Clinical trials: Labor Delivery
Premature Birth, Pregnancy Preterm
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California.
- Conditions
- Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety
- Trial name
- EMBRACE (NCT04154423)
- Testing
- Glow! Group Prenatal Care, Individual Prenatal Care with CPSP
- Where
- 2 sites in United States
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke University
Docosohexaenoic Acid Supplementation of Mothers to
DHA Supplementation for Lactating Mothers
The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function.
- Trial name
- DHA-1 (NCT01732874)
- Testing
- Expecta 200 mg, Expecta 1 gram
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Labor; Prolonged, Second Stage, Episiotomy Wound
The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.
- Trial name
- NCT06379048
- Testing
- Mattress Suturing, Primary Suturing, Continuous Subcutaneous Suturing
- Where
- Turkey (Türkiye)
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Prematurity, Intestine Perforation
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants.
- Conditions
- Prematurity, Intestine Perforation, Necrotizing Enterocolitis (NEC), Short Bowel Syndrome (SBS)
- Trial name
- EMLFO-2 (NCT01674478)
- Testing
- Microlipid with fish oil, Microlipid
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Wake Forest University
Labor Pain, Obstetric Pain
Association Between Bolus Rate and the Adequacy of Labor Analgesia Using Timed-intermittent Boluses
Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia…
- Trial name
- NCT02340806
- Testing
- CADD-Solis pump (Smiths Medical)
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Labor; Forced or Induced, Affecting Fetus or Newborn
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery…
- Trial name
- NCT02680314
- Testing
- Misoprostol
- Volunteers
- 243 people
- Sponsor
- Montefiore Medical Center
Hyponatremia, Premature
Early Sodium Intake in Preterm Newborns
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome.
- Trial name
- NCT04035564
- Testing
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Where
- Mexico
- Volunteers
- 52 people
- Sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
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
Intrauterine Fetal Demise, Fetal Death
Mifepristone Induction for Fetal Demise
Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater.
- Trial name
- MIFD (NCT02620904)
- Testing
- Mifepristone
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Premature Birth, Decision Making
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners.
- Conditions
- Premature Birth, Decision Making, Prenatal Care, Resuscitation
- Trial name
- NCT04093492
- Testing
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention, ACOG links
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
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
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
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
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries
Placenta, Retained, Postpartum Hemorrhage
Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness.
- Trial name
- NCT00120042
- Testing
- Misoprostol, Oxytocin
- Where
- Australia
- Volunteers
- 251 people
- Sponsor
- The University of Western Australia
Patent Ductus Arteriosus, Preterm Infant
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing…
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia
- Trial name
- NCT03701074
- Testing
- Ibuprofen and acetaminophen
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of South Alabama