Breech External Cephalic Version Intervention Trial

NCT ID: NCT03827226

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-05

Study Completion Date

2025-06-01

Brief Summary

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

Detailed Description

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The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.

Conditions

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Breech Presentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age under 18
* Limited ability to consent
* Placenta previa
* Fetal abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Larry Hinkson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry Hinkson, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Consultant in Obstetrics

Locations

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Charité University Hospital

Mitte, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Larry Hinkson, FRCOG

Role: CONTACT

0049 (0)30450564015

Facility Contacts

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Larry Hinkson, FRCOG

Role: primary

References

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Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.

Reference Type BACKGROUND
PMID: 10796122 (View on PubMed)

American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312.

Reference Type RESULT
PMID: 26942387 (View on PubMed)

External Cephalic Version and Reducing the Incidence of Term Breech Presentation: Green-top Guideline No. 20a. BJOG. 2017 Jun;124(7):e178-e192. doi: 10.1111/1471-0528.14466. Epub 2017 Mar 16. No abstract available.

Reference Type RESULT
PMID: 28299867 (View on PubMed)

Schauer M, Latartara E, Alonso-Espias M, Rossetti E, Gebert P, Henrich W, Hinkson L. Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study. Arch Gynecol Obstet. 2023 Feb;307(2):409-419. doi: 10.1007/s00404-022-06509-0. Epub 2022 Mar 27.

Reference Type DERIVED
PMID: 35344082 (View on PubMed)

Other Identifiers

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EA2/241/18

Identifier Type: -

Identifier Source: org_study_id

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