Neonatal Outcomes in Instrumental Delivery
- Conditions
- Instrumental Delivery; Nec, Affecting Fetus or Newborn
- Interventions
- Other: instrumental delivery
- Registration Number
- NCT03337880
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- term infant
- non-opposition of the newborn parent
- outborn child
- premature newborn
- newborn transferred
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases instrumental delivery newborns who were delivered with an extractor
- Primary Outcome Measures
Name Time Method Head mark or injury 12 to 72 hours of age 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)
Newborn comfort 12 to 72 hours of age 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)
- Secondary Outcome Measures
Name Time Method Analgesic use 0 to 72 hours of age Any analgesic administration to the newborn will be reported
Length of hospitalisation after childbirth First month of life The day out for home of the newborn will be reported
Trial Locations
- Locations (1)
Poitiers University Hospital
🇫🇷Poitiers, France