Breech Presentation Clinical Trial
— BREXITOfficial title:
Breech External Cephalic Version Intervention Trial- A Prospective Study
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 |
A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité University Hospital | Berlin-Mitte |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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
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 |
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