Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

Summary

This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.

Conditions

• Hypovolemic Shock
• Hemorrhage

Interventions

DEVICE

non-pneumatic anti-shock garment

In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• University of Zimbabwe

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Suellen Miller, CNM, PhD · University of California, San Francisco

• Elizabeth Butrick, MPH, MSW · University of California, San Francisco

• Thulani Magwali, OBGYN · University of Zimbabwe Hospital, Harare, Zimbabwe (UZ)

• Gricelia Mkumba, OBGYN · University Teaching Hospital, Lusaka Zambia (UTH)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2012-05-31

Completion

2012-05-31

Countries

• Zambia
• Zimbabwe

Study Locations