Clinical trials: Birth Trauma, open to volunteers
Anxiety
An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial
This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is…
- Trial name
- VITAL (NCT07064213)
- Testing
- Behavioral: Educational Video
- Where
- Israel
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
Cesarean Section, Surgical Wound Infection
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index [BMI] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical…
- Conditions
- Cesarean Section, Surgical Wound Infection, Wound Healing, Obesity
- Trial name
- NCT07846930
- Volunteers
- 726 people
- Sponsor
- Assiut University
Bronchopulmonary Dysplasia (BPD)
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).
- Trial name
- PRELUDE (NCT07652684)
- Testing
- Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, Standard care and feeding
- Where
- Greece
- Volunteers
- 74 people
- Sponsor
- Aristotle University Of Thessaloniki
Wound of Skin, Burns
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine.
- Trial name
- NCT05217160
- Testing
- KeraStat® Gel with Morphine application, KeraStat® Gel application
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- The Metis Foundation
Bronchopulmonary Dysplasia (BPD)
Metformin for Premature Infants With Bronchopulmonary Dysplasia
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study.
- Trial name
- NCT07120971
- Testing
- Metformin (open-label)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Stress Disorders, Post-Traumatic, Psychological Trauma
Postnatal Debriefing After Adverse Obstetric Events
Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress.
- Conditions
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period
- Trial name
- DBIRTH (NCT07579273)
- Testing
- Structured Postnatal Debriefing, Usual Care
- Volunteers
- 142 people
- Sponsor
- Parc de Salut Mar
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Coronary Heart Disease, Acute Myocardial Infarction
Twenty-year Follow-up of the Inter99 Cohort
Being born small increases your risk of developing Type 2 diabetes (T2D) with age. Furthermore, data even suggest that some of the diseases ("complications") in the eyes, kidneys, nerves, liver, blood vessels and heart often seen…
- Conditions
- Coronary Heart Disease, Acute Myocardial Infarction, Cardiovascular Diseases, Type 2 Diabetes
- Trial name
- NCT05166447
- Where
- Denmark
- Volunteers
- 4,000 people
- Sponsor
- Bispebjerg Hospital
Maternal Pushing Techniques, Perineal Trauma
Vocalization and Spontaneous Pushing in the Second Stage of Labor
The second stage of labor, defined as the period from full cervical dilatation to fetal birth, is a critical phase in which maternal pushing techniques may significantly affect maternal and neonatal outcomes (1-5).
- Conditions
- Maternal Pushing Techniques, Perineal Trauma, Maternal Fatigue, Labor
- Trial name
- NCT07316348
- Testing
- The vocalization straining technique will be used.
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Perineal Trauma, Postpartum Pain
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal tears and episiotomies are common after vaginal birth and may cause persistent pain, impaired wound healing, pain during sexual activity, and concerns about genital appearance.
- Conditions
- Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
- Trial name
- RELIEVE (NCT07727213)
- Testing
- Autologous Non-Activated Platelet-Rich Plasma, Saline (0.9%, sterile, for infusion)
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Hospital, Geneva
Burn, Hypertrophic Scars
Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars
Burn scars can sometimes heal in a way that causes them to become thick, raised, and stiff. These scars may itch, feel uncomfortable, limit movement, and affect how the skin looks.
- Conditions
- Burn, Hypertrophic Scars, Scar Improvement by Laser, CO2 Laser in Scars
- Trial name
- NCT07660120
- Testing
- Fractional Ablative CO₂ Laser, Triamcinolone Acetonide, Fluorouracil (5-FU)
- Volunteers
- 65 people
- Sponsor
- University of California, Davis
Hypoxic-Ischemic Encephalopathy
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period.
- Trial name
- NCT07292220
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mustafa Gürkan
Skin Injury, Premature Birth
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few…
- Conditions
- Skin Injury, Premature Birth, Medical Adhesive Related Skin Injury
- Trial name
- NCT07864298
- Testing
- Cohesive bandage fixation of pulse oximeter probe, Standard adhesive fixation of pulse oximeter probe
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people
- Sponsor
- Uskudar University
Sphincter (Anal); Perineal Rupture, Obstetric
Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid…
- Trial name
- NCT07474012
- Testing
- Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy
- Volunteers
- 110 people
- Sponsor
- IRCCS San Raffaele
Post Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD
Building Ukraine's Strength in PTSD Treatment and Research
The Lux4UA project aims to support mental health treatment in Ukraine, especially for those who have experienced traumatic events due to the ongoing conflict and forced displacement.
- Conditions
- Post Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD, Post-Traumatic Stress Disorder, PTSD
- Trial name
- Lux4UA (NCT07318181)
- Testing
- Reconsolidation of Traumatic Memories Protocol, Trauma-Focused Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing
- Where
- 2 sites in Ukraine
- Volunteers
- 120 people
- Sponsor
- University of Luxembourg
Bronchopulmonary Dysplasia
Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation.
- Trial name
- LUS_BPD (NCT07633184)
- Testing
- Lung ultrasound at 7 (±1) days of life, Lung ultrasound at 14 (±2) days of life
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.
- Trial name
- CS-PREO (NCT06614829)
- Testing
- Stratafix Suture, DERMABOND PRINEO
- Where
- Canada
- Volunteers
- 68 people
- Sponsor
- North York General Hospital
Pain Management, C Section
Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
The goal of this observational study is to learn whether injecting a numbing medicine (levobupivacaine, a local anesthetic) into the surgical wound at the end of a cesarean delivery improves pain control in women who also receive…
- Conditions
- Pain Management, C Section, Obstetric Pain, Levobupivacaine
- Trial name
- LEVO-CS (NCT07859956)
- Testing
- Levobupivacaine, Intrathecal Morphine
- Where
- Colombia
- Volunteers
- 336 people
- Sponsor
- Fundación Santa Fe de Bogota
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia