- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03337880
Neonatal Outcomes in Instrumental Delivery
January 28, 2019 updated by: Poitiers University Hospital
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Poitiers, France, 86000
- Poitiers university hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cases
newborns who were delivered with an extractor
|
the birth was assisted with an extractor.
|
Controls
newborns who were not delivered with an extractor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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12 to 72 hours of age
|
Newborn comfort
Time Frame: 12 to 72 hours of age
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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
Time Frame: 0 to 72 hours of age
|
Any analgesic administration to the newborn will be reported
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0 to 72 hours of age
|
Length of hospitalisation after childbirth
Time Frame: First month of life
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The day out for home of the newborn will be reported
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First month of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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