Interventional procedure overview of balloon disimpaction of the baby's head at emergency caesarean
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Description of the procedure
Indications and current treatment
When the fetal head is impacted, a caesarean carries considerably increased risks. Delivery of the baby can be difficult if the head is impacted deep within the pelvis.
Two approaches are commonly used to disimpact an engaged baby's head. One involves the surgeon or an assistant placing fingers through the vagina and pushing the baby's head back up the pelvis. This can be associated with vaginal tissue trauma. The other approach (reverse breech extraction) involves the surgeon delivering the baby's feet first through the uterine incision, and then delivering the head. This method can be associated with hip injury, shoulder injury and facial or neck trauma for the baby and injury to the woman, and is avoided whenever possible. Difficulties in disimpacting a deeply engaged baby's head can delay the birth of a baby that is already at risk. There is a risk of the complications described above and also risks of obstetric haemorrhage, uterine tears, injury to uterine vessels and trauma to the urinary tract.
What the procedure involves
Balloon disimpaction of an engaged baby's head aims to elevate the head, without trauma. It is usually done immediately before an emergency caesarean done at full dilation.
A disposable soft silicone balloon device is inserted into the vagina, using a lubricant. The balloon is pushed posteriorly towards the coccyx and placed between the pelvic floor and the baby's head. The balloon surface is placed in contact with the head while the base plate of the device rests on the anococcygeal ligament to prevent downward displacement when the device is inflated. The procedure is similar to the placement of a ventouse cup. Once the device is in position, the balloon is inflated using sterile saline via a tube connected to a 2-way tap. The balloon is designed to inflate only in an upward direction. Inflating the balloon enables the engaged head to become elevated out of the pelvis by a few centimetres. The intention is to make the delivery easier with less manipulation through the abdominal wound and to reduce the risk of injury. Immediately after delivery the balloon is deflated by opening the 2-way tap, and the device is removed from the vagina by traction. Following the caesarean, the vagina is inspected for trauma.
Outcome measures
Apgar score
The Apgar score is used to assess the clinical status of newborn infants after delivery. The score has 5 components: skin colour, heart rate, reflexes, muscle tone, and respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and subsequently if needed.
Efficacy summary
Maternal outcomes
Uterine incision to delivery time
In a systematic review of 1,326 patients who had full dilation caesarean section with or without balloon disimpaction of the baby's head, the mean difference in uterine incision to delivery interval was -52.3 seconds (95% CI -55.2 to -34.94, p<0.001; 2 studies) when balloon disimpaction was used compared with when it was not used (Di Girolamo 2021).
In a randomised controlled trial of 50 patients, the uterine incision to delivery time was less than 2 minutes in 52% (13/25) of deliveries that used balloon disimpaction compared with 8% (2/25) of deliveries that used reverse breech extraction. None of the deliveries that used balloon disimpaction had an incision to delivery time of over 4 minutes, compared with 48% (12/25) of deliveries that used reverse breech extraction (p=0.04; Sengupta 2019).
Uterine incision extension
In the systematic review of 1,326 patients, the proportion of patients who had a uterine incision extension was statistically significantly lower when balloon disimpaction of the baby's head was used (pooled odds ratio 0.50, 95% CI 0.3 to 0.9; 6 studies, I2=68.6%; p=0.02; Di Girolamo 2021).
In a randomised controlled trial of 240 patients, which was included in the systematic review, the proportion of patients with grade 2 (increased operative time and blood loss) or grade 3 (into the cervix, vagina or bladder) uterine incision extensions was 5% (6/120) in the group with balloon disimpaction compared with 33% (39/120) in the group without balloon disimpaction (relative risk 0.23, 95% CI 0.11 to 0.48; Seal 2016).
In a randomised controlled trial of 60 patients who had caesarean delivery with an inflated or non-inflated balloon fetal head elevation device, also included in the systematic review, 20% (6/30) of those in the inflated group had a uterine incision extension compared with 43% (13/30) of those in the non-inflated group (p=0.05). The proportions of patients with grade 2 or 3 uterine incision extensions were 3% (1/30) and 37% (11/30) respectively (p=0.02; Lassey 2020).
In the randomised controlled trial of 50 patients, 8% (2/25) of patients who had balloon disimpaction had a uterine incision extension compared with 24% (6/25) of patients who had reverse breech extraction (p=0.001; Sengupta 2019).
Estimated blood loss and need for blood transfusion
In the systematic review of 1,326 patients, the mean estimated blood loss was statistically significantly lower in those who had balloon disimpaction of the baby's head during full dilation caesarean delivery compared with those who did not (mean difference -130.8 ml, 95% CI -130.1 to -381.0, p<0.001). There was no statistically significant difference in the proportion of patients with an estimated blood loss of more than 1,000 ml (pooled odds ratio 0.55, 95% CI 0.2 to 1.7, 4 studies, I2=81.6%, p=0.30). The proportion of patients who needed a blood transfusion was statistically significant lower in those who had balloon disimpaction of the baby's head (pooled odds ratio 0.39, 95% CI 0.2 to 0.7, 7 studies, I2=40.9%, p=0.04; Di Girolamo 2021).
In the randomised controlled trial of 50 patients, none of those who had balloon disimpaction needed a blood transfusion compared with 16% (4/25) of those who had reverse breech extraction (p=0.002; Sengupta 2019).
Operative complications
In the systematic review of 1,326 patients, the proportion of patients who had operative complications was statistically significantly lower when balloon disimpaction of the baby's head was used compared with when it was not used (pooled odds ratio 0.44, 95% CI 0.2 to 0.9; 3 studies, I2=5.7%; p=0.03; Di Girolamo 2021).
Length of hospital stay
In the systematic review of 1,326 patients, the mean length of hospital stay was statistically significantly shorter in those who had balloon disimpaction of the baby's head during full dilation caesarean delivery compared with those who did not (mean difference -0.88 days, 95% CI -1.07 to -0.70, p<0.001, 4 studies; Di Girolamo 2021).
Hospital readmission
In the systematic review of 1,326 patients, there was no statistically significant difference between the 2 groups in the proportion of patients who were readmitted to hospital (pooled odds ratio 0.98, 95% CI 0.3 to 2.9; 2 studies, I2=0%; p=0.97; Di Girolamo 2021).
Perinatal outcomes
Apgar score
In the systematic review of 1,326 patients there was no statistically significant difference between the 2 groups in the proportion of babies with an Apgar score below 3 at 1 minute (pooled odds ratio 0.41, 95% CI 0.03 to 4.4; 2 studies, I2=67.4%; p=0.47) or an Apgar score below 7 at 5 minutes (pooled odds ratio 1.01, 95% CI 0.5 to 1.9, 3 studies, I2=0%, p=0.97; Di Girolamo 2021).
Mean neonatal umbilical artery pH
In the systematic review of 1,326 patients, the mean neonatal umbilical artery pH was statistically significantly higher in those who had balloon disimpaction of the baby's head during full dilation caesarean delivery compared with those who did not (mean difference 0.62, 95% CI 0.43 to 0.88, p<0.001; 2 studies; Di Girolamo 2021).
Neonatal sepsis
In the systematic review of 1,326 patients, there was a lower proportion of neonatal sepsis in those who had balloon disimpaction of the baby's head during full dilation caesarean delivery compared with those who did not (pooled odds ratio 0.10, 95% CI 0.01 to 0.99, p=0.05, I2=0%, 2 studies; Di Girolamo 2021).
Admission to neonatal intensive care unit or special care baby unit
In the systematic review of 1,326 patients, there was a statistically significantly lower proportion of admissions to a neonatal intensive care unit in those who had balloon disimpaction of the baby's head during full dilation caesarean delivery compared with those who did not (pooled odds ratio 0.63, 95% CI 0.5 to 0.9, p=0.008, I2=0%, 6 studies; Di Girolamo 2021).
In the randomised controlled trial of 50 patients, 12% (3/25) of babies in the balloon disimpaction group were admitted to a special newborn care unit compared with 60% (15/25) of babies in the reverse breech extraction group (p=0.04; Sengupta 2019).
Need for endotracheal intubation
In the systematic review of 1,326 patients, the proportion of babies who needed endotracheal intubation was lower in those who had balloon disimpaction of the baby's head, but the difference between the groups was not statistically significant (pooled odds ratio 0.26, 95% CI 0.04 to 1.4, p=0.12, I2=0%, 3 studies; Di Girolamo 2021).
Neonatal death
In the systematic review of 1,326 patients, the proportion of neonatal deaths was lower in those who had balloon disimpaction of the baby's head but the difference between the groups was not statistically significant (pooled odds ratio 0.18, 95% CI 0.01 to 1.8, p=0.15, I2=0%, 2 studies; Di Girolamo 2021).
Safety summary
No adverse events directly related to the use of balloon fetal head elevation devices were reported.
Anecdotal and theoretical adverse events
In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).
For this procedure, professional experts described the following anecdotal adverse event: inadvertent deflation of the device before the birth of the baby, meaning elevation of the head may be suboptimal. They considered that the following were theoretical adverse events: infection, trauma to the genital tract or baby's head during device insertion or because of excessive pressure during device inflation.
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