Clinical trials: Birth Injuries
Quality of Recovery, Anesthesia
Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery
The purpose of this prospective randomized double-blinded and controlled study is to evaluate the quality of recovery after elective cesarean delivery using the Obstetric Quality-of-Recovery-11 (ObsQoR-11) score at 24 hours…
- Conditions
- Quality of Recovery, Anesthesia, Postoperative Pain, Cesarean Section
- Trial name
- CIVIMEC (NCT05696678)
- Testing
- Intrathecal Morphine, Ropivacaine 0.2%
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ciusss de L'Est de l'Île de Montréal
Infection, Soft Tissue, Infection, Wound
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic…
- Conditions
- Infection, Soft Tissue, Infection, Wound, Cellulitis, Diabetic Foot Ulcer
- Trial name
- DAD (NCT01238276)
- Testing
- Cefazolin, Silberg Tissue Preparation System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sonescence, Inc.
Perineal Tear, Perineum; Rupture
Vocalization for the Second Stage of Labor (VOCAL)
A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor.
- Trial name
- VOCAL (NCT03605615)
- Testing
- vocalization
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Wound Healing, Insulin
A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing
The aim of the present study is to evaluate using clinical, patient-centered, immunological, microbiological, and histological parameters, the effect of silk fibroin films loaded or not with insulin in the repair of palatal…
- Conditions
- Wound Healing, Insulin, Palate; Wound
- Trial name
- NCT05171400
- Testing
- Palatal Wound, Palatal Wound treated with Silk Fibroin Film, Palatal Wound treated with Insulin-loaded Silk Fibroin Film
- Where
- Brazil
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Post Partum, Cesarean Birth
The Use of Photobiomodulation for Pain and Healing in Cesarean Section
Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients.
- Conditions
- Post Partum, Cesarean Birth, Pain Management, Wound Care
- Trial name
- NCT07806526
- Testing
- Photobiomodulation (PBM), Standard Hospital Treatment
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Nove de Julho
Retained Surgical Items
Prevention of Retained Items iN Childbirth Environment and Surgical Sites
To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.
- Trial name
- PRINCESS (NCT06570304)
- Testing
- iCount Device
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Pregnancy, Vaginal Delivery
The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety
Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety.
- Trial name
- NCT06426329
- Testing
- Therapeutic Touch
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Cumhuriyet University
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
Surgical Site Infection
Subcutaneous Lavage in Cesarean Section
The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.
- Trial name
- NCT06454227
- Testing
- Subcutaneous washing, no subcutaneous washing
- Where
- Israel
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Surgical Item, Retained, Childbirth
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered…
- Trial name
- PRINCE (NCT05373342)
- Testing
- iCount system assembled with swabs
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Trauma, Childbirth Problems
Study of the Identification of Childbirth Trauma in the Birth Room by Midwives.
Childbirth is a critical moment in this perinatal period, with high unpredictability and risks of medical complications for the mother and child. It can be experienced as a traumatic experience for the woman.
- Trial name
- TOPASE (NCT06204757)
- Testing
- questionary
- Where
- France
- Volunteers
- 1,440 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
NURSING STUDENTS
Vırtual Realıty Glasses' Traumatıc Bırth Perceptıon and Bırth Preferences
Birth is an irreplaceable experience in an individual's life, and can have critical health consequences for both the mother and the baby.
- Trial name
- NCT06810102
- Testing
- VIRTUAL REALITY GLASSES
- Where
- Turkey (Türkiye)
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Firat University
Cesarean Section Complications, Wound Breakdown
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing…
- Conditions
- Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction
- Trial name
- NCT03887299
- Testing
- ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG), Standard Wound Care
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Birth Injuries
The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial
It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior…
- Trial name
- NCT01937546
- Testing
- Primary delivery of anterior shoulder, Primary delivery posterior shoulder
- Where
- Denmark
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Holbaek Sygehus
Obstetric Trauma
Optimizing the Obstetrician's Movement During a Simulated Forceps Operative Vaginal Delivery (PERFORMAC)
Operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries.
- Trial name
- PERFORMAC (NCT04670380)
- Testing
- Posture and movement analysis during a simulated forceps vaginal operative delivery
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Poitiers University Hospital
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric
Perineal Preparation for Pregnant Ladies.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage.
- Conditions
- Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
- Trial name
- NCT03287258
- Testing
- 3 program, one program
- Where
- Egypt
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Kasr El Aini Hospital
HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
Biomarkers Study in Infants With Prior Neonatal Brain Injury
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury.
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
- Trial name
- NCT07413900
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Hypothermia
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization.
- Trial name
- NCT00904228
- Testing
- placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Other Obstetric Trauma - Delivered
Safe Delivery Using a Belt on the Belly of Pregnant Woman
Safety of natural, vaginal labor for parturient, fetus and newborn is one of most important goal among obstetricians, midwifes, scientific society all over the world.
- Trial name
- SDB (NCT01566331)
- Testing
- Baby-guardTM
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Padova