Neonatal Outcomes in Instrumental Delivery

NCT ID: NCT03337880

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-10-04

Brief Summary

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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.

Detailed Description

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Conditions

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Instrumental Delivery; Nec, Affecting Fetus or Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

newborns who were delivered with an extractor

instrumental delivery

Intervention Type OTHER

the birth was assisted with an extractor.

Controls

newborns who were not delivered with an extractor

No interventions assigned to this group

Interventions

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instrumental delivery

the birth was assisted with an extractor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* term infant
* non-opposition of the newborn parent

Exclusion Criteria

* outborn child
* premature newborn
* newborn transferred
Minimum Eligible Age

12 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poitiers University Hospital

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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CNEI

Identifier Type: -

Identifier Source: org_study_id

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