Clinical trials: Pre-term Delivery
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, Newborn
Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube…
- Trial name
- NCT01042600
- Testing
- Endotracheal tube insertion, Laryngeal mask airway insertion
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Albany Medical College
Preterm Birth
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention.
- Trial name
- NCT04149002
- Testing
- Intervention Arm Weekly IP3 text messages, Active Control Arm General pregnancy text messages
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Preterm Delivery, Cervical Length
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the…
- Trial name
- SCAN (NCT00439374)
- Testing
- 17 alpha-hydroxyprogesterone caproate
- Where
- 14 sites in United States
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Obstetric Labour, Premature
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00404768
- Testing
- GSK221149A
- Where
- 57 sites in United States, Argentina and 9 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Low Birthweight, Pre-Term
Low-birthweight Infant Feeding Exploration
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs).
- Trial name
- LIFE (NCT04002908)
- Where
- 3 sites in India, Malawi and 1 more
- Volunteers
- 3,188 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Pregnancy, Premature Rupture of Membranes
Cervical Ripening in Premature Rupture of Membranes
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the vaginal canal before the onset of labor.
- Conditions
- Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes, Unfavorable Cervix
- Trial name
- NCT02314728
- Testing
- Misoprostol, Oxytocin
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Respiratory Distress Syndrome, Newborn
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and…
- Trial name
- NCT00244101
- Testing
- PS Group, NCPAP Group, ISX Group
- Where
- United States
- Volunteers
- 648 people
- Sponsor
- Vermont Oxford Network
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 Birth, Short Cervix
Prevention of Preterm Birth With a Pessary in Singleton Gestations
Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually.
- Trial name
- PoPPS (NCT02056652)
- Testing
- Bioteque cup pessary
- Where
- 4 sites in United States
- Volunteers
- 122 people
- Sponsor
- University of Pennsylvania
Postpartum Depression, Small for Gestational Age at Delivery
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder…
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety
- Trial name
- HMHB (NCT03880032)
- Testing
- Cognitive Behavioral Therapy Intervention for Anxiety
- Where
- Pakistan
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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.
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
Pre-term Birth, HIV-1-infection
Improving Pregnancy Outcomes With Progesterone
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
- Trial name
- IPOP (NCT03297216)
- Testing
- 17P
- Where
- 2 sites in Zambia
- Volunteers
- 800 people
- Sponsor
- University of North Carolina, Chapel Hill
Preterm Birth
Cervix Monitor for Elasticity and Length Measurements
Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine.
- Trial name
- NCT03199079
- Testing
- Measurement
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Advanced Tactile Imaging, Inc.
Hyperinsulinemia, Miscarriages
Maternal Lifestyle and Neonatal Hypoglycemia
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane…
- Conditions
- Hyperinsulinemia, Miscarriages, Pregnancy, Sedentary Lifestyle
- Trial name
- NCT01409382
- Testing
- Daily brisk walking plus a carbohydrate-restricted diet
- Where
- Brazil
- Volunteers
- 480 people
- Sponsor
- Hospital dos Servidores do Estado do Rio de Janeiro
Pre-term Birth, Delayed Cord Clamping
Cord Clamping Level Above or Below Mother's Perineum
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.
- Trial name
- CLAMP (NCT02659605)
- Testing
- Delayed cord clamping above the perineum, Delayed cord clamping below the perineum
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston
Premature Birth
Neonatal Resuscitation - Sustained Inflations
This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.
- Trial name
- NCT02967562
- Testing
- Inflation Breaths, Sustained Inflation
- Where
- United Kingdom
- Volunteers
- 63 people
- Sponsor
- King's College London