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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial looks at whether a new syringe makes it easier to get pain relief during childbirth, and if it's faster to learn how to use for medical residents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success of epidural localization
Side effects data
From 2020 Phase 3 trial • 10 Patients • NCT0357151660%
Vomiting
40%
Frequent bowel movements
40%
Diarrhoea
40%
Nasopharyngitis
20%
Sleep disorder
20%
Device occlusion
20%
Irritability
20%
Retching
20%
Device breakage
20%
Secretion discharge
20%
Abnormal faeces
20%
Mucous stools
20%
Gastroenteritis norovirus
20%
Viral infection
20%
Lip injury
20%
Abdominal distension
20%
Faeces discoloured
20%
Flatulence
20%
Gastrointestinal sounds abnormal
20%
Pyrexia
20%
Medical device site infection
20%
Respiratory tract infection viral
20%
Upper respiratory tract infection
20%
Alanine aminotransferase increased
20%
Faecal volume increased
20%
Serum ferritin decreased
20%
Cough
20%
Rhinorrhoea
20%
Eczema
20%
Device leakage
20%
Dermatitis diaper
20%
Anaemia
20%
Iron deficiency anaemia
20%
Abdominal discomfort
20%
Immunisation reaction
20%
Decreased appetite
20%
Hypophagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teduglutide (TED)
Standard of Care (SOC)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EpiFaith® groupExperimental Treatment1 Intervention
Study subject will have the epidural placement with an EpiFaith® syringe.
Group II: Conventional groupActive Control1 Intervention
Study subject will have the epidural placement with a conventional glass syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Syringe
2018
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
Harvard Medical SchoolLead Sponsor
29 Previous Clinical Trials
40,849 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)Lead Sponsor
194 Previous Clinical Trials
1,316,709 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available in this trial for participants?
"Affirmative. According to the information found on clinicaltrials.gov, this research is still seeking out participants and has been since its posting date of May 15th 2022. Most recently updated June 3rd 2022, 680 patients are needed at 1 medical site."
Answered by AI
How many participants are currently enrolled in this research endeavor?
"Affirmative. The information available on clinicaltrials.gov suggests that enrollment is open for this trial, which was initially posted on May 15th 2022 and last updated June 3rd 2022. This study seeks to recruit 680 patients from a single medical institution."
Answered by AI
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