Clinical trials: Postpartum Women
Severe Postpartum Depression
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum…
- Trial name
- NCT02614547
- Testing
- SAGE-547
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Mastitis, Breast Milk
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health
- Trial name
- NCT04032899
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- 3 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
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
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
Post Partum Haemorrhage
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.
- Trial name
- NCT02908126
- Testing
- Oxytocin
- Where
- Sweden
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Oxytone Bioscience BV
Migraine, Pregnancy Related
Safety of Nerivio in Pregnant Women With Migraine
This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum.
- Trial name
- NCT05464069
- Testing
- Nerivio, Migraine Relief
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Theranica
Blood Loss Massive, Post Partum Hemorrhage
QStat Cartridge in Obstetric Patients
This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.
- Trial name
- NCT06255496
- Testing
- Quantra Hemostasis Analyzer with the QStat Cartridge
- Where
- 6 sites in United States
- Volunteers
- 296 people
- Sponsor
- HemoSonics LLC
Postpartum Depression
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
- Trial name
- NCT05551195
- Testing
- WB001, ED001
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Woebot Health
Postpartum Depression
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States…
- Trial name
- NCT04273191
- Testing
- Brexanolone
- Sponsor
- Sage Therapeutics
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
Depression, Postpartum
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD.
- Trial name
- NCT07047820
- Testing
- Zuranolone
- Where
- United States
- Volunteers
- 305 people
- Sponsor
- Biogen
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 Depression
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known…
- Trial name
- NCT07398469
- Testing
- Zuranolone
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Biogen
Severe Postpartum Depression
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from…
- Trial name
- NCT06057012
- Testing
- BRII-296, Depo Medrol
- Where
- 11 sites in United States
- Volunteers
- 11 people
- Sponsor
- Brii Biosciences Limited
Postpartum Depression
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the…
- Trial name
- NCT02978326
- Testing
- SAGE-217 15/20 mg Oral Solution, SAGE 217 30 mg Capsules
- Where
- 27 sites in United States
- Volunteers
- 276 people
- Sponsor
- Biogen
Maternal Health
Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women
The goal of this RCT is to evaluate the effectiveness of Joyuus on improving maternal functioning with postpartum moms. The main questions it aims to answer are: The primary hypothesis is that participants of the Joyuus program…
- Trial name
- NCT05876559
- Testing
- Joyuus Self-care Mobile App, Standard Care
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Joyuus, LLC
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.
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