NCT04579835

Brief Summary

A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Sep 2020

Longer than P75 for all trials

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 Progress93%
Sep 2020Sep 2026

First Submitted

Initial submission to the registry

September 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2026

Expected
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

September 28, 2020

Last Update Submit

February 5, 2024

Conditions

Breech PresentationTwin; Complicating Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Success rate of external cephalic version Twin A

    Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants

    4 hours after external cephalic version

Secondary Outcomes (10)

  • Fetal weight

    30 Minutes before external cephalic version

  • Fetal Doppler Umbilical Pulsatility Index

    30 Minutes before external cephalic version

  • Fetal Doppler Umbilical Resistance Index

    30 Minutes before external cephalic version

  • Incidence of pathological cardiotocogramm

    60 Minutes after external cephalic version

  • Incidence of emergency delivery

    60 Minutes after external cephalic version

  • +5 more secondary outcomes

Interventions

External Cephalic VersionOTHER

External Cephalic Version Twin A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting with Twin A breech presentation to the antenatal clinic

You may qualify if:

  • Presence of the written consent of the patients.
  • The patients must be over 18 years old .
  • No limit in the ability to consent.

You may not qualify if:

  • Age under 18
  • Limited ability to consent
  • Placenta previa
  • Fetal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Hospital

Mitte, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Breech PresentationPregnancy Complications

Interventions

Version, Fetal

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Larry Hinkson, FRCOG

    Charité University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Hinkson, FRCOG

CONTACT

004930450664710Larry.Hinkson@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Consultant in Obstetrics, Deputy Director

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

September 28, 2020

Primary Completion

September 28, 2025

Study Completion (Estimated)

September 28, 2026

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)