Instrumental Delivery; Nec, Affecting Fetus or NewbornNCT03337880
Neonatal Outcomes in Instrumental Delivery
An observational study of Instrumental Delivery; Nec, Affecting Fetus or Newborn, run by Poitiers University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 12 to 72 hours
- Conditions the study is for
- Instrumental Delivery; Nec, Affecting Fetus or Newborn
- What is being tested?
- instrumental delivery
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2017to 4 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: mature newborns who profit an instrumental delivery or not.
Who may be able to join
- term infant
- non-opposition of the newborn parent
Who cannot join
- outborn child
- premature newborn
- newborn transferred
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- instrumental delivery
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrumental deliveryOther
the birth was assisted with an extractor.
| Study group | Role | What they receive |
|---|---|---|
| Cases | newborns who were delivered with an extractor Receives: Other: instrumental delivery | |
| Controls | newborns who were not delivered with an extractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 to 72 hours of age
Secondary outcomes (2)
Analgesic use
Any analgesic administration to the newborn will be reported
Measured: 0 to 72 hours of age
Length of hospitalisation after childbirth
The day out for home of the newborn will be reported
Measured: First month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start4 Dec 2017
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrumental Delivery; Nec, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337880
- Sponsor's protocol ID
- CNEI
- Status last verified
- Dec 2017
- First submitted
- 6 Nov 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Outcomes in Instrumental Delivery: Newborn Head Mark and Comfort.
- ClinicalTrials.gov ID
- NCT03337880
- Acronym / sponsor ID
- CNEI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: instrumental deliverynewborns who were delivered with an extractor |
| Controls | – | –newborns who were not delivered with an extractor |
Who may qualify
- Ages
- 12 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- mature newborns who profit an instrumental delivery or not.
Key inclusion criteria (2 listed)
- term infant
- non-opposition of the newborn parent
Key exclusion criteria (3 listed)
- outborn child
- premature newborn
- newborn transferred
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instrumental deliverythe birth was assisted with an extractor. | Other | Cases |
Primary outcome
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)
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)
2 secondary outcomes
Analgesic use
Time frame: 0 to 72 hours of age
Length of hospitalisation after childbirth
Time frame: First month of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Instrumental Delivery; Nec, Affecting Fetus or Newborn, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head mark or injury (time frame: 12 to 72 hours of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 31 Oct 2026.