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Completed

NCT Number: NCT00305253

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

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.

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Key information

Conditions

Hypovolemic Shock Death Hemorrhage Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assuit University Hospital, Asyut, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: NASG, Manufactured by Zoex, Anti-Shock Garment, Life Wrap

Primary outcomes

  1. 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

  1. Blood Loss Due to Obstetric Hemorrhage

    Time frame: within 72 hours of study enrollment

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

  2. Emergency Hysterectomy

    Time frame: within 72 hours of study enrollment

    incidence of emergency hysterectomy for cases of uterine atony

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • MacArthur Foundation

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2006
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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