Clinical trial NCT04538261: Elevation of the Fetal Buttocks Prior to External Cephalic Version
Official title: Elevation of the Fetal Buttocks Prior to External Cephalic Version
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breech Presentation
External Cephalic Version
Keywords: Breech
Version
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial using control and interventional arms.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Having Successful Conversion to Cephalic Presentation
timeFrame: Immediately upon completion of the ECV procedure
Secondary outcomes:
measure: Cesarean Delivery
timeFrame: Immediately after ECV procedure or during subsequent labor and delivery
measure: Fetal Presentation at Time of Delivery
timeFrame: Labor and Delivery (approximately 12 hours)
measure: Cost of ECV Procedure and Hospital Stay (Mother)
timeFrame: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)
measure: Cost of ECV Procedure and Hospital Stay (Neonate)
timeFrame: Birth to hospital discharge (up to 42 days)
measure: Shoulder Dystocia
timeFrame: Labor and Delivery (approximately 12 hours)
measure: Rupture of Membranes
timeFrame: Within 1 hour of ECV procedure
measure: Emergency Cesarean Delivery
timeFrame: During or within 1 hour of performing ECV procedure
measure: Pelvic Hematoma
timeFrame: During or within 1 hour of performing ECV procedure
measure: Procedural Pain During Device Insertion
timeFrame: Within 2 minutes after insertion of balloon device.
measure: Number of Attempts
timeFrame: Immediately after ECV procedure
measure: Cost of Hospital Stay for ECV Procedure
timeFrame: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)
measure: Procedural Pain Prior to Device Insertion.
timeFrame: Within 3 minutes prior to insertion of device.
measure: Procedural Pain After Inflation of Device or Sham Inflation.
timeFrame: Within 1 minute after device inflation or sham inflation.
measure: Pain After External Cephalic Version Attempt.
timeFrame: Within 2 minutes of ECV procedure completion.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth
name: David A Hill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth
name: Ariana Mora
role: STUDY_DIRECTOR
References:
citation: External Cephalic Version: ACOG Practice Bulletin, Number 221. Obstet Gynecol. 2020 May;135(5):e203-e212. doi: 10.1097/AOG.0000000000003837.
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.ijgo.2015.09.019. Epub 2016 Jan 15.
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.
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 2008 May 23.
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: 10.1097/01.AOG.0000295605.38175.7b.