Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

University of California, San Francisco990 enrolled

Overview

This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG.

This is a comparative, pre-post study of the Non-pneumatic Anti-Shock Garment (NASG) to establish its effectiveness in reducing maternal mortality and morbidity due to obstetrical hemorrhage. The sites are two maternity teaching hospitals in Egypt: El Galaa, in Cairo and Assiut University in Assiut. Our main aim was to test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG. Our primary outcome was Extreme Adverse Outcomes (EAO) - a combined outcome of maternal mortality and severe morbidity. Secondary outcomes included mean measured blood loss and incidence of emergency hysterectomy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

990

Conditions

Hypovolemic Shock Hemorrhage

Interventions

Non-pneumatic Anti-shock Garment (NASG)DEVICE

In the Post-Intrevention phase of the study, the NASG will be used when a patient meets the study criteria.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * blood loss from obstetric hemorrhage \>= 1000 mL * pulse \> 100 beats per minute or systolic blood pressure \< 100 mmHg Exclusion Criteria: Absolute exclusion criteria: * current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins * current bleeding sites above the diaphragm. Relative exclusion criteria: * history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)

Locations (2)

Assuit University Hospital

Asyut, Egypt

El-Galaa Teaching Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)

Time frame: from early pregnancy to within 3 weeks postpartum

Secondary Outcomes

Blood Loss Due to Obstetric Hemorrhage

cumulative blood loss measured hourly upon study admission by calibrated blood collection drape

Time frame: within 72 hours of study enrollment

Emergency Hysterectomy

incidence of emergency hysterectomy for cases of uterine atony

Time frame: within 72 hours of study enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.