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Neonatal Outcomes in Instrumental Delivery

Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03337880
Enrollment
300
Registered
2017-11-09
Start date
2017-12-04
Completion date
2018-10-04
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Instrumental Delivery; Nec, Affecting Fetus or Newborn

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.

Interventions

OTHERinstrumental delivery

the birth was assisted with an extractor.

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Hours to 72 Hours
Healthy volunteers
No

Inclusion criteria

* term infant * non-opposition of the newborn parent

Exclusion criteria

* outborn child * premature newborn * newborn transferred

Design outcomes

Primary

MeasureTime frameDescription
Head mark or injury12 to 72 hours of ageAny 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 comfort12 to 72 hours of ageassessed 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

MeasureTime frameDescription
Analgesic use0 to 72 hours of ageAny analgesic administration to the newborn will be reported
Length of hospitalisation after childbirthFirst month of lifeThe day out for home of the newborn will be reported

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026