Status:
COMPLETED
The Prevention of Rh Disease of Newborns in Pakistan
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
The Hospital for Sick Children
Grand Challenges Canada
Conditions:
Rhesus Disease
Anti-D (Rh) Antibodies Affecting Care of Mother
Eligibility:
FEMALE
15-49 years
Brief Summary
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) ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
1654 Patients enrolled
Trial Details
Trial ID
NCT03297671
Start Date
June 27 2018
End Date
February 28 2020
Last Update
July 9 2020
Active Locations (1)
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1
Taluka Headquarter Hospital Johi and District Headquarter Hospital Dadu
Goth Dado, Sindh, Pakistan, 74800