Clinical trials: Obstetric Trauma
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Obstetric Anal Sphincter Injury
Reproducibility of External Anal Sphincter Elastic Properties Assessment Using Elastography During Pregnancy
The risk prediction of obstetric anal sphincter injury couyl be optimized by considering pregnant women's anal sphincter intrinsic viscoelastic properties.
- Trial name
- SEA ELASTO 1 (NCT04350632)
- Testing
- Shear wave elastography assessment of the external anal sphincter
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Poitiers University Hospital
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
Infection, Obstetric Labor Complications
Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections
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- Conditions
- Infection, Obstetric Labor Complications, Endometritis, Cesarean Delivery Affecting Fetus
- Trial name
- NCT04163679
- Testing
- Vaginal Preparation
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Womack Army Medical Center
Obstetric Anal Sphincter Injury, Episiotomy Wound
Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines.
- Conditions
- Obstetric Anal Sphincter Injury, Episiotomy Wound, Anal Incontinence, Pelvic Floor Disorders
- Trial name
- INSTRUMODA (NCT04446780)
- Testing
- Mediolateral episiotomy
- Where
- France
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Poitiers University 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
Sexual and Gender Minorities, Pregnancy Complications
Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum
Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma.
- Conditions
- Sexual and Gender Minorities, Pregnancy Complications, Obstetric Complication, Psychological Trauma
- Trial name
- NCT05354284
- Testing
- online questionnaire
- Where
- Sweden
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Linkoeping University
Newborn, Infant
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on…
- Conditions
- Newborn, Infant, Hypothermia, Premature
- Trial name
- NCT04463511
- Testing
- Polyethylene bag before the umbilical cord is clamped
- Where
- Ireland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Acute Kidney Injury, Chronic Kidney Disease
Outcomes of Neonatal Acute Kidney Injury In Premature Infants
The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and…
- Trial name
- NCT02375854
- Testing
- Observation
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
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
Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger…
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Trial name
- NCT05617092
- Testing
- Physiotherapy treatment
- Where
- Sweden
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Vastra Gotaland Region
Bronchopulmonary Dysplasia, Preterm Birth
Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of…
- Trial name
- NCT02723513
- Testing
- Hyperpolarized Xenon-129
- Where
- Canada
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Western University, Canada
Episiotomy Wound, Anemia
Use of Tranexamic Acid After Vaginal Delivery with Episiotomy a RCT Placebo Control Trail
The objective of this study is to assess the effect of TA treatment on decline in Hb levels following vaginal delivery with an episiotomy, compared to a control group not receiving TA.
- Conditions
- Episiotomy Wound, Anemia, Early Postpartum Hemorrhage, Hemoglobin
- Trial name
- NCT05448456
- Testing
- Tranexamic acid
- Where
- Israel
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Assuta Ashdod Hospital
Postpartum Depression, Anxiety
Yoga in the NICU for Parents Study
The purpose of this proposal is to test the efficacy of yoga as a mind and body intervention to decrease stress, anxiety, and depression in parents of critically ill neonates hospitalized in the Seattle Children's and University…
- Conditions
- Postpartum Depression, Anxiety, Depression, Stress Disorder
- Trial name
- YiN (NCT05322161)
- Testing
- yoga classes
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Seattle Children's Hospital
Surgical Site Infection Following Cesarean Delivery
The Mepilex Cesarean Delivery Trial
The goal of this clinical trial is to learn whether using a silver-containing antimicrobial foam dressing (Mepilex Ag) can help prevent surgical site infections in patients undergoing cesarean delivery.
- Trial name
- MEPIDEL (NCT07066254)
- Testing
- Mepilex Ag Dressing, Standard Surgical Dressing (Telfa non-adhesive dressing, gauze, and Primapore adhesive bandage)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Premature Infant, Chronic Respiratory Disease
Genesis Electrical Impedance Tomography (EIT): A Preliminary Study
The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in…
- Conditions
- Premature Infant, Chronic Respiratory Disease, Neuromuscular Diseases, Healthy
- Trial name
- NCT03797183
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Obstetric Anal Sphincter Injury
A Comparison of THD® Anopress With High Resolution Anorectal Manometry
Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries).
- Trial name
- NCT07083908
- Testing
- THD® Anopress (Sensyprobe) first, High Resolution Anorectal Manometry first
- Where
- United Kingdom
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- King's College Hospital NHS Trust