Clinical trials: PPH - Postpartum Hemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
Postpartum Haemorrhage (PPH)
Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
The purpose of this study is to evaluate whether a medical device called the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) can safely and effectively temporarily stop severe bleeding after childbirth (known as…
- Trial name
- TAOAT (NCT07016568)
- Testing
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Where
- Ukraine
- Volunteers
- 4 people
- Sponsor
- LLC UkrMedGroup
Postpartum Hemorrhage
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.
- Trial name
- PEARLE (NCT02883673)
- Testing
- Jada System
- Where
- 15 sites in United States
- Volunteers
- 107 people
- Sponsor
- Alydia Health
Postpartum Haemorrhage
Treatment of Women After Postpartum Haemorrhage
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
- Trial name
- PP-01 (NCT01895218)
- Testing
- Iron isomaltoside 1000, Standard medical Care
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Pharmacosmos A/S
Postpartum Hemorrhage, Immediate Postpartum Hemorrhage
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.
- Conditions
- Postpartum Hemorrhage, Immediate Postpartum Hemorrhage, Hemorrhage, Postpartum
- Trial name
- SERENE (NCT06452355)
- Testing
- KOKO Device
- Where
- 17 sites in United States
- Volunteers
- 73 people
- Sponsor
- KOKO Medical Inc.
Severe Postpartum Haemorrhage
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not…
- Trial name
- NCT04444856
- Testing
- Eptacog alfa (activated), Standard of care
- Where
- Switzerland
- Volunteers
- 225 people
- Sponsor
- Novo Nordisk A/S
Cesarean Section Complications, Post Partum Hemorrhage
DAISY Uterine Drain Device Evaluation
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as…
- Conditions
- Cesarean Section Complications, Post Partum Hemorrhage, Uterine Atony With Hemorrhage, Uterine Bleeding
- Trial name
- NCT06219538
- Testing
- DAISY Uterine Drain
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Severe Postpartum Haemorrhage
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth.
- Trial name
- NCT07157423
- Testing
- Eptacog alfa (NovoSeven)
- Where
- 14 sites in India
- Volunteers
- 64 people
- Sponsor
- Novo Nordisk A/S
Post-Partum Hemorrhage
Fibrinogen in Haemorrhage of Delivery
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of…
- Trial name
- FIDEL (NCT02155725)
- Testing
- Human Fibrinogen concentrate
- Where
- 31 sites in France, Martinique
- Volunteers
- 448 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Blood Loss Massive, Trauma
QStat in Trauma and Obstetric Hemorrhage
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum hemorrhage.
- Conditions
- Blood Loss Massive, Trauma, Post Partum Hemorrhage
- Trial name
- NCT04385953
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- HemoSonics LLC
Severe Postpartum Haemorrhage
Treatment of Women After Severe Postpartum Haemorrhage
The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
- Trial name
- PP-02 (NCT01895205)
- Testing
- Iron isomaltoside 1000, Red blood cell transfusion
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Pharmacosmos A/S
Postpartum Hemorrhage
Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
This multicenter study aims to evaluate effectiveness and safety of using the AAJT-S device as a temporary intervention for severe, atony-related PPH that is refractory to standard therapies
- Trial name
- ACT-PPH (NCT07034924)
- Testing
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Where
- Ukraine
- Volunteers
- 20 people
- Sponsor
- LLC UkrMedGroup
Post Partum Hemorrhage
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant…
- Trial name
- NCT06968481
- Testing
- Oxytocin sublingual, Oxytocin IM
- Where
- Nigeria
- Volunteers
- 330 people
- Sponsor
- Insud Pharma
Postpartum Hemorrhage
RUBY Post-Market Registry on the Jada® System
The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.
- Trial name
- RUBY (NCT04995887)
- Testing
- Jada® System
- Where
- 16 sites in United States
- Volunteers
- 809 people
- Sponsor
- Alydia Health
Postpartum Hemorrhage
Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers
Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum haemorrhage (PPH). However, in resource-poor settings within the developing world, the stability and therefore effectiveness of prophylactic IM…
- Trial name
- NCT02542813
- Testing
- IM oxytocin 10 IU, IH oxytocin 50 mcg, IH oxytocin 200 mcg
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hemorrhage, Gastrointestinal Hemorrhage
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works…
- Conditions
- Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage
- Trial name
- HEAL (NCT07753005)
- Testing
- Embolization therapy
- Where
- 11 sites in Japan
- Volunteers
- 176 people
- Sponsor
- Aesculap AG
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Postpartum Hemorrhage
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage…
- Trial name
- NCT06033170
- Testing
- CELOX™ PPH
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Medtrade
Postpartum Hemorrhage
Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings.
- Trial name
- NCT02999100
- Testing
- IH Oxytocin, IM Oxytocin, IV Oxytocin
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Blood Loss Massive, Trauma
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients or patients with OB hemorrhage.
- Conditions
- Blood Loss Massive, Trauma, Hemorrhage, Postpartum
- Trial name
- NCT03912545
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC