Rationale & design of the PROMISES study: a prospective assessment and validation study of salivary progesterone as a test for preterm birth in pregnant women from rural India.

Background: In India, 3.6 million pregnancies are affected by preterm birth annually, with many infants dying or surviving with disability. Currently, there is no simple test available for screening all women at risk of spontaneous PTB in low income setting, although high resource settings routinely use cervical length measurement and cervico-vaginal fluid fetal fibronectin for identification and care of women at risk due to clinical history. In rural India, where the public health system has limited infrastructure, trained staff and equipment, there is a greater need to develop a low-cost screening approach for providing early referral, treatment and remedial support for pregnant women at risk of preterm birth. There is interest in the use of a salivary progesterone test as a screening tool preliminary evidence from India, Egypt and UK has shown promise for this type of test. The test requires further validation in a low resource community setting.

Methods: The Promises study aims to validate and test the feasibility of introducing a low-cost salivary progesterone preterm birth prediction test in two rural districts in India with high rates of prematurity. It is a prospective study of 2000 pregnant women recruited from Panna and Satna in Madhya Pradesh over approximately 24 months. Demographic and pregnancy outcome data will be collected, and pregnancies will be dated by ultrasound sonography. Saliva progesterone will be measured by ELISA in samples obtained between 24-28 weeks of gestation. The association between salivary progesterone and preterm birth will be determined and the utility of salivary progesterone to predict preterm birth < 34, as well as < 30 and < 37 weeks assessed. Additional qualitative data will be obtained in terms of acceptability and feasibility of saliva progesterone testing and knowledge of PTB.

Discussion: A validated cost-effective saliva test, which has potential for further adaptation to a 'point of care' setting will allow early identification of pregnant women at risk of preterm birth, who can be linked to an effective pathway of care and support to reduce preterm birth and associated adverse consequences. This will reduce both economic and emotional burden on the affected women and their families.