Neonatal Outcomes in Instrumental Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Instrumental Delivery; Nec, Affecting Fetus or Newborn
• Intervention / Treatment: Other: instrumental delivery

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Poitiers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 hours to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mature newborns who profit an instrumental delivery or not.

Description

Inclusion Criteria:

• term infant
• non-opposition of the newborn parent

Exclusion Criteria:

• outborn child
• premature newborn
• newborn transferred

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; newborns who were delivered with an extractor	Other: instrumental delivery; the birth was assisted with an extractor.
Controls; newborns who were not delivered with an extractor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	12 to 72 hours of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic use	Any analgesic administration to the newborn will be reported	0 to 72 hours of age
Length of hospitalisation after childbirth	The day out for home of the newborn will be reported	First month of life

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CNEI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No