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
NCT number | NCT03297671 |
Other study ID # | Rh Study |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 27, 2018 |
Est. completion date | February 28, 2020 |
Verified date | July 2020 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1654 |
Est. completion date | February 28, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility |
Inclusion criteria for pregnant women - Pregnant women who present to THQ Johi and DHQ Dadu for ANC - At least 13 weeks gestation (assessed using self-reported first day of last menstrual period) - Currently resides within one of 5 Union Council's surrounding THQ Johi and in the catchment area of DHQ Dadu at a fixed address - Intends to deliver and remain in study catchment area for 1-month after the delivery of their newborn(s) - Provides written informed consent - Was not previously enrolled in this study during a different pregnancy Exclusion criteria for pregnant women - Previously consented into this study - Reported that they previously had an anaphylactic reaction to an injection of an antibody blood product - Has any chronic disease related to the heart, liver, kidney, or lungs - Does not currently reside within the study's catchment area - Intends to deliver outside of the catchment area - Plans to relocate outside of the catchment area within 1-month after the delivery of their newborn(s) - Does not provide written consent Inclusion criteria for lady health visitors - Working full-time at THQ Johi and DHQ Dadu as a Lady Health Visitor - Verbal consent provided from LHV's direct supervisor - LHV provides verbal consent to complete a test on baseline knowledge of Rh disease and jaundice - LHV can attend a 1 day training and orientation session - LHV provides written informed consent to participate in study Exclusion criteria for health care workers - Verbal consent not provided from LHV's direct supervisor - Does not consent to completing a test on baseline knowledge of Rh disease and jaundice - Cannot attend a 1 day training and orientation session - Does not provide written informed consent to participate in study Non-study health care professional recruitment A convenience sample of approximately 30 health care professionals including physicians, LHVs, nurses, lady health workers, and midwives, who are not otherwise engaged in study activities will be identified and approached at THQ Johi, DHQ Dadu, and other surrounding health care facilities. To be eligible for participation, health care professionals must not be employed by the study or enrolled in the study as a participant. If health care professionals are determined eligible, they will be asked to complete a short questionnaire to assess their knowledge of Rh disease, similar to the questionnaire administered to LHVs. These health care professionals will not be enrolled into the study or followed prospectively and thus, only verbal consent will be obtained. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Taluka Headquarter Hospital Johi and District Headquarter Hospital Dadu | Dadu | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | Grand Challenges Canada, The Hospital for Sick Children |
Pakistan,
Biologicals, E. Clinical Evidence - Comparative Study of EldonCards. 2012
ELDON K. Simultaneous ABO and Rh groupings on cards in the laboratory or at the bedside. Dan Med Bull. 1955 Mar;2(2):33-40. — View Citation
Fung Kee Fung K, Eason E, Crane J, Armson A, De La Ronde S, Farine D, Keenan-Lindsay L, Leduc L, Reid GJ, Aerde JV, Wilson RD, Davies G, Désilets VA, Summers A, Wyatt P, Young DC; Maternal-Fetal Medicine Committee, Genetics Committee. Prevention of Rh all — View Citation
World Health Organization, U., Handbook IMCI. Integrated Management of Childhood Illness. 2005.
Zipursky A, Bhutani VK. Impact of Rhesus disease on the global problem of bilirubin-induced neurologic dysfunction. Semin Fetal Neonatal Med. 2015 Feb;20(1):2-5. doi: 10.1016/j.siny.2014.12.001. Epub 2015 Jan 9. Review. — View Citation
Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F84-5. doi: 10.1136/adc.2009.181172. Epub 2010 Oct 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of pregnant women who will accept the point of care ELDONCARD test | Acceptability of the point-of-care test will be represented as the proportion of positive (i.e., Yes) responses to each of the 6 questions listed below. The acceptability of the test between sites will be compared. Did the participant agree to have the point-of-care test? Do you think that having the point-of-care test will provide information that could improve the health of your newborn? Do you think the point-of-care test was safe? Did your family approve of you having the point-of-care test? Would you recommend the point of care test to other mothers in the village? In the future, would you agree to have this point of care test again? |
12 months | |
Secondary | Prevalence of Rhesus negativity in pregnant women | Prevalence of Rhesus negativity will be calculated from the total sample size of pregnant women (2000) for the study and the total number of Rhesus-negative women (0-2000) actually identified during the study. | 12 months | |
Secondary | Proportion of lady health visitors who will correctly perform point-of-care test and interpret the results of the point-of-care test | Ability of each lady health visitor to perform point-of-care test, each time a test is performed, a composite score (0-16) will be generated that takes into account all 16 steps of the standardized operational protocol. Composite test scores (0-16) will be plotted over time, where time will be evaluated in increments of days, weeks, and months. | 12 months | |
Secondary | Proportion of positive responses on knowledge pertaining to Rhesus disease in pregnant women and lady health visitors | Knowledge uptake will be assessed in both pregnant women and lady health visitors by comparing their baseline assessments with those completed at the close of the study (proportion of positive (i.e., Yes) responses). | 12 months | |
Secondary | Proportion of pregnant women who will accept RhIg prophylaxis | Acceptability of RhIg prophylaxis will be represented as the proportion of positive (i.e., Yes) responses to each of the 6 questions listed below. The acceptability of RhIg prophylaxis between sites will be compared. Did the participant verbally agree to receive prophylaxis? Do you think that receiving prophylaxis may improve the health of your newborn? Do you think that receiving prophylaxis was safe? Did your family approve of you receiving prophylaxis? Would you recommend receiving prophylaxis to other Rhesus-negative mothers in the village? In future pregnancies, would you agree to receive more injections of RhIg prophylaxis? We will also report the proportion of participants who agreed to receive 1 and/or 2 doses of RhIg in total, and by site. |
12 months | |
Secondary | Rate of stillbirths and neonatal deaths per 1000 live births in this population with respect to cause and Rhesus-negativity | Rate of stillbirths and newborn deaths will be tracked throughout the study and rates will be presented per 1000 live births. Finally, we will also report mean and median antibody titers for all Rhesus-negative women who have a miscarriage, stillbirth, or their newborns die within the first month of life. | 13 months |