Anti-D (Rh) Antibodies Affecting Care of Mother Clinical Trial
Official title:
Early Identification of Rh Negative Women During Pregnancy and Use of Prophylaxis to Prevent Rh Disease of Newborns in Dadu District, Sindh, Pakistan
The investigators aim to demonstrate the feasibility of point-of-care identification of Rh-negative women in a poor, rural setting in Pakistan. Feasibility will be assessed across 2 major domains: 1) acceptance by pregnant women to receive the point-of-care test; and, 2) ability of health workers to administer the point of care test and interpret results. The investigators will also measure whether RhIg prophylaxis can be successfully delivered and is accepted by pregnant women in this setting. The socio-demographic correlates of the acceptance of point-of-care testing and where applicable, the acceptance of RhIg prophylaxis will also be assessed. In addition, the investigators will also explore the baseline knowledge of Rh disease among pregnant women and lady health visitors in this study population and will investigate socio-demographic correlates of baseline knowledge and the uptake of knowledge among pregnant women. Finally, the prevalence of Rh negativity will be calculated and stillbirth and neonatal mortality will be tracked among all participants. All stillbirths and neonatal deaths in this population will be characterized with respect to cause and Rh-negativity.
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.
To address one of our study aims, a single questionnaire will be administered to a cadre of
approximately 30 health professionals (i.e., physicians, lady health visitors, nurses, etc.)
who are not otherwise engaged in study activities.
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