Clinical trials: Vacuum Extraction, Obstetrical
Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor
R. I. S. POS. T. A
A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.
- Conditions
- Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery
- Trial name
- RISPOSTA (NCT01991665)
- Testing
- Digital examination, Sonography evaluation
- Where
- Italy
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- University of Bologna
Pelvic Floor Disorders, Fecal Incontinence
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Nulliparous women with a live singleton pregnancy in cephalic presentation past 34 gestational weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal delivery by vacuum extraction is indicated.
- Conditions
- Pelvic Floor Disorders, Fecal Incontinence, Dystocia, Fetal Hypoxia
- Trial name
- EVA (NCT02643108)
- Testing
- Lateral episiotomy
- Where
- 8 sites in Sweden
- Volunteers
- 717 people
- Sponsor
- Karolinska Institutet
Healthy
Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section
The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery…
- Trial name
- NCT00311142
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Sheba Medical Center
Uterine Prolapse, Urinary Incontinence
Delivery Method and Risk for Urogenital Prolapse 15-20 Years Later
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse.
- Conditions
- Uterine Prolapse, Urinary Incontinence, Fecal Incontinence
- Trial name
- uropro (NCT01766193)
- Testing
- vaginal delivery, forceps extraction, vacuum extraction
- Where
- Norway
- Volunteers
- 1,641 people
- Sponsor
- Norwegian University of Science and Technology
Vacuum Extraction
Development of a Risk Score to Predict the Vacuum Extraction Failure
Safe operative vaginal delivery requires a careful assessment of the clinical situation. During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean…
- Trial name
- FADS (NCT03853499)
- Testing
- No intervention (observational study)
- Where
- France
- Volunteers
- 1,743 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Surgery
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction
In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal teaching using a Training Video for learning how to perform an assisted delivery by vacuum extraction on a pelvic Training model.
- Trial name
- VAC-OSATS (NCT02468427)
- Testing
- hands-on teaching, Frontal teaching
- Where
- Germany
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Ruhr University of Bochum
Obstetric Labor Complications, Vacuum Extraction; Failure, Affecting Fetus or Newborn
Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.
- Conditions
- Obstetric Labor Complications, Vacuum Extraction; Failure, Affecting Fetus or Newborn, Complicated Labour/Delivery Livebirth
- Trial name
- NCT04888871
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Dystocia, Contractions
Internal Versus External Tocodynamometry and Labor Outcome
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous…
- Trial name
- NCT02941393
- Testing
- Intrauterine pressure catheter, External tocodynamometry
- Where
- 2 sites in Finland
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital
Pain
Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?
There are many reasons for using a vacuum apparatus or forceps to assist in delivering a baby. The traction and pressure on the baby's head due to the vacuum apparatus or forceps may cause pain and discomfort for some time after…
- Trial name
- NCT00488540
- Testing
- Paracetamol
- Where
- 3 sites in Switzerland
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Pregnant Women
Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
- Trial name
- E-SAFE-ODON (NCT07862842)
- Testing
- Experimental: The BD Odon DeviceTM, Active Comparator: Vacuum extraction group
- Volunteers
- 628 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Vacuum Extraction, Obstetrical, Randomized Controlled Trials
a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.
The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning
- Conditions
- Vacuum Extraction, Obstetrical, Randomized Controlled Trials, Failures, Medical Device, Maternal Lesions
- Trial name
- ICUP (NCT01058200)
- Testing
- iCup, reference cup
- Where
- 6 sites in France
- Volunteers
- 668 people
- Sponsor
- University Hospital, Grenoble
Labor Pain, Pregnancy
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
The objective of this study will be to compare epidural infusion management, specifically looking at infusion rate changes, in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries.
- Trial name
- NCT00443560
- Testing
- Case controlled analysis of epidural labor analgesia patterns
- Where
- United States
- Volunteers
- 2,162 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Hypoxic Ischemic Encephalopathy, Neonatal Convulsions
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.
- Conditions
- Hypoxic Ischemic Encephalopathy, Neonatal Convulsions, Subgaleal Hematoma
- Trial name
- SVEA (NCT03071783)
- Testing
- Vacuum extraction intelligent system
- Where
- Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska Institutet