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Completed

NCT Number: NCT03337880

Neonatal Outcomes in Instrumental Delivery

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.

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Key information

Conditions

Instrumental Delivery; Nec, Affecting Fetus or Newborn Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

12 hour–72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Poitiers University Hospital

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • term infant
  • non-opposition of the newborn parent

Exclusion criteria

  • outborn child
  • premature newborn
  • newborn transferred

Treatment and study plan

instrumental delivery

Other

the birth was assisted with an extractor.

Primary outcomes

  1. Head mark or injury

    Time frame: 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)

  2. Newborn comfort

    Time frame: 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 outcomes

  1. Analgesic use

    Time frame: 0 to 72 hours of age

    Any analgesic administration to the newborn will be reported

  2. Length of hospitalisation after childbirth

    Time frame: First month of life

    The day out for home of the newborn will be reported

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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