Elevation of the Fetal Buttocks Prior to External Cephalic Version

Breech Presentation Clinical Trial

Official title:

Elevation of the Fetal Buttocks Prior to External Cephalic Version

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04538261
• Other study ID #: 1379199
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients meeting inclusion criteria will be offered participation in this study. After performing an obstetric sonogram to determine fetal position, amniotic fluid status, fetal weight and placental location, the patient will be randomized to either placement of the Fetal Pillow balloon device with sham inflation (control arm) or placement of the device with inflation (study arm).

The researcher will show the patient the device, open the sterile container, and insert the device into the vagina per manufacturer's guidelines for all patients in the study. All patients will mark a line on a 100mm VAS to assess pre-insertion and post-insertion pain. The study physician will then obtain the assistance of a certified nurse midwife to inflate the device or perform a sham inflation. In order for the physician investigator to remain blinded, the physician will leave the room during the time of the inflation/sham inflation. A certified nurse midwife previously trained to inflate the device will perform the inflation or sham inflation per randomization. The assisting midwife will inflate the device with 180 mL of saline for those patients randomized to inflation. This will occur under a sheet so that the patient is blinded to the randomization scheme. If the patient is randomized to no inflation, the midwife will perform a sham inflation, also under a sheet. All patients will mark a line on a 100mm VAS to assess post-inflation/sham inflation pain. The assisting midwife then leaves the room, and the study physician reenters the room and proceeds with the external cephalic version (ECV) procedure.

Regardless of randomization, at this point the ECV procedure proceeds using normal routine. The ECV will be attempted up to four times and VAS will be assessed after each attempt. Once completed, all patients will also mark a line on a 100mm VAS to assess post-ECV pain.

The research physician will then remove the Fetal Pillow. Regardless of randomization, the procedure is completed per the usual routine of fetal monitoring, assessing for rupture of membranes, labor or bleeding, discussing post-procedure care, then discharge home (or, less likely, admitting for either observation or delivery).

The researcher will fill out the ECV portion of the data collection form. Data are collected later for delivery outcomes and costs for the mother and neonate.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breech Presentation
• External Cephalic Version

Intervention

Device:
• Fetal Pillow insertion
Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure

Locations

Country	Name	City	State
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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)