Neonatal Outcomes in Instrumental Delivery

Instrumental Delivery; Nec, Affecting Fetus or Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337880
• Other study ID #: CNEI
• Status: Completed
• Start date: December 4, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: December 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

• term infant

• non-opposition of the newborn parent

Exclusion Criteria:

• outborn child

• premature newborn

• newborn transferred

Related Conditions & MeSH terms

• Instrumental Delivery; Nec, Affecting Fetus or Newborn

Intervention

Other:
• instrumental delivery
the birth was assisted with an extractor.

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Analgesic use	Any analgesic administration to the newborn will be reported	0 to 72 hours of age
Secondary	Length of hospitalisation after childbirth	The day out for home of the newborn will be reported	First month of life