DOI: 10.7272/q6ms3qnx
title: Shock Index for Predicting Adverse Obstetric Hemorrhage Outcome

description: This dataset includes clinical data for 958 women comprising
 pre-intervention/control participants from four studies conducted by the
 Safe Motherhood Program at the University of California, San Francisco
 that evaluated the effectiveness of the non-pneumatic anti-shock garment
 (NASG) to reduce adverse maternal outcomes for women with hypovolemic
 shock secondary to severe obstetric hemorrhage: Egypt 2004 (n=158), Egypt
 2006-2008 (n=430), Nigeria 2004-2007 (n=179) and Zambia and Zimbabwe
 2007-2012 (n=191) and were not missing data on vital signs or death. Three
 of these studies, based at the tertiary level, followed a
 quasi-experimental design where a pre-intervention period was temporally
 followed by an NASG intervention period, and one was a cluster-randomized
 control trial (CRCT) of NASG application at the primary health clinic
 (PHC) level, prior to transport to tertiary facility for definitive
 treatment. The pre-intervention/control participants in all studies
 received standardized evidence-based hemorrhage and shock management.
 Women in all trials were eligible for study participation if they reached
 a threshold estimated blood loss and one or more of the following: SBP
 &lt; 100 mm Hg and/or pulse &gt; 100 BPM. In the tertiary facility
 studies in Egypt and Nigeria, the threshold estimated blood loss was
 &gt;750ml, while in the Zambia and Zimbabwe PHC-enrolled study the
 threshold EBL was &gt;500 mL. The majority of facilities were
 under-staffed, under-resourced, and characterized by long delays in
 obtaining definitive care (surgery, blood transfusions). Initial study
 protocols, including informed consent procedures, were approved by
 institutional review boards at the University of California, San
 Francisco, and for each study, respectively, by the following
 institutions: University of Zambia, Lusaka Research Ethics Committee;
 Medical Research Council of Zimbabwe; Department of Reproductive Health
 and Research of the World Health Organization Ethics Review Committee;
 National Reproductive Health Research Committee of the Nigerian Federal
 Ministry of Health, El Galaa Maternity Teaching Hospital; Assiut
 University Women’s Health Center; Alexandria University Teaching Hospital;
 and Al Minya University Teaching Hospital. All women provided written or
 thumbprint (if illiterate) informed consent for study participation; all
 ethics committees provided a waiver of consent from women who were
 unconscious or confused at time of admission until they recovered or
 written consent was obtained from a relative as proxy.
description: Data captured included participant vital sign values at the
 measurement interval with the highest shock index (pulse/SBP) within the
 first hour after study entry: pulse, systolic blood pressure, diastolic
 blood pressure, mean arterial pressure (MAP= (2 x DBP + SBP)/3), SI
 (pulse/SBP), and pulse pressure (SBP-DBP). Severe shock at study entry was
 defined as MAP less than 60 mmHg, below which perfusion of vital organs
 has been proposed to be inadequate. BP was measured via an automated blood
 pressure device or auscultatory technique with mercury sphygmomanometer.
 Outcomes comprised any severe adverse maternal event related to obstetric
 hemorrhage, and included organ system dysfunction-based criteria and
 intervention-based criteria. Although the outcomes for the original trials
 were determined prior to the development of the WHO “Near-Miss” criteria,
 they are very similar. The original outcomes for the studies were maternal
 mortality; end-organ system failure morbidity defined as
 clinically-diagnosed major organ failure (respiratory, renal,
 neurological, cardiac) lasting for 24 hours post-resuscitation; and the
 intervention variables ICU admission, blood transfusion, and emergency
 hysterectomy for intractable uterine atony. These outcomes were selected
 because in the majority of our study sites, laboratory-based criteria
 (e.g., determining DIC by platelets), were not consistently available. For
 the purposes of the present analysis we used the WHO maternal near-miss
 indicators for our outcomes. We evaluated maternal status as 1) death or
 2) severe maternal outcome (SMO), a composite indicator of death or severe
 end-organ failure maternal morbidity. Finally we combined SMO with the WHO
 intervention-based near-miss criteria ICU admission, blood transfusion ≥5
 units and emergency hysterectomy (uterine atony diagnoses only). WHO
 labels these as “critical interventions”; therefore, to be consistent with
 WHO criteria, we called our composite indicator of SMO and the critical
 interventions SMO-CI.