The global burden of disease from maternal morbidity and mortality is great. Pregnancy and childbirth related illnesses are the second leading cause of lost years of healthy life among women of reproductive, age in developing countries, accounting for nearly 31 million disability adjusted life years (DALYS) lost annually. The largest contributor to maternal death and disability is obstetric hemorrhage. Due to long delays in obtaining definitive therapy, such as blood transfusion or surgery, women bleed to death at home, in primary health care centers, and on the road to referral hospitals. The goal of this proposed study is to reduce maternal mortality and severe morbidities from obstetric hemorrhage and hypovolemic shock by the first-aid application of the non-pneumatic anti-shock garment (NASG). The NASG is a reusable neoprene and Velcro lower-body compression suit, which has, outside of a few pilot trials, never been used in the developing world. Although it has been shown to reverse shock and to decrease blood loss in obstetric patients in one pre/post pilot study in Egypt, there is, currently, no evidence that its use will decrease maternal mortality or morbidity. In an era of evidence-based practice, maternity health care systems in low resource settings cannot adopt new procedures without approval of international donors and health experts. The primary aim of this study is to demonstrate, using a cluster-randomized controlled design, that application of the NASG at the primary health care level before transfer to a referral hospital will decrease extreme adverse outcomes, i.e., maternal mortality and severe maternal morbidity. The primary aim of this project is to test the effectiveness of the NASG as first aid hemorrhage and shock management to) 1) reduce the incidence of maternal mortality, 2) reduce the incidence of severe acute maternal morbidity, 3) reduce the incidence of emergency hysterectomies, and 4) reduce the time to recovery from hemorrhagic shock. The secondary aim is to examine negative effects that might be associated with NASG use, including 1) decreased urine output, 2) hypoxia, dyspnea, or other forms of respiratory distress, 3) increased intraoperative bleeding, and/or 4) nausea and vomiting in the women who receive the NASG.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD053129-05
Application #
8094335
Study Section
Nursing Science: Children and Families Study Section (NSCF)
Program Officer
Reddy, Uma M
Project Start
2007-06-01
Project End
2013-05-31
Budget Start
2011-06-01
Budget End
2013-05-31
Support Year
5
Fiscal Year
2011
Total Cost
$418,744
Indirect Cost
Name
University of California San Francisco
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
El Ayadi, Alison M; Nathan, Hannah L; Seed, Paul T et al. (2016) Vital Sign Prediction of Adverse Maternal Outcomes in Women with Hypovolemic Shock: The Role of Shock Index. PLoS One 11:e0148729
Butrick, Elizabeth; Penn, Amy; Itakura, Kaoru et al. (2014) Access to transport for women with hypovolemic shock differs according to weeks of pregnancy. Int J Gynaecol Obstet 127:171-4
El Ayadi, Alison; Gibbons, Luz; Bergel, Eduardo et al. (2014) Per-protocol effect of earlier non-pneumatic anti-shock garment application for obstetric hemorrhage. Int J Gynaecol Obstet 126:95-6
Miller, Suellen; Bergel, Eduardo F; El Ayadi, Alison M et al. (2013) Non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: a cluster randomized trial. PLoS One 8:e76477