Trendelenburg Positioning and External Cephalic Version O... | NCT04585256

Studies
Trendelenburg Positioning and External Cephalic Version Outcome

NCT04585256

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Jan 25, 2023Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Breech Presentation of Fetus With Successful Version

Interventions

Trendelenburg positioning

Countries

Israel

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 6, 2020

First Submission Date that Met QC Criteria

Oct 12, 2020

First Posted Date

Oct 14, 2020Actual

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

Jan 21, 2023

Last Update Posted Date

Jan 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

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

Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.

Detailed Description

This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.

The women that are eligible for participation will receive a thorough explanation and will sign informed consent.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trendelenburg	Active Comparator	Women positioned in the trendelenburg position during external cephalic version.	Other: Trendelenburg positioning
Control	No Intervention	Women positioned on their back during external cephalic version.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trendelenburg positioning	Other	Women positioned in the trendelenburg position prior to external cephalic version	Trendelenburg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
External cephalic version success	The rate of successful external cephalic version	Up to 10 minutes from the beginning of external cephalic version.

Secondary Outcomes

Measure	Description	Time Frame
Pain	Visual analog scale scoring from 0-10 during and following the procedure.	Up to 2 hours from the beginning of external cephalic version.
Placental abruption	Rate of clinical placental abruption

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women interested in having external cephalic version at a gestational age of 37+0/7 or more.

Exclusion Criteria:

Age 18 and under.
Women with a body mass index 35 or higher.
Women with a previous cesarean section.
Women with premature rupture of membranes.
Women with vaginal bleeding.
Women with a previously failed external cephalic version.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roy Lauterbach, MD	Contact	+972-52-9432416		r_lauterbach@rmc.gov.il

Overall Officials

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam healthcare campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam health care campus	Recruiting	Haifa			Israel

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

Intervention Browse Module

MeSH Terms

ID	Term
D018475	Head-Down Tilt

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided