Trial reportObstetrics and gynecology2020
Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.
Trial report in Obstetrics and gynecology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
Clinical Trial Designed to Assess the Safety and Effectiveness of the KOKO™ Device In Treating Primary Abnormal Postpartum Uterine Bleeding ("APUB") or Hemorrhage ("PPH")
Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.
Who cites it
22 citing papers in PubMed, 74 citations in OpenAlex.
- Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Trial
- Vacuum-assisted hemorrhage control device versus uterine balloon tamponade for refractory atonic postpartum hemorrhage in a protocol-driven care pathway-A retrospective cohort study.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Postpartum Hemorrhage: A Comprehensive Review of Medical and Surgical Treatment.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2026Review
- Management of obstetric and gynecologic hemorrhage: a narrative review of current guidelines and evidence.Journal of medicine and life · 2026Review
- Predicting intrauterine vacuum-induced postpartum hemorrhage-control device treatment success.Pregnancy (Hoboken, N.J.) · 2026Article
- Article
- Beyond Standard Algorithms: Diagnostic, Procedural, and Analgesic Challenges in Refractory Postpartum Hemorrhage.Cureus · 2026Article
- Article
- Intrauterine, Vacuum-Induced, Hemorrhage-Control Device System Contributing to Blood Loss in Fulminant DIC.Case reports in obstetrics and gynecology · 2025Article
- Postpartum Hemorrhage.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2025Review
- Review
- Global research priorities for intrauterine suction and sponge tools for postpartum haemorrhage management in low-income and middle-income countries: a modified Delphi approach.BMJ public health · 2024Article
- Intrauterine vacuum-induced hemorrhage-control device for hemorrhage after myomectomy: a case report and review of the literature.Gynecology and pelvic medicine · 2024Article
- Peripartum Haemorrhage, Diagnosis and Therapy. Guideline of the DGGG, OEGGG and SGGG (S2k, AWMF Registry No. 015-063, August 2022).Geburtshilfe und Frauenheilkunde · 2023Article
- Development and evaluation of a wearable peripheral vascular compensation sensor in a swine model of hemorrhage.Biomedical optics express · 2023Article
- Performance of Bakri balloon tamponade in controlling postpartum hemorrhage.American journal of translational research · 2023Article
- Review of Current Insights and Therapeutic Approaches for the Treatment of Refractory Postpartum Hemorrhage.International journal of women's health · 2023Review
- Obstetric Disorders and Critical Illness.Clinics in chest medicine · 2022Review
- [Postpartum hemorrhage : Interdisciplinary consideration in the context of patient blood management].Der Anaesthesist · 2022Review
- Effect of Mirena Intrauterine Device on Endometrial Thickness, Quality of Life Score, and Curative Effect in Patients with Perimenopausal Abnormal Uterine Bleeding.Computational and mathematical methods in medicine · 2022Article
Corrections and comments
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Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.
methodsA multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device.
resultsOf 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%).
conclusionIntrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL
trial registrationClinicalTrials.gov, NCT02883673.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.