Clinical trials: Pregnancy Postpartum
Pregnancy; Fetomaternal Hemorrhage
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization.
- Trial name
- NCT01666249
- Testing
- Immunoglobulin Anti-RhD
- Where
- 5 sites in Brazil
- Volunteers
- 347 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil
Postpartum Depression (PPD)
SAINT in Postpartum Depression (PPD)
This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively…
- Trial name
- NCT07210255
- Testing
- SAINT Neuromodulation System
- Where
- 4 sites in United States
- Volunteers
- 192 people
- Sponsor
- Magnus Medical
Postpartum Depression
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum…
- Trial name
- NCT02942004
- Testing
- SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
- Where
- 32 sites in United States
- Volunteers
- 138 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
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
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
HIV, HIV Infections
A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125…
- Conditions
- HIV, HIV Infections, Pregnancy
- Trial name
- NCT00855335
- Testing
- Darunavir, Ritonavir, Etravirine
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 77 people
- Sponsor
- Janssen Scientific Affairs, LLC
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
COVID-19, Pregnant Women
Qatar PREgnancy Covid-19 OUtcome Study
The in-utero exposure of acute viral infection in some instances is proven to have short- and long-term neonatal effects during the postnatal and childhood period and the Zika virus, measles, mumps, and rubella are few examples.
- Trial name
- QPRECIOUS (NCT05349279)
- Where
- Qatar
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
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
Infectious Disease, Neoplasms
AnovaOS Network Powered Patient Registry
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and…
- Conditions
- Infectious Disease, Neoplasms, Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89), Endocrine, Nutritional and Metabolic Diseases (E00-E89)
- Trial name
- NCT05013944
- Where
- United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Anova Enterprises, Inc
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.
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.
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Depression, Postpartum
Type II Diabetes Mellitus in Patients Exposed to Pravastatin and Paroxetine
Type 2 Diabetes (T2DM) is a life-long, chronic condition affecting an individuals' ability to regulate glucose levels in the blood. Diabetes can cause many severe complications if not treated properly.
- Trial name
- NCT01602913
- Testing
- Pravastatin alone, Paroxetine alone, Pravastatin and paroxetine combined
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Pregnancy Related, Mental Health Issue
MamaConecta: Digital Tool for Maternal Mental Health
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period.
- Conditions
- Pregnancy Related, Mental Health Issue, Postpartum Depression, Postpartum Anxiety
- Trial name
- DDT (NCT06442774)
- Testing
- Mobile application, Monitoring via wearable
- Where
- 3 sites in Spain
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- A Thousand Colibris, S.L
Postpartum Depression
A Study of BRII-297 in Healthy Adult Subjects
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy adult subjects.
- Trial name
- NCT05845840
- Testing
- BRII-297
- Where
- Australia
- Volunteers
- 41 people, healthy volunteers welcome
- 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
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.