Breech External Cephalic Version Intervention Trial

Breech External Cephalic Version Intervention Trial- A Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03827226

Acronym

BREXIT

Enrollment

200

Registered

2019-02-01

Start date

2019-02-05

Completion date

2025-06-01

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Success rate of external cephalic version	4 hours after external cephalic version	Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,

Secondary

Measure	Time frame	Description
Fetal Doppler Indices middle cerebral	30 Minutes before external cephalic version	Index Measurements/Ratios
Sonographic Fetal Parameters: Head Circumference	30 Minutes before external cephalic version	Measurements in mm
Sonographic Fetal Parameters: Abdominal Circumference	30 Minutes before external cephalic version	Measurements in mm
Sonographic Fetal Parameters: Femur length	30 Minutes before external cephalic version	Measurements in mm
Fetal Doppler Indices Umbilical Pulsatility Index	30 Minutes before external cephalic version	Index Measurements/Ratios
Fetal Doppler Indices Umbilical Resistance Index	30 Minutes after external cephalic version	Index Measurements/Ratios
Maternal Doppler Indices Uterine artery Right	30 Minutes before external cephalic version	Index Measurements/Ratios
Maternal Doppler Indices Uterine artery Left	30 Minutes after external cephalic version	Index Measurements/Ratios
Bladder volume	30 Minutes before external cephalic version	Volume measurement
Distance Symphysis to Breech	30 Minutes before external cephalic version	mm
Sonographic Fetal Parameters: Amniotic Fluid	30 Minutes before external cephalic version	Measurements in mm
Fetal reflexes	30 Minutes before external cephalic version	Percentage
Mode of delivery	6 weeks after delivery	Type of delivery Vaginal or Caesarean
Incidence of fetal extended legs	30 Minutes before external cephalic version	Numerical percentage
Incidence of bleeding	30 minutes after external cephalic version	Numerical percentage
Incidence of ruptured membranes	30 minutes after external cephalic version	Numerical percentage
Incidence of pathological Cardiotocogram	30 minutes after external cephalic version	Numerical percentage
Incidence of emergency delivery	30 minutes after external cephalic version	Numerical percentage
Pain scores	30 minutes after external cephalic version	Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)
Incidence of tocolysis	30 minutes after external cephalic version	Numerical percentage
Incidence of umbilical cord looping	30 Minutes before external cephalic version	Numerical percentage
Depression and Anxiety Stress scale score	60 minutes before external cephalic version	A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)

Countries

Germany

Contacts

Primary ContactLarry Hinkson, FRCOG

Larry.Hinkson@charite.de0049 (0)30450564015

Outcome results