory based analytical study in which samples of oxytocin and TXA will be collected from participating sites and analyzed in a central research laboratory. Before sample collection, all manufacturers and products used in the study facilities will be mapped according to their registration status within the country and label instructions. We will not test the products in countries where there is one government approved procured product and those products that are SRA approved or WHO prequalified product. The ampoules will be shipped to the testing laboratory by a courier service and transported in such a way as to avoid damage during transportation. Oxytocin samples will be transported at 2-8°C and freezing will be avoided. Both oxytocin and TXA samples will be tested at Monash Institute of Pharmaceutical Sciences at Monash University, Australia. The laboratory will start testing only when all the samples are received. Testing methods and specifications will follow the International Pharmacopeia for oxytocin and the British Pharmacopeia for TXA. Samples will be tested for appearance, identity, assay, related substances, and PH as per International Pharmacopeia specifications. Laboratory procedures will be blinded, and packaging and labelling assessment will not be conducted by the same person who carries out the chemical tests.

Analysis: Results of the visual inspection and chemical results will be entered in the Analytical test report form. The International Pharmacopeia will be the reference for the evaluation of the oxytocin results and the British Pharmacopeia for TXA. This will allow comparison of samples from different manufacturers. This specification will be used to decide on compliance or non-compliance of the tested samples for the purpose of this study. Non-compliance with the specifications selected for this study will not imply non-compliance with the specifications approved in the country, but it will indicate the need to look at the product more closely.