An observational study in Instrumental Delivery; Nec, Affecting Fetus or Newborn, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 12 Hours to 72 Hours. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Poitiers University Hospital · Observational
The aim of this study is to compare the impact of instrumental delivery on newborn head mark and newborn comfort over the impact of non-instrumental delivery. It is also to evaluate how mothers age, Body Mass Index, instrumental extraction indication, extractor type, variety and height of the fetal presentation, operator, time of birth (day or night) and birth weight impact on head mark existence and newborn comfort.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 300 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
mature newborns who profit an instrumental delivery or not.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
newborns who were delivered with an extractor
Other: instrumental delivery
newborns who were not delivered with an extractor
the birth was assisted with an extractor.
Head mark or injury
Any mark or injury (skin erosion, wound, hematoma, fracture, paralysis, etc.) on the newborn head will be described (type, color, size, position) and documented (photo)
Time frame: 12 to 72 hours of age
Newborn comfort
assessed using Newborn Pain and Discomfort Scale (EDIN) (DEBILLON et al. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Neonatal Ed 2001;85:36-41)
Time frame: 12 to 72 hours of age
Analgesic use
Any analgesic administration to the newborn will be reported
Time frame: 0 to 72 hours of age
Length of hospitalisation after childbirth
The day out for home of the newborn will be reported
Time frame: First month of life
Ran from Dec 2017 to primary completion in Oct 2018, 10 months.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Poitiers University Hospital →