Clinical trials: Birth, Preterm
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.
Preterm Infant
The FOUNDATION Study
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint.
- Trial name
- FOUNDATION (NCT03939546)
- Testing
- B. infantis EVC001
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Evolve BioSystems, Inc.
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
A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation.
- Trial name
- TREETOP (NCT02787213)
- Where
- 18 sites in United States
- Volunteers
- 5,011 people
- Sponsor
- Sera Prognostics, Inc.
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, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
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
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
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
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 Infant
Growth and Safety of a Two-stage Feeding System in Preterm Infants
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
- Trial name
- NCT03728764
- Testing
- Preterm infant formula
- Where
- 4 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Preterm Delivery
Neonatal Outcome by Reason for Delivery
To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM).
- Trial name
- NCT01818518
- Where
- 10 sites in United States
- Volunteers
- 995 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Preterm Birth
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34…
- Trial name
- PCP002 (NCT02225353)
- Testing
- Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, Progesterone Cervical Pessary 7.7 g
- Where
- 4 sites in Chile
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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
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
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
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 Birth
Proteomic Assessment of Preterm Birth
The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.
- Trial name
- PAPR (NCT01371019)
- Where
- 13 sites in United States
- Volunteers
- 5,500 people
- Sponsor
- Sera Prognostics, Inc.
Preterm Delivery
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks'…
- Trial name
- ACS (NCT00201643)
- Testing
- Betamethasone or Dexamethasone (2nd course of ACS)
- Where
- 22 sites in United States
- Volunteers
- 437 people
- Sponsor
- Obstetrix Medical Group
Preterm Delivery, Preterm Birth
fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Among women with a twin pregnancy, currently enrolled in a study in which they are receiving weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal fibronectin (fFN) and salivary estriol (E3 )…
- Trial name
- NCT00156000
- Testing
- Fetal Fibronectin, Salivary Estriol
- Where
- 2 sites in United States
- Sponsor
- Obstetrix Medical Group
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
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