Early Identification of Rh Negative Women During Pregnancy and Use of Prophylaxis to Prevent Rh Disease of Newborns in Dadu District, Sindh, Pakistan

Rhesus (Rh) disease is a preventable condition caused by an incompatibility between maternal and fetal red blood cells (RBCs). If a person's RBCs lacks a certain protein s/he is said to be Rh-negative. Similarly, if a person's RBCs have that same protein, s/he is said to be Rh-positive. If a pregnant woman's is Rh-negative and her fetus is Rh-positive, the baby is at risk of Rh disease. The complications associated with Rh disease include miscarriage, stillbirth, and neonatal death. Among surviving newborns, Rh disease can cause anemia (low RBCs, which can appear as feeling tired or weak or having a shortness of breath), jaundice (yellowing of the skin), and brain damage. If Rh-negative women are identified, there is a very high chance that Rh disease of the newborn can be prevented.

The purpose of this study is to demonstrate the feasibility of point-of-care identification of Rh-negative women in Dadu district, Pakistan. Determining the Rh status of pregnant women is the first step towards prevention of Rh disease of the newborn. By collecting information about a) the Rh status and blood type of pregnant women; b) the acceptability of a point of care test blood test of Rh disease; and, c) the acceptability of treatment for Rh negativity in pregnant women, the investigators will be able to improve antenatal care and prevent Rh disease of the newborn in rural settings. The implementation of a point-of-care Rh test will allow us for the identification of Rh-negative women, prompt provision of treatment, and prevention of Rh disease of the newborn in rural settings in Pakistan.

As part of this study, participants will be asked a series of questions to assess reproductive history of pregnant women and other demographic characteristics (i.e. questions about home environment and lifestyle). The investigators will also ask whether they are willing to provide a drop of blood, collected via finger prick, to allow us to determine your Rh status by ELDONCARD. If Rh test reveals that the pregnant women are Rh negative, the investigators will offer them up to two doses of treatment, first at approximately 28 weeks of gestation and again within 72 hours of delivery. The injections will be administered at the health facility. They will also be asked to undergo an ultrasound procedure by a trained technician at health facility. Moreover, after the newborn is delivered, the investigators will also ask a series of question and perform an in-person assessment of newborn to assess their health within 72 hours of delivery and then again on their 29th day of life. If they are found to be Rh-negative and they have a miscarriage, stillbirth, or baby dies within the first month of life, the investigators will ask them if we can collect a sample of their blood for further testing.

The investigators will conduct a prospective cohort study in Tehsil Headquarter Hospital (THQ) and District Headquarter Hospital (DHQ) that are situated in Dadu District, Sindh, Pakistan. In total, between 3 and 5 Lady Health Visitors (LHVs) will be enrolled at the study THQ and DHQ to administer the point-of-care test and if necessary, prophylaxis. Over the course of the study period, approximately 2000 pregnant women will be enrolled in total (across both study sites); liveborn newborns delivered to enrolled pregnant women will be followed for the first month of life. The sample size of 2000 pregnant women in this study is driven by the estimated prevalence of Rh negativity in the population (7%) and hence, the number of women investigators expect to offer two injections of RhIg (n=140). A sample size of 140 participants will enable us to measure the acceptance RhIg by pregnant women.

This prospective cohort will include two groups of participants: a) between 3 and 5 LHVs who are full time employees at THQ Johi and DHQ Dadu and, b) 2000 pregnant women from the communities in the catchment area of THQ Johi and DHQ Dadu.