NCT05894785

Brief Summary

In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 27, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

3.8 years

First QC Date

May 29, 2023

Last Update Submit

April 17, 2024

Conditions

Twin Pregnancy With Antenatal Problem

Outcome Measures

Primary Outcomes (1)

  • Success rates of ECV

    1 day

Secondary Outcomes (1)

  • Maternal and fetal morbidities

    up to 7 days from enrollment

Study Arms (1)

Study group

EXPERIMENTAL
Procedure: External cephalic version

Interventions

External cephalic versionPROCEDURE

An ECV attempt is made on the study group

Study group

Eligibility Criteria

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

You may qualify if:

  • years old or older multiparous no previous cesarean delivery (CD) a non-vertex presenting twin in a term (37 weeks gestation and onwards) dichorionic diamniotic twin pregnancy

You may not qualify if:

  • contraindication for a vaginal delivery nulliparous monochorionic diamniotic pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

MeSH Terms

Interventions

Version, Fetal

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Zvi Ehrlich

CONTACT

+9726555562ehrlichz@szmc.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 8, 2023

Study Start

February 27, 2022

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

IL(1)