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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00305253
• Collaborator: MacArthur Foundation (Other)
• Enrollment: 990
• Locations: 2
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 495
• Patients Per Site Per Month: 19

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemic Shock; Hemorrhage	Device: Non-pneumatic Anti-shock Garment (NASG)	Phase 1/Phase 2

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 990 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Pre-Intervention The Pre-Intervention Phase served as the Control / Baseline group.
Experimental: Post-Intervention Intervention used in this phase and outcomes compared to the Pre-Intervention phase.	Device: Non-pneumatic Anti-shock Garment (NASG); 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

Outcome Measures

Primary Outcome Measures

1. Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction) [from early pregnancy to within 3 weeks postpartum]

Secondary Outcome Measures

1. Blood Loss Due to Obstetric Hemorrhage [within 72 hours of study enrollment]

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

2. Emergency Hysterectomy [within 72 hours of study enrollment]

   incidence of emergency hysterectomy for cases of uterine atony

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assuit University Hospital	Assiut		Egypt
2	El-Galaa Teaching Hospital	Cairo		Egypt

Sponsors and Collaborators

• University of California, San Francisco
• MacArthur Foundation

Investigators

• Principal Investigator: Suellen Miller, CNM, PhD, RN, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Information and updates on current trials using the Life Wrap (NASG) for obstetric hemorrhage in low resource settings.

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00305253
• Other Study ID Numbers: 05-84956-000-GSS
• First Posted: Mar 21, 2006
• Last Update Posted: May 14, 2013
• Last Verified: May 1, 2013

• Keywords provided by University of California, San Francisco: maternal mortality; obstetric hemorrhage
• Additional relevant MeSH terms: Hemorrhage; Shock; Hypovolemia

Study Results

Participant Flow

Arm/Group Title	Pre-Intervention	Post-Intervention
Arm/Group Description	Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.	Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
Period Title: Overall Study
STARTED	432	559
COMPLETED	432	558
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Pre-Intervention	Post-Intervention	Total
Arm/Group Description	facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.	Total of all reporting groups
Overall Participants	432	558	990
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.7 (6.2)	28.9 (6.0)	28.8 (6.2)
Sex: Female, Male (Count of Participants)
Female	432 100%	558 100%	990 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Egypt	432 100%	558 100%	990 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study were used in this analysis.

Arm/Group Title	Pre-Intervention	Post-Intervention
Arm/Group Description	facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Measure Participants	432	558
Number [participants]	27 6.3%	11 2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pre-Intervention, Post-Intervention
	Comments	Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity. To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Regression, Logistic
	Comments	Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.

2. Secondary Outcome

Title	Blood Loss Due to Obstetric Hemorrhage
Description	cumulative blood loss measured hourly upon study admission by calibrated blood collection drape
Time Frame	within 72 hours of study enrollment

Outcome Measure Data

Analysis Population Description

Blood loss information was missing on some patients.

Arm/Group Title	Pre-Intervention	Post-Intervention
Arm/Group Description	facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Measure Participants	336	435
Mean (Standard Deviation) [mL]	378.9 (234.3)	253.2 (205.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pre-Intervention, Post-Intervention
	Comments	Mean measured volume of blood loss in the drape was compared across phases with t-tests.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.79
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.

3. Secondary Outcome

Title	Emergency Hysterectomy
Description	incidence of emergency hysterectomy for cases of uterine atony
Time Frame	within 72 hours of study enrollment

Outcome Measure Data

Analysis Population Description

Data on emergency hysterectomy are only for women with diagnosis of uterine atony.

Arm/Group Title	Pre-Intervention	Post-Intervention
Arm/Group Description	facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Measure Participants	278	396
Number [participants]	35 8.1%	28 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pre-Intervention, Post-Intervention
	Comments	Relative risks and confidence intervals were computed for emergency hysterectomy.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.

Adverse Events

Arm/Group Title	Pre-Intervention		Post-Intervention
Arm/Group Description	facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.		facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
All Cause Mortality
	Pre-Intervention		Post-Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-Intervention		Post-Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/432 (2.3%)		6/558 (1.1%)
Pregnancy, puerperium and perinatal conditions
Mortality	10/432 (2.3%)	10	6/558 (1.1%)	6
Other (Not Including Serious) Adverse Events
	Pre-Intervention		Post-Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/432 (3.9%)		5/558 (0.9%)
Cardiac disorders
Cardiac Failure	1/432 (0.2%)	1	0/558 (0%)	0
Nervous system disorders
Cerebral Impairment	2/432 (0.5%)	2	2/558 (0.4%)	2
Renal and urinary disorders
Renal Failure	14/432 (3.2%)	14	3/558 (0.5%)	3
Respiratory, thoracic and mediastinal disorders
Acute Respitory Distress Syndrome (ARDS)	3/432 (0.7%)	3	0/558 (0%)	0

Limitations/Caveats

Non-randomized, non-blinded pre-intervention/intervention design

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Local PIs are required to review results with Dr. Miller before releasing.