Clinical trials: Labor, Obstetric
Preterm Birth
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of…
- Trial name
- PROLONG (NCT01004029)
- Testing
- Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
- Where
- 104 sites in United States, Bulgaria and 7 more
- Volunteers
- 1,740 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
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
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Newborn, Birth, Preterm
Pulse Oximetry Performance Comparison in Newborns
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
- Trial name
- NCT06637917
- Testing
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Preterm Birth
Cervix Monitor for Elasticity and Length Measurements
Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine.
- Trial name
- NCT03199079
- Testing
- Measurement
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Advanced Tactile Imaging, Inc.
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
Shoulder Dystocia
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.
- Trial name
- NCT05913609
- Testing
- Yaari Extractor
- Where
- 4 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- FetalEase Ltd.
Labor, Obstetric
Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest
The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels…
- Trial name
- NCT03001193
- Testing
- DF 01, Oxytocin
- Where
- 12 sites in Denmark, Finland and 1 more
- Volunteers
- 361 people, healthy volunteers welcome
- Sponsor
- Dilafor AB
Obstetric Labour, Premature
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects.
- Trial name
- NCT01702376
- Testing
- Retosiban 100 mg, Retosiban 800 mg, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preterm Delivery
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening…
- Trial name
- NCT01009723
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Esoterix Genetic Laboratories, LLC
Prematurity, Vascular Aging
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.
- Trial name
- NEOVASC (NCT04413994)
- Testing
- Humavant
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Prolacta Bioscience
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Preeclampsia
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
- Trial name
- SAVE (NCT02923206)
- Testing
- TheraSorb sFlt-1 adsorber
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Miltenyi Biomedicine GmbH
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
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
Prematurity, Premature Birth
Vibroacoustic Study of Lung Development in Newborn Infants
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.
- Conditions
- Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme
- Trial name
- NCT05827250
- Testing
- imPulse Tor
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Level 42 AI, Inc.
Infant, Extremely Premature, Length of Stay
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Trial name
- NCT01158391
- Testing
- NTrainer® Intervention, Control Intervention
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- KC BioMediX, Inc