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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemorrhage, Hypovolemic Shock

Intervention / Treatment
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* Device: non-pneumatic anti-shock garment


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.<br>* Other names: Life Wrap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes |  | during hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of blood loss in mL , frequency of emergency hysterectomy, time to recovery from shock. | Blood loss as measured by the blood collection drape at the RH or pad between SHF and RH. | during hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstetric hemorrhage, hypovolemic shock, non-pneumatic anti-shock garment, safe motherhood, maternal mortality, maternal morbidity