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Elevation of the Fetal Buttocks Prior to External Cephalic Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04538261
Recruitment Status : Terminated (Not recruiting at the rate we thought it would.)
First Posted : September 4, 2020
Last Update Posted : February 2, 2023
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Breech Presentation External Cephalic Version Device: Fetal Pillow insertion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial using control and interventional arms.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Investigators and participants will not know whether participants have undergone inflation of the balloon device.
Primary Purpose: Treatment
Official Title: Elevation of the Fetal Buttocks Prior to External Cephalic Version
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : January 31, 2023
Actual Study Completion Date : January 31, 2023

Arm Intervention/treatment
Sham Comparator: Control
Non-inflation of the balloon device
Device: Fetal Pillow insertion
Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure

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

Primary Outcome Measures :
  1. Successful external cephalic version [ Time Frame: Immediately upon completion of the ECV procedure ]
    Successful conversion of breech fetus to cephalic presentation

Secondary Outcome Measures :
  1. Cesarean delivery [ Time Frame: Immediately after ECV procedure or during subsequent labor and delivery ]
    Presence of cesarean delivery

  2. Fetal presentation at time of delivery [ Time Frame: Labor and Delivery (approximately 12 hours) ]
    Presentation of the fetus during participant delivery

  3. Cost of ECV procedure and hospital stay (mother) [ Time Frame: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days) ]
    Total cost of hospital stay for mother

  4. Cost of ECV procedure and hospital stay (neonate) [ Time Frame: Birth to hospital discharge (up to 42 days) ]
    Cost of neonate's hospitalization after delivery

  5. Shoulder dystocia [ Time Frame: Labor and Delivery (approximately 12 hours) ]
    Presence of shoulder dystocia during delivery

  6. Rupture of membranes [ Time Frame: Within 1 hour of ECV procedure ]
    Presence of rupture of membranes after ECV procedure

  7. Emergency cesarean delivery [ Time Frame: During or within 1 hour of performing ECV procedure ]
    Need for emergency cesarean delivery during or after ECV procedure

  8. Pelvic hematoma [ Time Frame: During or within 1 hour of performing ECV procedure ]
    Development of a pelvic hematoma within 1 hour of ECV procedure

  9. Procedural pain [ Time Frame: Immediately before, during, and within 2 minutes after completing the ECV procedure ]
    Visual analogue pain score prior to during and after ECV procedure (100mm visual analogue scale where 0 =no pain and 10=extreme pain).

  10. Number of attempts [ Time Frame: During and immediately after ECV procedure ]
    Number of attempted ECV procedures to convert fetus from breech to cephalic presentation

  11. Cost of hospital stay for ECV procedure [ Time Frame: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours) ]
    Total cost of the hospital stay for the ECV procedure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04538261

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United States, Florida
AdventHealth Orlando
Orlando, Florida, United States, 32804
Sponsors and Collaborators
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Principal Investigator: David A Hill, MD AdventHealth
Study Director: Ariana Mora AdventHealth
Publications of Results:
Other Publications:
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Responsible Party: AdventHealth Identifier: NCT04538261    
Other Study ID Numbers: 1379199
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared outside of research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AdventHealth:
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases