Trial Outcomes & Findings for Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt (NCT NCT00305253)

NCT ID: NCT00305253

Last Updated: 2013-05-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 990 participants
• Primary outcome timeframe: from early pregnancy to within 3 weeks postpartum
• Results posted on: 2013-05-14

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Pre-Intervention Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.	Post-Intervention Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pre-Intervention n=432 Participants facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=558 Participants facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.	Total n=990 Participants Total of all reporting groups
Age Continuous	28.7 years STANDARD_DEVIATION 6.2 • n=5 Participants	28.9 years STANDARD_DEVIATION 6.0 • n=7 Participants	28.8 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	432 Participants n=5 Participants	558 Participants n=7 Participants	990 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	432 participants n=5 Participants	558 participants n=7 Participants	990 participants n=5 Participants

PRIMARY outcome

Timeframe: from early pregnancy to within 3 weeks postpartum

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

Outcome measures

Measure	Pre-Intervention n=432 Participants facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=558 Participants facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)	27 participants	11 participants

SECONDARY outcome

Timeframe: within 72 hours of study enrollment

Population: Blood loss information was missing on some patients.

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

Outcome measures

Measure	Pre-Intervention n=336 Participants facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=435 Participants facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Blood Loss Due to Obstetric Hemorrhage	378.9 mL Standard Deviation 234.3	253.2 mL Standard Deviation 205.3

SECONDARY outcome

Timeframe: within 72 hours of study enrollment

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

incidence of emergency hysterectomy for cases of uterine atony

Outcome measures

Measure	Pre-Intervention n=278 Participants facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=396 Participants facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Emergency Hysterectomy	35 participants	28 participants

Adverse Events

Pre-Intervention

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Post-Intervention

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pre-Intervention n=432 participants at risk facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=558 participants at risk facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Pregnancy, puerperium and perinatal conditions Mortality	2.3% 10/432 • Number of events 10	1.1% 6/558 • Number of events 6

Other adverse events

Measure	Pre-Intervention n=432 participants at risk facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.	Post-Intervention n=558 participants at risk facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
Renal and urinary disorders Renal Failure	3.2% 14/432 • Number of events 14	0.54% 3/558 • Number of events 3
Respiratory, thoracic and mediastinal disorders Acute Respitory Distress Syndrome (ARDS)	0.69% 3/432 • Number of events 3	0.00% 0/558
Nervous system disorders Cerebral Impairment	0.46% 2/432 • Number of events 2	0.36% 2/558 • Number of events 2
Cardiac disorders Cardiac Failure	0.23% 1/432 • Number of events 1	0.00% 0/558

Additional Information

Suellen Miller

University of California San Francisco (UCSF)

Phone: 415 597 9394

Email: smiller@globalhealth.ucsf.edu , suellenmiller@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee Local PIs are required to review results with Dr. Miller before releasing.
• Publication restrictions are in place

Restriction type: OTHER