NASG: Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00488462

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Bill and Melinda Gates Foundation (Other), University of Zambia (Other), University of Zimbabwe (Other), World Health Organization (Other)

887

Enrollment

Locations

Arms

Duration (Months)

177.4

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemic Shock Hemorrhage	Device: non-pneumatic anti-shock garment	N/A

Detailed Description

This study is a cluster randomized controlled trial to examine the effects of NASG application as a first-aid device at the SHFs before transfer to Referral Hospitals (RHs).

The first step will include start-up activities and formative data collection, including facility staff training in data collection, how to collect blood in the closed-end blood collection drape, and in an evidence-based standardized clinical protocol for obstetric hemorrhage prevention and hemorrhage and shock management. Next will be a period of baseline data collection at the RHs and SHFs, during which clinical and demographic data will be collected from women diagnosed with obstetric hemorrhage and shock. After this baseline data collection period, we will introduce the study intervention, initially at the RHs and then at SHFs.

The intervention will include: review of study protocol differences between baseline and the NASG-intervention phases, provision of the NASG, detailed training on the use of NASG for health care providers and staff, as well as on-site support and supervision for use of the NASG. After the RH providers are fully trained and have become proficient in NASG use, SHFs will be randomized into 19 intervention and 19 control facilities. Intervention SHFs will receive the NASG training described above, while control SHFs will receive a refresher training on the topics included in the baseline training.

The final step will be three years of NASG-intervention data collection at the RHs and the SHFs on women diagnosed with obstetric hemorrhage and shock on the same outcomes collected in the baseline period. A total of approximately 2,340 women from the SHFs will be included in the NASG-intervention data collection phase of the cluster randomized trial: 1,170 women in the intervention group and 1,170 women in the control group.

Study Design

Study Type:

Interventional

Actual Enrollment :

887 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the control arm, half of the study clinics will not use the NASG but the NASG will be available at the referral hospital for patients transported there.
Other: Intervention Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the intervention arm, half of the study clinics will use the NASG on patients before transporting to the referral hospital.	Device: non-pneumatic anti-shock garment In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria. Other Names: NASG Anti-Shock Garment Manufactured by Zoex Life Wrap

Arm

Intervention/Treatment

No Intervention: Control

Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the control arm, half of the study clinics will not use the NASG but the NASG will be available at the referral hospital for patients transported there.

Other: Intervention

Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the intervention arm, half of the study clinics will use the NASG on patients before transporting to the referral hospital.

Device: non-pneumatic anti-shock garment

In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.

Other Names:

NASG

Anti-Shock Garment

Manufactured by Zoex

Life Wrap

Outcome Measures

Primary Outcome Measures

Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes [during hospital stay]

Secondary Outcome Measures

Mean amount of blood loss in mL , frequency of emergency hysterectomy, time to recovery from shock. [during hospital stay]
Blood loss as measured by the blood collection drape at the RH or pad between SHF and RH.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

To participate in these study activities, women must be willing and able to participate, be able to sign or mark a consent form, and speak one of the languages into which the consent form has been translated, including English, Nyanja, and Bemba in Zambia, and English, Shona and Ndebele in Zimbabwe.

Inclusion Criteria:

Women who are pregnant or postpartum and experiencing obstetric hemorrhage with 2 of the following 3:

blood loss > 500 mL (at SHF, 1000 mL at RH) SBP <100 mm Hg pulse >100 bpm

Exclusion Criteria:

Absolute exclusion criteria include: current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins and/or current bleeding sites above the diaphragm. Relative exclusion criteria include: a history or current clinical evidence of mitral stenosis or congestive heart failure (CHF). These must be relative contraindications that will be assessed at the time of hemorrhage and clinical judgment will need to be utilized to evaluate each case individually. Thus if the patient can be transported and delivered rapidly and is suspected or known to have valvular heart disease, she will be excluded from the study. In other cases, depending on the severity of the hemorrhage, if the patient is dyspneic in the NASG, at the SHF level, the NASG will be loosened, if that does not result in relief, the NASG will be removed. If the patients at the RH have decreasing oxygen saturation levels as demonstrated by pulse oximeter, the NASG will be loosened, if that does not result in relief, the NASG will be removed.

Women suffering obstetric hemorrhage and hypovolemic shock who have no detectable vital signs (non palpable pulse and BP) at the time of their arrival at the RH are ineligible for enrolment in the study ("non-resuscitable") if: 1) the woman does not respond to resuscitation attempts after 30 minutes and 2) more than three hours have elapsed between the start of hemorrhage and the beginning of her treatment. (As this is a clinical intervention of a potentially life saving device, the study clinicians should try the NASG on any patient if they feel it may resuscitate her; however, if the woman meets the criteria above they are ineligible for having their data entered into the study.)

Contacts and Locations

Locations

	Site	City	State	Country
1	Kitwe Central Hospital	Kitwe	Copperbelt	Zambia
2	Ndola Central Hospital	Ndola	Copperbelt	Zambia
3	University Teaching Hospital (UTH)	Lusaka		Zambia
4	Harare Hospital	Harare		Zimbabwe
5	Parienyatwa Group of Hospitals	Harare		Zimbabwe

Sponsors and Collaborators

University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bill and Melinda Gates Foundation
University of Zambia
University of Zimbabwe
World Health Organization

Investigators

Principal Investigator: Suellen Miller, CNM, PhD, University of California, San Francisco
Study Director: Elizabeth Butrick, MPH, MSW, University of California, San Francisco
Principal Investigator: Thulani Magwali, OBGYN, University of Zimbabwe Hospital, Harare, Zimbabwe (UZ)
Principal Investigator: Gricelia Mkumba, OBGYN, University Teaching Hospital, Lusaka Zambia (UTH)