Clinical trial NCT03827226: Breech External Cephalic Version Intervention Trial
Official title: Breech External Cephalic Version Intervention Trial- A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breech Presentation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with breech presentation to the antenatal clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of external cephalic version
timeFrame: 4 hours after external cephalic version
Secondary outcomes:
measure: Sonographic Fetal Parameters: Head Circumference
timeFrame: 30 Minutes before external cephalic version
measure: Sonographic Fetal Parameters: Abdominal Circumference
timeFrame: 30 Minutes before external cephalic version
measure: Sonographic Fetal Parameters: Femur length
timeFrame: 30 Minutes before external cephalic version
measure: Sonographic Fetal Parameters: Amniotic Fluid
timeFrame: 30 Minutes before external cephalic version
measure: Fetal Doppler Indices middle cerebral
timeFrame: 30 Minutes before external cephalic version
measure: Fetal Doppler Indices Umbilical Pulsatility Index
timeFrame: 30 Minutes before external cephalic version
measure: Fetal Doppler Indices Umbilical Resistance Index
timeFrame: 30 Minutes after external cephalic version
measure: Maternal Doppler Indices Uterine artery Right
timeFrame: 30 Minutes before external cephalic version
measure: Maternal Doppler Indices Uterine artery Left
timeFrame: 30 Minutes after external cephalic version
measure: Bladder volume
timeFrame: 30 Minutes before external cephalic version
measure: Distance Symphysis to Breech
timeFrame: 30 Minutes before external cephalic version
measure: Depression and Anxiety Stress scale score
timeFrame: 60 minutes before external cephalic version
measure: Depression and Anxiety Stress scale score
timeFrame: 120 Minutes after external cephalic version
measure: Fetal reflexes
timeFrame: 30 Minutes before external cephalic version
measure: Mode of delivery
timeFrame: 6 weeks after delivery
measure: Incidence of fetal extended legs
timeFrame: 30 Minutes before external cephalic version
measure: Incidence of bleeding
timeFrame: 30 minutes after external cephalic version
measure: Incidence of ruptured membranes
timeFrame: 30 minutes after external cephalic version
measure: Incidence of pathological Cardiotocogram
timeFrame: 30 minutes after external cephalic version
measure: Incidence of emergency delivery
timeFrame: 30 minutes after external cephalic version
measure: Pain scores
timeFrame: 30 minutes after external cephalic version
measure: Incidence of tocolysis
timeFrame: 30 minutes after external cephalic version
measure: Incidence of umbilical cord looping
timeFrame: 30 Minutes before external cephalic version
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité University Hospital
Study officials:
affiliation: Consultant in Obstetrics
name: Larry Hinkson, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.
citation: 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.
citation: 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.
citation: 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.