Induction of Labor in Breech Presentation | NCT07071662

Studies
Induction of Labor in Breech Presentation

NCT07071662

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Mar 27, 2026Actual

Enrollment

102Actual

Phase

Not provided

Conditions

Labor Induction at Term
Failure
Breech Presentation at Term

Interventions

delivery mode

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Actual

Primary Completion Date

Oct 1, 2025Actual

Completion Date

Oct 1, 2025Actual

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 8, 2025

First Posted Date

Jul 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Breech presenting fœtus were generally not offered a trial labor induction and were instead directed toward a cesarean section. This approach often led to obstetric complications for both the mother and the fetus.

This study aims to offer more labor inductions to patients with a fetus in breech presentation in order to avoid the mobidity and mortality associated with systematic cesarean sections.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vaginal delivery			Other: delivery mode
caesarean			Other: delivery mode

Interventions

Name	Type	Description	Arm Group Labels	Other Names
delivery mode	Other	To observe the different modes of delivery and evaluate the characteristics of the patients as well as maternal and fetal well being in the post partum period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of vaginal delivery		day 1
Number of cesarean		day 1

Secondary Outcomes

Measure	Description	Time Frame
number of Endometrite		day 1
lactates value		day 1
Apgar value

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

34SA
singleton
consent for vaginal delivery
breech presenting

Exclusion Criteria:

-34SA
minor
twin pregnancy
refusal of vaginal delivery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with a fetus in breech presentation

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Amiens		Amiens		80480	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001946	Breech Presentation

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided