The Prevention of Rh Disease of Newborns in Pakistan

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 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.

Conditions

• Rhesus Disease
• Anti-D (Rh) Antibodies Affecting Care of Mother

Interventions

DRUG

RhIg prophylaxis

Two RhIg prophylaxis injections for Rh negative women

DEVICE

ELDONCARD

ELDONCARD point-of-care test.

DIAGNOSTIC_TEST

ELDONCARD Test

LHVs will perform ELDONCARD test.

Sponsors & Collaborators

• The Hospital for Sick Children

  collaborator OTHER

• Grand Challenges Canada

  collaborator OTHER

• Aga Khan University

  lead OTHER

Principal Investigators

• Sajid B Soofi, FCPS · Aga Khan University

• Gul N Khan, MPH · Aga Khan University

• Shaun Morris, MPH · Hospital for Sick-kids Canada

• Shabina Ariff, FCPS · Aga Khan University

• Sidrah Nausheen, FCPS · Aga Khan University

• Lisa Pell, PhD · Hospital for Sick-kids Canada

• Alvin Zipursky, MD · Eldon Biologicals A/S

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-27

Primary Completion

2019-12-31

Completion

2020-02-28

FDA Drug

Yes

FDA Device

Yes

Countries

• Pakistan

Study Locations