Breech Presentation Clinical Trial
Official title:
Elevation of the Fetal Buttocks Prior to External Cephalic Version
Verified date | February 2023 |
Source | AdventHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon device (Fetal Pillow) to elevate the fetal buttocks during external cephalic version procedures. Eligible study population: nulliparous pregnant women between 37-40 weeks estimated gestational age with a breech presenting fetus and no contraindications to external cephalic version.
Status | Terminated |
Enrollment | 11 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Women delivering at AdventHealth Orlando campus. 2. Breech presenting part as diagnosed by bedside sonography. 3. No prior deliveries >/= 20 weeks gestational age. 4. Pregnancy is between 37-40 weeks gestational age. 5. Live fetus. 6. Patient is >/= age 18. 7. Patient speaks English or Spanish as primary language. 8. Patient able to understand verbal and written consent Exclusion Criteria: 1. Non-breech presentation (cephalic, transverse, oblique). 2. More than 1 fetus. 3. Cervical dilation of >/= 1cm. 4. Prior uterine incision. 5. Congenital uterine anomaly. 6. Body mass index more than 40 kg/m2. 7. Uterine fibroids causing soft tissue dystocia. 8. Extended fetal neck. 9. Oligohydramnios (4-quadrant amniotic fluid index </= 5cm). 10. Spontaneous rupture of membranes. 11. Any contraindication to vaginal delivery. 12. Intrauterine growth restriction (estimated fetal weight </= 10%ile). 13. Estimated fetal weight > /= 5,000 grams for non-diabetic patient or >/= 4,500 grams for patient with pre-existing or gestational diabetes, confirmed by ultrasound. 14. Fetal gastroschisis. 15. Fetal neural tube defect. 16. Severe-range preeclampsia. 17. Patient had regional anesthesia immediately prior to ECV. |
Country | Name | City | State |
---|---|---|---|
United States | AdventHealth Orlando | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
AdventHealth |
United States,
External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837. — View Citation
Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3. — View Citation
Kok M, Cnossen J, Gravendeel L, van der Post J, Opmeer B, Mol BW. Clinical factors to predict the outcome of external cephalic version: a metaanalysis. Am J Obstet Gynecol. 2008 Dec;199(6):630.e1-7; discussion e1-5. doi: 10.1016/j.ajog.2008.03.008. Epub 2 — View Citation
Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j — View Citation
Weiniger CF, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful external cephalic version | Successful conversion of breech fetus to cephalic presentation | Immediately upon completion of the ECV procedure | |
Secondary | Cesarean delivery | Presence of cesarean delivery | Immediately after ECV procedure or during subsequent labor and delivery | |
Secondary | Fetal presentation at time of delivery | Presentation of the fetus during participant delivery | Labor and Delivery (approximately 12 hours) | |
Secondary | Cost of ECV procedure and hospital stay (mother) | Total cost of hospital stay for mother | ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days) | |
Secondary | Cost of ECV procedure and hospital stay (neonate) | Cost of neonate's hospitalization after delivery | Birth to hospital discharge (up to 42 days) | |
Secondary | Shoulder dystocia | Presence of shoulder dystocia during delivery | Labor and Delivery (approximately 12 hours) | |
Secondary | Rupture of membranes | Presence of rupture of membranes after ECV procedure | Within 1 hour of ECV procedure | |
Secondary | Emergency cesarean delivery | Need for emergency cesarean delivery during or after ECV procedure | During or within 1 hour of performing ECV procedure | |
Secondary | Pelvic hematoma | Development of a pelvic hematoma within 1 hour of ECV procedure | During or within 1 hour of performing ECV procedure | |
Secondary | Procedural pain | Visual analogue pain score prior to during and after ECV procedure (100mm visual analogue scale where 0 =no pain and 10=extreme pain). | Immediately before, during, and within 2 minutes after completing the ECV procedure | |
Secondary | Number of attempts | Number of attempted ECV procedures to convert fetus from breech to cephalic presentation | During and immediately after ECV procedure | |
Secondary | Cost of hospital stay for ECV procedure | Total cost of the hospital stay for the ECV procedure | Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours) |
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