Clinical trials: Obstetric Labor Complications
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
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)
Post Partum Hemorrhage
Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
- Trial name
- NCT04364386
- Testing
- InPress Device
- Where
- 2 sites in Indonesia
- Volunteers
- 10 people
- Sponsor
- Alydia Health
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
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
Prematurity
Early DHA Supplementation in Very Low Birth Weight Infants
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
- Trial name
- NCT03192839
- Testing
- Low dose PUFA, High dose PUFA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mead Johnson Nutrition
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 Infants, Parenteral Nutrition n-3 Fatty Acids
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory…
- Trial name
- NCT00497289
- Testing
- Lipofundin MCT/LCT 20 %, Lipidem 20%
- Where
- 2 sites in Germany
- Volunteers
- 48 people
- Sponsor
- B. Braun Melsungen AG
Preterm Birth
Evaluating Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance
This is a research study to determine if an experimental device called the NTrainer can improve oral feeding skills more quickly and more effectively than traditional methods in infants who are at high risk of feeding dysfunction…
- Trial name
- NCT01069718
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- KC BioMediX, Inc