Breech Presentation, External Cephalic Version
Conditions
Keywords
Breech, Version
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.
Interventions
DEVICEFetal Pillow insertion
Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Investigators and participants will not know whether participants have undergone inflation of the balloon device.
Intervention model description
Randomized trial using control and interventional arms.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having Successful Conversion to Cephalic Presentation | Immediately upon completion of the ECV procedure | Successful conversion of breech fetus to cephalic presentation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Presentation at Time of Delivery | Labor and Delivery (approximately 12 hours) | Cephalic presentation of the fetus during participant delivery |
| Cost of ECV Procedure and Hospital Stay (Mother) | ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days) | Cost of ECV procedure and hospital stay (mother) |
| Cost of ECV Procedure and Hospital Stay (Neonate) | Birth to hospital discharge (up to 42 days) | Cost of neonate's hospitalization after delivery |
| Shoulder Dystocia | Labor and Delivery (approximately 12 hours) | Presence of shoulder dystocia during delivery |
| Rupture of Membranes | Within 1 hour of ECV procedure | Presence of rupture of membranes after ECV procedure |
| Emergency Cesarean Delivery | During or within 1 hour of performing ECV procedure | Need for emergency cesarean delivery during or after ECV procedure |
| Cesarean Delivery | Immediately after ECV procedure or during subsequent labor and delivery | Presence of cesarean delivery |
| Procedural Pain During Device Insertion | Within 2 minutes after insertion of balloon device. | Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain). |
| Number of Attempts | Immediately after ECV procedure | Number of attempted ECV procedures to convert fetus from breech to cephalic presentation |
| Cost of Hospital Stay for ECV Procedure | 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 |
| Procedural Pain Prior to Device Insertion. | Within 3 minutes prior to insertion of device. | Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain). |
| Procedural Pain After Inflation of Device or Sham Inflation. | Within 1 minute after device inflation or sham inflation. | Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain). |
| Pain After External Cephalic Version Attempt. | Within 2 minutes of ECV procedure completion. | Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain). |
| Pelvic Hematoma | During or within 1 hour of performing ECV procedure | Development of a pelvic hematoma within 1 hour of ECV procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Non-inflation of the balloon device
Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure | 6 |
| Intervention Inflation of the balloon device
Fetal Pillow insertion: Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 5.1 | 30.5 years STANDARD_DEVIATION 6.2 | 28.6 years STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 |
Outcome results
Primary
Number of Participants Having Successful Conversion to Cephalic Presentation
Successful conversion of breech fetus to cephalic presentation
Time frame: Immediately upon completion of the ECV procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Having Successful Conversion to Cephalic Presentation | 3 Participants |
| Intervention | Number of Participants Having Successful Conversion to Cephalic Presentation | 2 Participants |
Secondary
Cesarean Delivery
Presence of cesarean delivery
Time frame: Immediately after ECV procedure or during subsequent labor and delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Cesarean Delivery | 0 Participants |
| Intervention | Cesarean Delivery | 0 Participants |
Secondary
Cost of ECV Procedure and Hospital Stay (Mother)
Cost of ECV procedure and hospital stay (mother)
Time frame: ECV procedure and during labor, delivery, and immediate postpartum period (up to 42 days)
Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.
Secondary
Cost of ECV Procedure and Hospital Stay (Neonate)
Cost of neonate's hospitalization after delivery
Time frame: Birth to hospital discharge (up to 42 days)
Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.
Secondary
Cost of Hospital Stay for ECV Procedure
Total cost of the hospital stay for the ECV procedure
Time frame: Patient arrival to labor unit for ECV procedure and discharge home (up to 72 hours)
Population: Data were not collected for this outcome because of multiple changes to the electronic medical record platforms during the study period and loss of analytics team resources that preclude analysis. There is no possibility of data collection for this secondary outcome.
Secondary
Emergency Cesarean Delivery
Need for emergency cesarean delivery during or after ECV procedure
Time frame: During or within 1 hour of performing ECV procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Emergency Cesarean Delivery | 0 Participants |
| Intervention | Emergency Cesarean Delivery | 0 Participants |
Secondary
Fetal Presentation at Time of Delivery
Cephalic presentation of the fetus during participant delivery
Time frame: Labor and Delivery (approximately 12 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Fetal Presentation at Time of Delivery | 3 Participants |
| Intervention | Fetal Presentation at Time of Delivery | 3 Participants |
Secondary
Number of Attempts
Number of attempted ECV procedures to convert fetus from breech to cephalic presentation
Time frame: Immediately after ECV procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Attempts | 2.3 Number of attempts | Standard Deviation 1.4 |
| Intervention | Number of Attempts | 2.6 Number of attempts | Standard Deviation 1.5 |
Secondary
Pain After External Cephalic Version Attempt.
Visual analogue pain score after ECV procedure (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 2 minutes of ECV procedure completion.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Pain After External Cephalic Version Attempt. | 38.7 units on a scale |
| Intervention | Pain After External Cephalic Version Attempt. | 29.2 units on a scale |
Secondary
Pelvic Hematoma
Development of a pelvic hematoma within 1 hour of ECV procedure
Time frame: During or within 1 hour of performing ECV procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Pelvic Hematoma | 0 Participants |
| Intervention | Pelvic Hematoma | 0 Participants |
Secondary
Procedural Pain After Inflation of Device or Sham Inflation.
Visual analogue pain score after inflation or sham inflation of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 1 minute after device inflation or sham inflation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Procedural Pain After Inflation of Device or Sham Inflation. | 22 units on a scale |
| Intervention | Procedural Pain After Inflation of Device or Sham Inflation. | 31 units on a scale |
Secondary
Procedural Pain During Device Insertion
Visual analogue pain score after insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 2 minutes after insertion of balloon device.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Procedural Pain During Device Insertion | 29 units on a scale |
| Intervention | Procedural Pain During Device Insertion | 59.6 units on a scale |
Secondary
Procedural Pain Prior to Device Insertion.
Baseline visual analogue pain score prior to insertion of balloon device (100mm visual analogue scale where 0 =no pain and 100=extreme pain).
Time frame: Within 3 minutes prior to insertion of device.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Procedural Pain Prior to Device Insertion. | 4.8 units on a scale |
| Intervention | Procedural Pain Prior to Device Insertion. | 10.4 units on a scale |
Secondary
Rupture of Membranes
Presence of rupture of membranes after ECV procedure
Time frame: Within 1 hour of ECV procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Rupture of Membranes | 0 Participants |
| Intervention | Rupture of Membranes | 0 Participants |
Secondary
Shoulder Dystocia
Presence of shoulder dystocia during delivery
Time frame: Labor and Delivery (approximately 12 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Shoulder Dystocia | 0 Participants |
| Intervention | Shoulder Dystocia | 0 Participants |