NCT04771091

Brief Summary

In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2021

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

February 22, 2021

Last Update Submit

April 11, 2023

Conditions

PregnanciesObstetric Labor

Keywords

Head perineum distanceultrasound measuredelivery modeinstrumental deliveryspontaneous deliverypushing maternal efforts

Outcome Measures

Primary Outcomes (1)

  • Delivery mode

    spontaneous or instrumental vaginal delivery

    Day 1

Study Arms (1)

Mesure of head-perineum distance by transperineal ultrasound

EXPERIMENTAL

A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist.

Diagnostic Test: Mesure of head-perineum distance by transperineal ultrasound

Interventions

Mesure of head-perineum distance by transperineal ultrasoundDIAGNOSTIC_TEST

A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist

Also known as: Echography
Mesure of head-perineum distance by transperineal ultrasound

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single pregnancy
  • In labor (spontaneous or induced)
  • Term superior at 37 SA
  • Delivery by summit presentation

You may not qualify if:

  • Non single pregnancy
  • Suspected malformative abnormalities in the unborn fetus
  • Refusal of participation
  • Minor patient
  • Adult patient subject to legal protection or patient deprived of liberty
  • Poor French language understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maela Le Lous, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

July 8, 2020

Primary Completion

April 4, 2021

Study Completion

April 4, 2021

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)