Rhesus DiseaseNCT03297671
The Prevention of Rh Disease of Newborns in Pakistan
An observational study of Rhesus Disease and Anti-D (Rh) Antibodies Affecting Care of Mother, run by Aga Khan University at 1 site in Pakistan.
Trial 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) acceptance by pregnant women to receive the point-of-care test; and, 2) ability of health workers to administer the… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Rhesus Disease, Anti-D (Rh) Antibodies Affecting Care of Mother
- What is being tested?
- RhIg prophylaxis, ELDONCARD and ELDONCARD Test
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 1,654 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jun 2018to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Child, Adult
Study population: Study population will be LHVs, pregnant women and non-study health care professional
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 13Show fewer
- Does not provide written consent
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Taluka Headquarter Hospital Johi and District Headquarter Hospital Dadu
Goth Dado, Sindh, 74800
About this study
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.
Read the 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. 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.
- Being tested
- RhIg prophylaxis, ELDONCARD, ELDONCARD Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhIg prophylaxisDrug
Also called Training on Rh disease
Two RhIg prophylaxis injections for Rh negative women
ELDONCARDDevice
ELDONCARD point-of-care test.
ELDONCARD TestDiagnostic test
LHVs will perform ELDONCARD test.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | 2000 pregnant women from the communities in the catchment area of THQ Johi and DHQ Dadu. Rh negative women will receive two RhIg prophylaxis injections. Receives: Drug: RhIg prophylaxis; Device: ELDONCARD; Diagnostic Test: ELDONCARD Test | |
| Lady Health Visitors (LHVs) | 3-5 LHVs who are full time employees at THQ Johi and DHQ Dadu. LHVs will perform ELDONCARD test and provide RhIg prophylaxis injections. Receives: Drug: RhIg prophylaxis; Device: ELDONCARD; Diagnostic Test: ELDONCARD Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start27 Jun 2018
- Primary completion31 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rhesus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid B Soofi, FCPS, Principal investigator, Aga Khan UniversityGul N Khan, MPH, Study director, Aga Khan UniversityShaun Morris, MPH, Principal investigator, Hospital for Sick-kids CanadaShabina Ariff, FCPS, Principal investigator, Aga Khan UniversitySidrah Nausheen, FCPS, Principal investigator, Aga Khan UniversityLisa Pell, PhD, Principal investigator, Hospital for Sick-kids CanadaAlvin Zipursky, MD, Principal investigator, Eldon Biologicals A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297671
- Sponsor's protocol ID
- Rh Study
- Status last verified
- Jul 2020
- First submitted
- 26 Sep 2017
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
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.
PubMed 25582277Fung 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, Desilets VA, Summers A, Wyatt P, Young DC; Maternal-Fetal Medicine Committee, Genetics Committee. Prevention of Rh alloimmunization. J Obstet Gynaecol Can. 2003 Sep;25(9):765-73. doi: 10.1016/s1701-2163(16)31006-4.
PubMed 12970812ELDON K. Simultaneous ABO and Rh groupings on cards in the laboratory or at the bedside. Dan Med Bull. 1955 Mar;2(2):33-40. No abstract available.
PubMed 14379729Biologicals, E. Clinical Evidence - Comparative Study of EldonCards. 2012
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. No abstract available.
PubMed 21037283World Health Organization, U., Handbook IMCI. Integrated Management of Childhood Illness. 2005.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03297671
- Acronym / sponsor ID
- Rh Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,654 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Drug: RhIg prophylaxis, Device: ELDONCARD, Diagnostic Test: ELDONCARD Test2000 pregnant women from the communities in the catchment area of THQ Johi and DHQ Dadu. Rh negative women will receive two RhIg prophylaxis injections. |
| Lady Health Visitors (LHVs) | – | Drug: RhIg prophylaxis, Device: ELDONCARD, Diagnostic Test: ELDONCARD Test3-5 LHVs who are full time employees at THQ Johi and DHQ Dadu. LHVs will perform ELDONCARD test and provide RhIg prophylaxis injections. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Study population will be LHVs, pregnant women and non-study health care professional
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhIg prophylaxisAlso: Training on Rh diseaseTwo RhIg prophylaxis injections for Rh negative women | Drug | Lady Health Visitors (LHVs), Pregnant Women |
| ELDONCARDELDONCARD point-of-care test. | Device | Lady Health Visitors (LHVs), Pregnant Women |
| ELDONCARD TestLHVs will perform ELDONCARD test. | Diagnostic test | Lady Health Visitors (LHVs), Pregnant Women |
Primary outcome
Proportion of pregnant women who will accept the point of care ELDONCARD test
Time frame: 12 months
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. 1. Did the participant agree to have the point-of-care test? 2. Do you think that having the point-of-care test will provide information that could improve the health of your newborn? 3. Do you think the point-of-care test was safe? 4. Did your family approve of you having the point-of-care test? 5. Would you recommend the point of care test to other mothers in the village? 6. In the future, would you agree to have this point of care test again?
5 secondary outcomes
Prevalence of Rhesus negativity in pregnant women
Time frame: 12 months
Proportion of lady health visitors who will correctly perform point-of-care test and interpret the results of the point-of-care test
Time frame: 12 months
Proportion of positive responses on knowledge pertaining to Rhesus disease in pregnant women and lady health visitors
Time frame: 12 months
Proportion of pregnant women who will accept RhIg prophylaxis
Time frame: 12 months
Rate of stillbirths and neonatal deaths per 1000 live births in this population with respect to cause and Rhesus-negativity
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Results publication: PubMed 25582277Zipursky 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.
- Results publication: PubMed 12970812Fung 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, Desilets VA, Summers A, Wyatt P, Young DC; Maternal-Fetal Medicine Committee, Genetics Committee. Prevention of Rh alloimmunization. J Obstet Gynaecol Can. 2003 Sep;25(9):765-73. doi: 10.1016/s1701-2163(16)31006-4.
- Results publication: PubMed 14379729ELDON K. Simultaneous ABO and Rh groupings on cards in the laboratory or at the bedside. Dan Med Bull. 1955 Mar;2(2):33-40. No abstract available.
- Results publicationBiologicals, E. Clinical Evidence - Comparative Study of EldonCards. 2012
- Results publication: PubMed 21037283Zipursky 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. No abstract available.
- Results publicationWorld Health Organization, U., Handbook IMCI. Integrated Management of Childhood Illness. 2005.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
Related trials for Rhesus Disease
RecruitingPhase 2
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
Hemolytic Disease of the Newborn, Fetal Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajid B Soofi, FCPS principal investigator
Aga Khan University
Gul N Khan, MPH study director
Aga Khan University
Shaun Morris, MPH principal investigator
Hospital for Sick-kids Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhesus Disease and Anti-D (Rh) Antibodies Affecting Care of Mother, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pregnant women who will accept the point of care ELDONCARD test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297671, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.