Clinical trials: Obstetric Complication
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Labor Complications
Randomized Control Trial of Second Stage of Labor
The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate.
- Trial name
- NCT02101515
- Testing
- Length of Second Stage
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Breech Presentation, External Cephalic Version
Elevation of the Fetal Buttocks Prior to External Cephalic Version
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures.
- Trial name
- NCT04538261
- Testing
- Fetal Pillow insertion
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- AdventHealth
Obstetric Labor Complications, Preeclampsia
Platelet Count Trends in Pre-eclamptic Parturients
Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy; therefore, the platelet count(PC) is routinely…
- Conditions
- Obstetric Labor Complications, Preeclampsia, Thrombocytopenia
- Trial name
- NCT00787241
- Where
- United States
- Volunteers
- 445 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Premature Birth, Absorption; Chemicals
17OHP-C Dosing Among Obese Pregnant Women
Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB…
- Trial name
- NCT03433040
- Testing
- 17-Hydroxyprogesterone Capronate
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- University of South Florida
PreTerm Birth
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).
- Trial name
- VP (NCT02970552)
- Testing
- Vaginal Progesterone
- Where
- Zambia
- Volunteers
- 140 people
- Sponsor
- University of North Carolina, Chapel Hill
Prematurity, Necrotizing Enterocolitis
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants.
- Trial name
- NCT01106209
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Utah
Preterm Labor, Preterm Birth
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
The study is to evaluate the accuracy of a test device called "PAMG-1" to see if a pregnant women has ruptured membranes in comparison to standardly used testing methods.
- Trial name
- PAMG-1 (NCT03715530)
- Testing
- PAMG-1 immunoassay
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Mark Santillan
Preterm Infant
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth.
- Trial name
- NCT03232931
- Testing
- Therapist skin-to-skin Care, Contingent parent's voice exposure, Parental skin-to-skin care
- Where
- 3 sites in United States
- Volunteers
- 248 people
- Sponsor
- Emory University
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Enterocolitis, Necrotizing, Premature Infant
NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful…
- Trial name
- NCT03963011
- Testing
- Bowel Ultrasound
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Children's Mercy Hospital Kansas City
Postpartum Hemorrhage
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage.
- Trial name
- NCT01497756
- Testing
- CAPP use
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of New Mexico
Pain, Postpartum Depression
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term.
- Trial name
- NCT03470675
- Testing
- Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Northwestern University
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
Premature Birth
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
- Trial name
- NCT02357394
- Testing
- Arabin Pessary
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Gene Lee, MD
Uterine Atony, Uterine Atony With Hemorrhage
Calcium Chloride for Prevention of Uterine Atony During Cesarean
In this pilot study, investigators will administer calcium chloride or placebo to pregnant women undergoing Cesarean delivery who have been identified as high risk for hemorrhage due to poor uterine muscle contraction, or atony.
- Conditions
- Uterine Atony, Uterine Atony With Hemorrhage, Cesarean Section Complications
- Trial name
- NCT03867383
- Testing
- Calcium Chloride
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
Herpes Simplex Virus, Neonatal Sepsis
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies. Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been adequately studied in full-term or premature neonates.
- Trial name
- NCT00942084
- Testing
- Acyclovir
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Phillip Brian Smith
Necrotizing Enterocolitis
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs).
- Trial name
- steroids/NEC (NCT01156480)
- Testing
- hydrocortisone
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Endeavor Health
Analgesia, Obstetrical, Postpartum Hemorrhage
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control.
- Conditions
- Analgesia, Obstetrical, Postpartum Hemorrhage, Opioid Use, Nonsteroidals (NSAIDs)Toxicity
- Trial name
- NCT02509312
- Testing
- Ketorolac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis