Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

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Abstract

OBJECTIVE:

To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)–cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management.

METHODS:

Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success, defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony).

RESULTS:

In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported.

CONCLUSION:

For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT04995887.

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Most cited references 17

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Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

, Haleema Shakur, Ian Roberts … (2017)

Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.

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Practice Bulletin No. 183

(2017)

Maternal hemorrhage, defined as a cumulative blood loss of greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process, remains the leading cause of maternal mortality worldwide (1). Additional important secondary sequelae from hemorrhage exist and include adult respiratory distress syndrome, shock, disseminated intravascular coagulation, acute renal failure, loss of fertility, and pituitary necrosis (Sheehan syndrome).Hemorrhage that leads to blood transfusion is the leading cause of severe maternal morbidity in the United States closely followed by disseminated intravascular coagulation (2). In the United States, the rate of postpartum hemorrhage increased 26% between 1994 and 2006 primarily because of increased rates of atony (3). In contrast, maternal mortality from postpartum obstetric hemorrhage has decreased since the late 1980s and accounted for slightly more than 10% of maternal mortalities (approximately 1.7 deaths per 100,000 live births) in 2009 (2, 4). This observed decrease in mortality is associated with increasing rates of transfusion and peripartum hysterectomy (2-4).The purpose of this Practice Bulletin is to discuss the risk factors for postpartum hemorrhage as well as its evaluation, prevention, and management. In addition, this document will encourage obstetrician-gynecologists and other obstetric care providers to play key roles in implementing standardized bundles of care (eg, policies, guidelines, and algorithms) for the management of postpartum hemorrhage.

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Severe Maternal Morbidity Among Delivery and Postpartum Hospitalizations in the United States

William Callaghan, Andreea A. Creanga, Elena V. Kuklina (2012)

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Author and article information

Journal

Title: Obstetrics & Gynecology

Publisher: Ovid Technologies (Wolters Kluwer Health)

ISSN (Print): 0029-7844

Publication date Created: 2023

Publication date (Print): September 14 2023

Article

DOI: 10.1097/AOG.0000000000005366

PubMed ID: 37713322

SO-VID: 39d9774a-7e31-472c-a3a6-59407fd1d82e

License:

http://creativecommons.org/licenses/by-nc-nd/4.0/

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