Clinical trials: Complication of Delivery
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
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
Obstetric Pain, Postpartum Depression
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
The objective of this study is evaluate the breastmilk transfer and pharmacokinetics (Part 1) and effectiveness (Part 2) of a post-cesarean delivery intravenous ketamine bolus-and-infusion strategy, as a preventive analgesic…
- Conditions
- Obstetric Pain, Postpartum Depression, Breastfeeding, Pain, Acute
- Trial name
- KINETIC (NCT04037085)
- Testing
- Ketamine
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Grace Lim, MD, MS
Retinopathy of Prematurity, Retinal Detachment
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be…
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Trial name
- ROP (NCT00634972)
- Testing
- ACULAR, REFRESH TEARS
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
Pregnancy Preterm, Pregnancy Prom
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane…
- Conditions
- Pregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy)
- Trial name
- NCT05345457
- Testing
- Azithromycin Pill, Amoxicillin Pill
- Where
- 3 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Preterm Birth, Health Care Utilization
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before…
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage
- Trial name
- NCT05120843
- Testing
- Care coordination and motivational interviewing
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Contraception
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects.
- Trial name
- NCT00775190
- Testing
- ortho tricyclen, Trinessa
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
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
Pregnancy; Habitual Aborter, Weeks of Gestation 37 or More
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor.
- Trial name
- NCT01280357
- Testing
- Monica AN24 (K101081), Philips 50XM
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
Labor Pain, Complications; Cesarean Section
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).
- Conditions
- Labor Pain, Complications; Cesarean Section, Pregnancy
- Trial name
- NCT02105558
- Testing
- Epidural anesthesia, Combined spinal and epidural anesthesia
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Postpartum Hemorrhage
Accuracy of Blood Loss Estimation After Vaginal Delivery
Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality.
- Trial name
- NCT00462839
- Testing
- blood loss estimation
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Birth, Spontaneous Abortion
The Effects of Aspirin in Gestation and Reproduction
The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared…
- Trial name
- EAGeR (NCT00467363)
- Testing
- acetylsalicylic-acid (aspirin), Folic acid
- Where
- 4 sites in United States
- Volunteers
- 1,228 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Pain, Postoperative
An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for…
- Trial name
- NCT00859313
- Testing
- Sufentanil NanoTab PCA System/15 mcg
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Preterm Birth
Tennessee Connections for Better Birth Outcomes
Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention.
- Trial name
- BBO (NCT00502697)
- Testing
- Targeted Nurse Home Visits, Conventional prenatal/postpartum care
- Where
- United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Preterm Birth
Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth
The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth.
- Trial name
- PRO (NCT03292731)
- Testing
- 17-Hydroxyprogesterone caproate 250mg or 500 mg., Safety study of 500 mg dose.
- Where
- 5 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Steve N. Caritis, MD