Clinical trials: Preterm Delivery
Pregnant With Complication, Preeclampsia
Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test
This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk…
- Conditions
- Pregnant With Complication, Preeclampsia, Preterm Birth, Gestational Diabetes
- Trial name
- NCT06385366
- Where
- Vietnam
- Volunteers
- 1,105 people
- Sponsor
- Gene Solutions
Threatened Preterm Labor
FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm…
- Trial name
- FB-CT2 (NCT06968364)
- Testing
- Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation., Transvaginal ultrasound
- Where
- 14 sites in Spain
- Volunteers
- 457 people, healthy volunteers welcome
- Sponsor
- Ultrasound-Innovation Medtech, S.L.
Pregnancy
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication).
- Trial name
- NCT00086177
- Testing
- 8% progesterone vaginal gel
- Where
- 45 sites in United States
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.
Antioxidant Role of the Lutein in Preterm Newborn
Early Administration of the Lutein/Zeaxanthin in Premature Newborns
Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system…
- Trial name
- NCT03340103
- Testing
- LUTEIN ofta 0,5 gocce
- Where
- 4 sites in Italy
- Sponsor
- Sooft Italia
Retinopathy of Prematurity
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
- Trial name
- RAINBOW (NCT02375971)
- Testing
- Ranibizumab, Laser therapy
- Where
- 86 sites in United States, Austria and 24 more
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
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
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
Prematurity
Probiotics Supplementation in Premature Infants
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
- Trial name
- NCT01379417
- Testing
- Probiotic supplementation
- Where
- 3 sites in France
- Volunteers
- 199 people
- Sponsor
- Société des Produits Nestlé (SPN)
Preterm Birth, Cervical Incompetence
Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study
The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating…
- Conditions
- Preterm Birth, Cervical Incompetence, Cervical Insufficiency, Short Cervix
- Trial name
- NCT05512052
- Testing
- Hannah Cervical Cup (2 mm Delta), Hannah Cervical Cup (4 mm Delta), Hannah Cervical Cup (6 mm Delta)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Galena Innovations, LLC
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
Pre-term Infants
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization.
- Trial name
- NCT01766011
- Testing
- study pre-term formula
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Abbott Nutrition
Pre Term Labor, Multiple Pregnancy
Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.
- Trial name
- NCT01360905
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Infant, Premature, Infant, Newborn
A Study of Cisapride in Premature Infants With Feeding Problems
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
- Trial name
- NCT01281566
- Testing
- Cisapride
- Volunteers
- 8 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Preterm Birth
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm…
- Trial name
- 170HP (NCT00163020)
- Testing
- 17-alpha-hydroxyprogesterone caproate injectable
- Where
- 18 sites in United States
- Volunteers
- 321 people
- Sponsor
- Obstetrix Medical Group
Preterm Delivery, Short Cervix
PREGNANT Short Cervix Trial
The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.
- Conditions
- Preterm Delivery, Short Cervix, Short Uterine Cervical Length
- Trial name
- NCT00615550
- Testing
- progesterone
- Where
- 49 sites in United States, Belarus and 8 more
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Intra-Amniotic Infection of Foetus
Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected…
- Trial name
- NCT03497234
- Testing
- Perilynx Analyzer to measure AF and VF fluid
- Where
- 5 sites in United States
- Sponsor
- Hologic, Inc.
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.