Clinical trials: Obstetric 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
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 Heal
Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological…
- Trial name
- NCT07525674
- Testing
- Conventional Wound Care Group, Vacuum Sealing Drainage (VSD) Group
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Minia University
Obstetric Anal Sphincter Injury, Anal Incontinence
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal…
- Conditions
- Obstetric Anal Sphincter Injury, Anal Incontinence, Urinary Incontinence, Sexual Dysfunction
- Trial name
- PFF (NCT05832268)
- Testing
- Obstetric Anal Sphincter Injury
- Where
- Norway
- Volunteers
- 900 people
- Sponsor
- Oslo University Hospital
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
Obstetric Labor Complications, Obstetric Trauma
Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal…
- Trial name
- NCT06049784
- Testing
- Visual Biofeedback using self operated home ultrasound device, Visual Biofeedback using ultrasound at hospital
- Where
- Israel
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
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
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
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the…
- Conditions
- Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
- Trial name
- AMNIO-BRAIN (NCT07610642)
- Testing
- Intrauterine Pressure Catheter, Standard obstetric care at discretion of delivery provider
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medical College of Wisconsin
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
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
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
Bleeding, Aortic Rupture
Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting
The overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock.
- Conditions
- Bleeding, Aortic Rupture, Gastrointestinal Hemorrhage, Obstetric Bleeding
- Trial name
- NCT07012863
- Testing
- Dry plasma
- Volunteers
- 650 people
- Sponsor
- Vastra Gotaland Region
Mother to Child Transmission, Breast Feeding
Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study
The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for…
- Conditions
- Mother to Child Transmission, Breast Feeding, Trauma
- Trial name
- NCT07195058
- Testing
- Trauma Informed Obstetric Care (TIOC)
- Where
- Argentina
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Columbia University
Obstetric Anal Sphincter Injury
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation
The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.
- Trial name
- 3D_TV_OASIS (NCT06773520)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Cesarean Section, Surgical Site Infection
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery.
- Conditions
- Cesarean Section, Surgical Site Infection, Wound Dehiscence, Seroma
- Trial name
- STRIP-CS (NCT07686913)
- Testing
- Steri-Strip™ Skin Closures, Standard Cesarean Wound Closure
- Where
- United States
- Volunteers
- 610 people
- Sponsor
- Riverside University Health System Medical Center
Bronchopulmonary Dysplasia
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data
Early Prediction of Bronchopulmonary Dysplasia in Preterm Infants Using Clinical Data from the First Three Postnatal Weeks with Large Language Models: A Retrospective Study This retrospective, observational study aims to evaluate…
- Trial name
- NCT07525167
- Testing
- Artificial Intelligence-Based Risk Prediction
- Where
- Turkey (Türkiye)
- Volunteers
- 108 people
- Sponsor
- Konya City Hospital
Bronchopulmonary Dysplasia
The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)
Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
- Trial name
- INFANCY (NCT06342752)
- Testing
- Breath test, Throat swabs, Placental samples
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp