Clinical trials: Delivery; Injury
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
The goal of this observational study is to understand long-term pelvic floor symptoms and sexual dysfunction after childbirth-related anal sphincter injury in women who gave birth at Tampere University Hospital between 2009 and…
- Conditions
- Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
- Trial name
- NCT07646340
- Where
- Finland
- Volunteers
- 600 people
- Sponsor
- Tampere University Hospital
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Perineal Injury, Perineal Laceration, Tear, or Rupture During Delivery
Targeted Deep Pelvic Floor Muscle Physiotherapy Versus Antenatal Perineal Massage in Nulliparous Women
This prospective randomized clinical trial evaluates whether targeted deep pelvic floor muscle physiotherapy is more effective than standard antenatal perineal massage in reducing perineal trauma among nulliparous women.
- Trial name
- NCT07764068
- Testing
- Targeted Deep Pelvic Floor Muscle Physiotherapy, Standard Antenatal Perineal Massage
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
Perineal Injury, Perineal Pain
TECAR in the Management of Early Postpartum Perineal Pain.
The study aimed to evaluate the effect of TECAR (Capacitive and Resistive Energy Transfer) therapy on the level of pain and discomfort in the pelvic floor in women after an episiotomy or perineal tears, during the first two days…
- Conditions
- Perineal Injury, Perineal Pain, Vaginal Delivery, Instrumental Delivery
- Trial name
- NCT07730372
- Testing
- TECAR - Capacitive and Resistive Energy Transfer
- Where
- Poland
- Volunteers
- 182 people
- Sponsor
- Medical University of Gdansk
Cesarean Section, Delivery; Trauma
Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after…
- Trial name
- EAGLET-CS (NCT07334418)
- Testing
- General anesthetic, Intravenous anesthetic
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- University of Pennsylvania
Healthy Volunteers, Drug Delivery Systems
Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
This is a crossover study to evaluate real-time performance, airflow control, user-device interaction, and safety systems of three portable inhalation systems from the EDDIS platform.
- Conditions
- Healthy Volunteers, Drug Delivery Systems, Inhalation of Liquid Air, Administration Site Injury
- Trial name
- EDDIS-ENG (NCT06902129)
- Testing
- EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Petrov, Andrey
Pregnant Women, Prenatal Yoga
Prenatal Yoga Intervention in Pregnant Women
The aim of this study is to determine the effects of a prenatal yoga intervention on traumatic childbirth perception, self-perception, and delivery preferences in pregnant women.
- Conditions
- Pregnant Women, Prenatal Yoga, Trauma, Body Image
- Trial name
- NCT07585916
- Testing
- Prenatal Yoga
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Episiotomy, Lacerations Perineal
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered…
- Conditions
- Episiotomy, Lacerations Perineal, Obstetric Anal Sphincter Injury, Perineal Injury
- Trial name
- MPR (NCT07170007)
- Testing
- Physiotherapeutic protocol, Usual maternity care
- Where
- Brazil
- Volunteers
- 82 people
- Sponsor
- University of Sao Paulo
Perineal Tear, Delivery; Trauma
The Patient Positioning for Perineal Protection Study
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex.
- Conditions
- Perineal Tear, Delivery; Trauma, Perineal Laceration
- Trial name
- 4P (NCT04616170)
- Testing
- Hip extension, Usual Care
- Where
- United States
- Volunteers
- 1,206 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Site Infection, Cesarean Section; Complications, Wound, Infection (Following Delivery)
Vaginal Microbiota and Post-cesarean SSI
The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery.
- Trial name
- NCT06840041
- Testing
- Vaginal swab and culture
- Where
- Egypt
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Al-Azhar University
Delivery Complication, Delivery Problem
Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis
Aims: Primary aim is to investigate outcomes of eutocic labor, evaluating intrapartum ultrasound parameters by AIDA method: Angle of progression (AoP), Asynclitism degree (AD), fetal head-symphysis distance (HSD), and midline…
- Conditions
- Delivery Complication, Delivery Problem, Delivery; Injury, Delivery; Injury, Maternal
- Trial name
- AIDA (NCT06664112)
- Testing
- AIDA Analysis
- Where
- 2 sites in Italy
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Centro di Ricerca Clinica Salentino
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
Delivery Problem, Delivery Fear
The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
The aim of the study is to compare the births that took place in the Feng Shui Birth unit and those that took place in the standard delivery unit in terms of mother-infant health outcomes.
- Conditions
- Delivery Problem, Delivery Fear, Delivery; Injury, Birth; Prolonged
- Trial name
- NCT05468658
- Testing
- Designing the birthing unit according to the philosophy of Feng Shui
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Birth Outcome, Adverse, Labor Long
How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth.
- Conditions
- Birth Outcome, Adverse, Labor Long, Labor Complication, Maternal Injury
- Trial name
- NCT06420453
- Where
- Sweden
- Volunteers
- 300,000 people
- Sponsor
- Karolinska Institutet
Obstetric Anal Sphincter Injury, Delivery Complication
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04903977
- Testing
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound
- Where
- 5 sites in Czechia, Poland and 2 more
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- OASIS Diagnostics S.A.
Delivery Problem, Childrearing
Perineal Massage Performed During the Labour
In this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain.
- Conditions
- Delivery Problem, Childrearing, Satisfaction, Patient, Perineum; Injury
- Trial name
- NCT05962918
- Testing
- Perinal massage
- Where
- Turkey (Türkiye)
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Munzur University
Surgical Site Infection, Cesarean Section; Complications, Wound, Infection (Following Delivery)
The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections
Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section.
- Conditions
- Surgical Site Infection, Cesarean Section; Complications, Wound, Infection (Following Delivery), Postpartum Complication
- Trial name
- NCT05392400
- Testing
- Steri3X, Control
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
Caridac Output-guided Goal-directed Hemodynamic Therapy, Oxygen Delivery
The Effect of Perioperative Cardiac Output-guided GDT on Oxygen Delivery, Consumption, and Microcirculatory Perfusion
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and…
- Conditions
- Caridac Output-guided Goal-directed Hemodynamic Therapy, Oxygen Delivery, Oxygen Consumption, Microcirculatory Perfusion
- Trial name
- CUSTOM (NCT05090254)
- Testing
- Treatment algorithms targeting cardiac output
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Delivery; Trauma, Covid19
Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship
The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females.
- Trial name
- NCT04609501
- Where
- Israel
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Pregnancy Related, Delivery; Injury, Maternal
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain
The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function.
- Conditions
- Pregnancy Related, Delivery; Injury, Maternal, Pelvic Floor Disorders
- Trial name
- NCT04660708
- Testing
- manual physical therapy
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Milwaukee