Clinical trials: Preterm Labor With Preterm Delivery
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
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
Labor, Premature, Premature Birth
A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
To determine the effects of four different single bolus doses of FE200440 administered intravenously on stopping preterm labour compared to placebo in pregnant women with advanced gestational age
- Trial name
- NCT00209326
- Testing
- FE200440
- Where
- 17 sites in Belgium, Czechia and 4 more
- Volunteers
- 163 people
- Sponsor
- Ferring Pharmaceuticals
Intra-amniotic Infection, Preterm Birth
Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes
The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)
- Trial name
- PPROM (NCT00701350)
- Where
- 4 sites in United States
- Volunteers
- 79 people
- Sponsor
- ProteoGenix, Inc.
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
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.
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 Birth, Placenta Previa
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm)…
- Trial name
- NCT01442207
- Testing
- Placement of a Cervical Cerclage, Standard Expectant Management
- Volunteers
- healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Preterm Delivery
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1.
- Trial name
- 17PinPROM (NCT01119963)
- Testing
- 17-alpha-hydroxy-progesterone caproate, Makena®
- Where
- 15 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
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 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
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
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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.
Intra-amniotic Infection
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic…
- Trial name
- IAI (NCT00700219)
- Where
- 21 sites in United States
- Volunteers
- 900 people
- Sponsor
- ProteoGenix, Inc.
Obstetric Labour, Premature
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4…
- Trial name
- NCT01627587
- Testing
- GSK221149 750 mg, Ketoconazole, GSK221149 100 mg
- Where
- United States
- Volunteers
- 46 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
Preterm Labor, PreTerm Birth
Electrical Inhibition of Human Preterm Contractions
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration…
- Conditions
- Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
- Trial name
- NCT02983240
- Testing
- Electrical Uterine Pacemaker
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- e-Bio Corp