Clinical trials: Labor Delivery
Preterm Birth
Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery
Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine.
- Trial name
- CM (NCT04247555)
- Where
- 2 sites in United States
- Volunteers
- 270 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
Respiratory Distress Syndrome (Neonatal), Intubation Complication
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated…
- Conditions
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- Trial name
- Aero-05 (NCT05960929)
- Testing
- Infasurf Aero™
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- ONY
Preterm Labor
PoC Study of OBE022 in Threatened Preterm Labour
This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between…
- Trial name
- PROLONG (NCT03369262)
- Testing
- OBE022, Atosiban
- Where
- 18 sites in Czechia, Finland and 4 more
- Volunteers
- 115 people
- Sponsor
- ObsEva SA
Preterm Birth
Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)
The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and…
- Trial name
- NCT01069744
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- KC BioMediX, Inc
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Cesarean Section
Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer
This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.
- Trial name
- NCT02167438
- Testing
- Hem-Avert Perianal Stabilizer
- Where
- United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Stetrix, 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
PreTerm Labor, Threatened Preterm Labor
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor.
- Conditions
- PreTerm Labor, Threatened Preterm Labor, Preterm Birth
- Trial name
- NCT06157203
- Testing
- Uterine electromyography
- Where
- 2 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- PreTeL, Inc
Preterm Labor
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.
- Trial name
- TERM (NCT02326142)
- Testing
- OBE001
- Where
- 23 sites in Belgium, Germany and 4 more
- Volunteers
- 10 people
- Sponsor
- ObsEva SA
Premature Infant
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups.
- Trial name
- NCT03607942
- Testing
- HMO supplement
- Where
- 7 sites in France
- Volunteers
- 86 people
- Sponsor
- Société des Produits Nestlé (SPN)
Pulmonary Hypertension of Newborn
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow.
- Trial name
- PaTTerN (NCT03132428)
- Testing
- INOmax
- Where
- 30 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mallinckrodt
Birth Defects, Type 2 Diabetes
Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
This is an observational, prospective cohort study describing pregnancy outcomes in women with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any formulation of exenatide during pregnancy.
- Conditions
- Birth Defects, Type 2 Diabetes, Preterm Birth
- Trial name
- Exenatide (NCT00579150)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- AstraZeneca
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Pulmonary Disease, Chronic Obstructive
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with…
- Trial name
- NCT01525615
- Testing
- Respimat inhaler, tiotropium+olodaterol (low dose), tiotropium + olodaterol (high dose)
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 404 people
- Sponsor
- Boehringer Ingelheim
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Obstetric Labour, Premature
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
This study in healthy, adult Japanese women will characterize the PK, safety and tolerability of retosiban at the therapeutic doses planned to be evaluated in Phase 3.
- Trial name
- NCT02377414
- Testing
- Retosiban solution for Infusion
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preterm Delivery
Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥…
- Trial name
- SpecOp (NCT00883324)
- Where
- 5 sites in United States
- Volunteers
- 329 people
- Sponsor
- Hologic, 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
Preterm Infant Health, Premature Babies
Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants.
- Trial name
- NEOMOM (NCT07576972)
- Testing
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Mother's Milk is Best