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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03827226
Other study ID # EA2/241/18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 5, 2019
Est. completion date June 1, 2025

Study information

Verified date February 2024
Source Charite University, Berlin, Germany
Contact Larry Hinkson, FRCOG
Phone 0049 (0)30450564015
Email Larry.Hinkson@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité University Hospital Berlin-Mitte

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of external cephalic version Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants, 4 hours after external cephalic version
Secondary Sonographic Fetal Parameters: Head Circumference Measurements in mm 30 Minutes before external cephalic version
Secondary Sonographic Fetal Parameters: Abdominal Circumference Measurements in mm 30 Minutes before external cephalic version
Secondary Sonographic Fetal Parameters: Femur length Measurements in mm 30 Minutes before external cephalic version
Secondary Sonographic Fetal Parameters: Amniotic Fluid Measurements in mm 30 Minutes before external cephalic version
Secondary Fetal Doppler Indices middle cerebral Index Measurements/Ratios 30 Minutes before external cephalic version
Secondary Fetal Doppler Indices Umbilical Pulsatility Index Index Measurements/Ratios 30 Minutes before external cephalic version
Secondary Fetal Doppler Indices Umbilical Resistance Index Index Measurements/Ratios 30 Minutes after external cephalic version
Secondary Maternal Doppler Indices Uterine artery Right Index Measurements/Ratios 30 Minutes before external cephalic version
Secondary Maternal Doppler Indices Uterine artery Left Index Measurements/Ratios 30 Minutes after external cephalic version
Secondary Bladder volume Volume measurement 30 Minutes before external cephalic version
Secondary Distance Symphysis to Breech mm 30 Minutes before external cephalic version
Secondary Depression and Anxiety Stress scale score A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe) 60 minutes before external cephalic version
Secondary Depression and Anxiety Stress scale score A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe) 120 Minutes after external cephalic version
Secondary Fetal reflexes Percentage 30 Minutes before external cephalic version
Secondary Mode of delivery Type of delivery Vaginal or Caesarean 6 weeks after delivery
Secondary Incidence of fetal extended legs Numerical percentage 30 Minutes before external cephalic version
Secondary Incidence of bleeding Numerical percentage 30 minutes after external cephalic version
Secondary Incidence of ruptured membranes Numerical percentage 30 minutes after external cephalic version
Secondary Incidence of pathological Cardiotocogram Numerical percentage 30 minutes after external cephalic version
Secondary Incidence of emergency delivery Numerical percentage 30 minutes after external cephalic version
Secondary Pain scores Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful) 30 minutes after external cephalic version
Secondary Incidence of tocolysis Numerical percentage 30 minutes after external cephalic version
Secondary Incidence of umbilical cord looping Numerical percentage 30 Minutes before external cephalic version
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT01922453 - Music and Sounds for ECV N/A
Completed NCT00516555 - EBIS: The Eindhoven Breech Intervention Study N/A
Completed NCT01487590 - Cephalic Version by Acupuncture-Moxibustion for Breech Presentation N/A
Completed NCT00890474 - Moxibustion for Fetus in Breech Presentation Phase 3
Terminated NCT00119184 - Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version Phase 1
Completed NCT05827627 - Simulation Techniques Used in Breech Birth Management Training N/A
Terminated NCT04538261 - Elevation of the Fetal Buttocks Prior to External Cephalic Version N/A
Recruiting NCT02801201 - Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation Phase 3
Completed NCT02331160 - Rebozo and External Cephalic Version in Breech Presentation. N/A
Completed NCT00901758 - Intravenous (IV) Nitroglycerin for Versions in Multiparous Women N/A
Completed NCT00896311 - Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women N/A
Not yet recruiting NCT02167841 - Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation. N/A
Completed NCT01048398 - Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions. Phase 3
Recruiting NCT04613778 - Correction of Breech Presentation With Laser Acupuncture N/A
Completed NCT01708018 - Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy N/A
Terminated NCT00465712 - Effect of Amnioinfusion on External Cephalic Version Successful Rate N/A
Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
Recruiting NCT06187948 - An Informative Video Before Planned External Cephalic Version N/A
Completed NCT00141687 - Early External Cephalic Version (ECV) 2 Trial N/A