Interventional procedure overview of balloon disimpaction of the baby's head at emergency caesarean during the second stage of labour
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Evidence summary
Population and studies description
This interventional procedures overview is based on about 3,000 people included in studies on balloon disimpaction, from 1 systematic review (Cornthwaite 2024), 5 retrospective cohort studies (Sadler 2024, Sacre 2021, Hanley 2020, Chooi 2022, Safa 2016), 2 randomised controlled trials (Lassey 2020, Dutta 2019), 1 prospective non-randomised comparative study (Barman 2015) and 2 case reports (Jordan 2022, Mumtaz 2023). Both the randomised controlled trials and all the cohort studies except 1 (Sadler 2024) were also included in the systematic review. Of the 3,000 people included in the studies, 986 had the procedure. This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 11 studies as the key evidence in table 2 and table 3, and lists 7 other relevant studies in appendix B, table 5.
Studies were from Australia, India, New Zealand, UK and US. The systematic review included 24 studies, 7 of which used balloon disimpaction (Cornthwaite 2024). Of the 7 studies, 6 have been included in the key evidence tables to give details of all the reported outcomes. The remaining study was a non-randomised comparative study that has been retracted since the systematic review was prepared. The systematic review assessed certainty of evidence across outcomes using GRADE and avoided pooling data for meta-analysis when there was high heterogeneity. It excluded a randomised controlled trial that had been retracted because of concerns about scientific integrity. It used a sensitivity analysis that excluded the non-randomised study that has also since been retracted. According to GRADE criteria, the certainty of evidence was very low.
A recently published large retrospective cohort study in New Zealand compared outcomes within and between 2 centres (Sadler 2024). In 1 centre, outcomes were compared before and after the balloon disimpaction device was introduced and outcomes were compared with and without its use. The outcomes in this centre were then compared with the outcomes in a centre that didn't have the device available. The primary outcome was uterine incision extension. There were statistically significant differences in demographic and clinical characteristics between the comparison groups, including parity, fetal head station and attempted assisted vaginal birth, suggesting that balloon disimpaction was used for more difficult deliveries. There were statistically significant differences in maternal ethnicity between the comparison groups. In the unit where the balloon disimpaction device was available, there was a higher proportion of people of Indian ethnicity (33%) and a lower proportion of people of Maori ethnicity (11%) in the group where the device was used compared to the group in which the device was not used (26% Indian and 16% Maori). When the 2 units were compared, the unit with the balloon device had a higher proportion of people with a specific ethnicity recorded (14% Maori, 25% Pacific, 29% Indian, 11% other Asian and 22% 'Other') compared with the unit without the balloon device (5% Maori, 6% Pacific, 16% Indian, 25% other Asian, and 48% 'Other').
The 2 randomised controlled trials were both small and 1 was published in a journal that was identified in the systematic review as being 'potentially predatory' (Dutta 2019). This trial was based in India and compared balloon disimpaction (n=25) with the modified Patwardhan technique (n=25). Although the paper describes the trial as a prospective comparative trial rather than a randomised controlled trial in the title and methods, it does describe a process of randomising treatment allocation. The primary outcome measure was not specified. The trial by Lassey et al. (2020) was based in the US and compared outcomes in nulliparous women having caesarean delivery in the second stage of labour using an inflated balloon disimpaction device (n=30) with those using a non-inflated device (n=30). The study assessed the use of the device in the second stage of labour and did not specifically address its use with impacted fetal head. The original trial description stated the estimated enrolment was 200 but the actual enrolment was 60. The primary outcome measure was time (in seconds) from hysterotomy to delivery of the neonate.
The remaining 4 retrospective cohort studies were based in the UK and Australia. The study by Sacre et al. (2021) included 391 caesarean births, 170 (44%) of which used balloon disimpaction based on the individual clinician's decision. There were no statistically significant differences between the groups in maternal age, body mass index, ethnicity, onset of labour, or fetal position. Most of the women (87%) were described as Caucasian. The proportion of nulliparous women was higher in the balloon disimpaction group as was the proportion of fetal head station reported below the ischial spines. There was a higher number of deliveries for fetal distress in the group without balloon disimpaction. The study by Hanley et al. (2020) included 174 caesarean births, 114 (66%) of which used balloon disimpaction. There were no statistically significant differences in baseline characteristics between the groups. The primary outcome of interest was operative complications, which included uterine incision extension, need for breech extraction, use of vertical incision and bladder, ureter or bowel injury. The study by Chooi et al. (2023) included all caesarean births where balloon disimpaction was used (n=53) and randomly selected a similar number of caesarean births without balloon disimpaction (n=48). Maternal and neonatal baseline characteristics were similar between the 2 groups. The study by Safa et al. (2016) compared all caesarean births done at full dilation using balloon disimpaction with those using the hand-push technique to disimpact the fetal head. Maternal baseline characteristics were similar between the groups.
The prospective non-randomised comparative study by Barman et al. (2015) was not included in the systematic review by Cornthwaite et al. (2024). It compared 75 caesarean deliveries using balloon disimpaction with 72 deliveries using the Patwardhan technique. Assignment to each group was done alternately. Maternal baseline characteristics were similar between the groups.
The case report by Jordan et al. (2022) describes uterine and bladder rupture when balloon disimpaction was used at a full dilation caesarean in a woman who had had a previous caesarean delivery at full dilation for obstructed labour. The case report by Mumtaz et al. (2023) describes 2 cases of posterior uterine wall rupture identified at caesarean immediately after balloon disimpaction was used.
Table 2 presents study details.
Procedure technique
All studies used the Fetal Pillow (Safe Obstetrics Systems UK, now CooperSurgical) for balloon disimpaction at caesarean during the second stage of labour or at full dilation (1 study included some women who were not fully dilated; Chooi 2023).
Maternal outcomes
Uterine incision extension
Uterine incision extension or uterine angle extension was reported as an outcome in 7 studies. In the systematic review by Cornthwaite et al. (2024), the RR for uterine incision extension when balloon disimpaction was used compared with no balloon was 0.90 (95% CI 0.67 to 1.23, I2=0%) based on 3 studies (Chooi 2023, Hanley 2020 and Sacre 2021).
The study by Hanley et al. (2020) was a retrospective cohort of 173 caesarean deliveries with or without balloon disimpaction and the primary outcome was a composite measure of 'operative complications', including uterine incision extension, need for breech extraction, use of vertical incision and bladder, ureter or bowel injury. The rates for this outcome were 17% (19/114) in the balloon disimpaction group and 25% (15/60) in the control group (OR=0.56, 95% CI 0.26 to 1.22, p=0.146; Hanley 2020).
In the cohort study of 1,703 caesareans, the rate of uterine incision extension was 25% (219/883) after the balloon disimpaction device was introduced to the maternity unit compared with 27% (84/314) before (adjusted OR=0.88, 95% CI 0.65 to 1.19; Sadler 2024). For nulliparous women, the adjusted OR was 1.13 (95% CI 0.78 to 1.62) and for nulliparous women it was 0.47 (95% CI 0.26 to 0.82). After the device had been introduced to the maternity unit, the rate of uterine incision extension was 26% (98/375) when the device was used compared with 24% (121/508) when it wasn't used (adjusted OR 1.14, 95% CI 0.83 to 1.57). The rate of uterine incision extension in the unit with availability of the balloon disimpaction device was 24% (139/574) compared with 29% (148/506) in a unit without availability of the device (adjusted OR 0.73, 95% CI 0.54 to 0.99).
In the randomised controlled trial of 60 caesarean deliveries, the rate of uterine incision extension was 20% (6/30) when a balloon disimpaction device was used and inflated compared with 43% (13/30) when the device was not inflated (p=0.05). Of the 13 extensions in the non-inflated group, 4 were into the cervix, vagina or bladder compared with none in the inflated group (Lassey 2020). In the randomised controlled trial of 50 caesareans at full dilation with a deeply engaged fetal head, the rate of uterine incision extension was 8% in the balloon disimpaction group and 24% in the modified Patwardhan technique group (p=0.001; Dutta 2019).
In the retrospective cohort study of 160 caesarean deliveries, the rate of uterine angle extension was 20% (18/91) when balloon disimpaction was used and 35% (24/69) when a hand-push technique was used (p=0.061; Safa 2016).
In the prospective non-randomised comparative study of 147 caesarean deliveries, the rate of uterine angle extension was 25% (19/75) when balloon disimpaction was used and 18% (13/72) when the Patwardhan technique was used (p=0.285; Barman 2015).
Uterine wall rupture
Three cases of uterine wall rupture were described in 2 papers (Jordan 2022, Mumtaz 2023). In 1 woman, who had had a previous caesarean, the lower segment of the uterus ruptured into the bladder before the baby was delivered. The rupture was surgically repaired and the total maternal blood loss was 3.1 litres (Jordan 2022). In the 2 other women, 1 of whom had had a previous caesarean, there was a partial or full thickness uterine posterior wall rupture identified after the baby was delivered. These were repaired surgically and estimated blood loss was 1,000 ml and 1,300 ml respectively (Mumtaz 2023). In all 3 cases, the baby was delivered in good condition (Apgar scores 8 and above) and immediate and long-term recovery were uneventful.
Uterine artery tear
In the prospective non-randomised comparative study of 147 caesarean deliveries, the rate of uterine artery tear was 20% (15/75) when balloon disimpaction was used and 10% (7/72) when the Patwardhan technique was used (p=0.081; Barman 2015).
Bleeding
In the systematic review by Cornthwaite et al. (2024), the RR for postpartum haemorrhage (blood loss more than 1,000 ml) when balloon disimpaction was used compared with no balloon was 1.13 (95% CI 0.83 to 1.54, I2=0%) based on 3 studies (Chooi 2023, Hanley 2020 and Sacre 2021).
In the randomised controlled trial of 60 caesarean deliveries, the median blood loss was 800 ml when an inflated balloon disimpaction device was used compared with 900 ml when a non-inflated device was used (mean difference=‑191.7, p=0.09; Lassey 2020). In the randomised controlled trial of 50 caesareans at full dilation with a deeply engaged fetal head, the rate of blood transfusion was 0% in the balloon disimpaction group and 16% in the modified Patwardhan technique group (p=0.002; Dutta 2019).
In the retrospective cohort study of 160 caesarean deliveries, the mean estimated blood loss was 273 ml when balloon disimpaction was used and 403 ml when a hand-push technique was used (p=0.026). The rate of blood transfusion was 3% in both groups (Safa 2016).
In the prospective non-randomised comparative study of 147 caesarean deliveries, the rate of blood transfusion was 5% (4/75) when balloon disimpaction was used and 7% (5/72) when the Patwardhan technique was used (Barman 2015).
Operative time
In the randomised controlled trial of 60 caesarean deliveries, the median time from hysterotomy to delivery was 31 seconds when an inflated balloon disimpaction device was used compared with 54 seconds when a non-inflated device was used (mean difference=‑38.2 seconds, 95% CI -56.1 to -20.3, p<0.01; Lassey 2020). In the randomised controlled trial of 50 caesarean deliveries, the uterine incision to delivery time was 0 to 2 minutes in 52% of those who had balloon disimpaction and 8% of those who had modified Patwardhan technique, 2 to 4 minutes in 48% of those who had balloon disimpaction and 44% of those who had modified Patwardhan technique and 4 to 6 minutes in none of those who had balloon disimpaction and 48% of those who had modified Patwardhan technique (p=0.04; Dutta 2019).
In the prospective non-randomised comparative study of 147 caesarean deliveries, the mean baby delivery time was 180 seconds when balloon disimpaction was used and 270 seconds when the Patwardhan technique was used (p<0.0001). The mean total operative time (skin to skin) was 36.8 minutes in the balloon disimpaction group and 40.2 minutes in the Patwardhan technique group (p=0.004; Barman 2015).
Admission to high dependency unit
In the cohort study of 101 caesarean deliveries, the rate of admission to a high dependency unit was similar with or without balloon disimpaction (11% in the group with balloon disimpaction and 10% in the group without balloon disimpaction (p=0.88; Chooi 2023).
In the randomised controlled trial of 60 caesarean deliveries comparing the use of an inflated balloon disimpaction device with a non-inflated device, the authors stated that intensive care unit admission was a rare event and not different between the groups (Lassey 2020).
Length of hospital stay
In the retrospective cohort of 173 caesarean deliveries with or without balloon disimpaction, the mean length of stay was 65.8 hours in the balloon disimpaction group and 72.6 hours in the control group (p=0.71; Hanley 2020). In the cohort study of 101 caesarean deliveries, the mean length of stay was 3.22 days in the balloon disimpaction group and 3.45 in the control group (mean difference=-0.23, 95% CI -0.75 to 0.29, p=0.39; Chooi 2023). In the retrospective cohort study of 160 caesarean deliveries, the mean length of stay was 77.9 hours when balloon disimpaction was used and 97.8 hours when a hand-push technique was used (p=0.002; Safa 2016).
Ease of delivery
In the randomised controlled trial of 60 caesarean deliveries comparing the use of an inflated balloon disimpaction device with a non-inflated device, healthcare providers described 80% (24/30) of deliveries in the inflated group as 'easy' or 'very easy' compared with 43% (13/30) in the not-inflated group. None of the deliveries in the inflated group were described as 'difficult' or 'very difficult' compared with 37% (11/30) in the not-inflated group (p<0.01). 97% (29/30) of healthcare providers in the inflated group would use the balloon elevation device again or recommend it to others compared with 77% (22/30) in the not-inflated group (p=0.03; Lassey 2020).
In the prospective non-randomised comparative study of 147 caesareans, delivery of the fetal head was described as easy in 76% (57/75) of those in the balloon disimpaction group and 32% (23/72) of those in the Patwardhan technique group (OR=6.75, 95% CI 3.08 to 14.95; Barman 2015).
Neonatal outcomes
Neonatal trauma
Neonatal trauma (soft tissue injury, bony trauma or intracranial bleed) was reported in 30% (16/53) of babies in the balloon disimpaction group and 23% (11/47) of babies in the control group, in the cohort study of 101 caesarean deliveries (RR=1.29, 95% CI 0.67 to 2.59, p=0.45; Chooi 2023).
Apgar score at 5 minutes
In the systematic review by Cornthwaite et al. (2024), the RR for an Apgar score of less than 7 at 5 minutes when balloon disimpaction was used compared with no balloon was 1.01 (95% CI 0.84 to 1.21, I2=0%) based on 3 studies (Chooi 2023, Hanley 2020 and Sacre 2021).
In the randomised controlled trial of 60 caesarean deliveries comparing the use of an inflated balloon disimpaction device with a non-inflated device, the median Apgar score at 5 minutes was 9 in both groups (Lassey 2020).
In the retrospective cohort study of 160 caesarean deliveries, the proportion of babies with an Apgar score below 7 at 5 minutes was 3% (3/91) when balloon disimpaction was used and 6% (4/69) hours when a hand-push technique was used (p=0.44; Safa 2016).
In the prospective non-randomised comparative study of 147 caesarean deliveries, the mean Apgar score at 5 minutes was 7.79 in the balloon disimpaction group and 5.96 in the Patwardhan technique group (p<0.0001). Two babies in the Patwardhan technique group were stillborn (Barman 2015).
Admission to special care baby unit or neonatal intensive care unit
In the randomised controlled trial of 50 caesarean deliveries, 12% of babies in the balloon disimpaction group and 60% of those in the modified Patwardhantechnique group were admitted to a special newborn care unit (p=0.04; Dutta 2019). One of the babies in the modified Patwardhan group died on day 11.
None of the retrospective non-randomised comparative studies reported a statistically significant difference in the rate of admission to a special care baby unit or neonatal intensive care. In the cohort study of 391 caesarean deliveries, the rate of admission was 9% (15/170) in the balloon disimpaction group and 12% (27/221) in the control group (RR 0.72, 95% CI 0.40 to 1.31, p=0.29; Sacre 2021). In the cohort study of 173 caesarean deliveries with or without balloon disimpaction, 33% (37/112) of babies in the balloon disimpaction group had a stay in neonatal intensive care compared with 40% (24/60) in the control group (OR=0.76, 95% CI 0.39 to 1.47, p=0.41; Hanley 2020). The mean duration of stay was 1 hour in the balloon disimpaction group and 1.5 hours in the control group (p=0.24). In the cohort study of 101 caesarean deliveries, the rate of admission was 30% (16/53) in the balloon disimpaction group and 47% (22/47) in the control group (RR=0.64, 95% CI 0.38 to 1.07, p=0.09; Chooi 2023). In the retrospective cohort study of 160 caesarean deliveries, the rate of admission was 15% (14/91) when balloon disimpaction was used and 25% (17/69) when a hand-push technique was used (p=0.14; Safa 2016).
In the prospective non-randomised comparative study of 147 caesarean deliveries, the rate of admission to a neonatal intensive care unit was 17% (13/75) in the balloon disimpaction group and 33% (24/72) in the Patwardhan technique group (p<0.0001). Two babies in the Patwardhan technique group were stillborn (p=0.025).
Umbilical cord arterial pH
In the retrospective cohort study of 391 caesarean deliveries, umbilical cord arterial pH was less than 7.1 in 7% (12/170) of babies in the balloon disimpaction group and 13% (29/221) in the control group (RR 0.54, 95% CI 0.28 to 1.02, p=0.06; Sacre 2021). In the retrospective cohort of 173 caesarean deliveries with or without balloon disimpaction, the mean umbilical cord arterial pH was statistically significantly higher in the balloon disimpaction group (7.25) than in the control group (7.19; p=0.0001, Hanley 2020). In the cohort study of 101 caesarean deliveries, the mean cord arterial PH was similar in the 2 groups (7.25 in the balloon disimpaction group and 7.24 in the control group (p=0.92; Chooi 2023). In the retrospective cohort study of 160 caesarean deliveries, the mean cord arterial pH was statistically significant higher when balloon disimpaction was used (7.24) compared with a hand-push technique (7.19, p=0.003; Safa 2016).
Composite outcome
The cohort study of 1,703 caesareans used a composite neonatal outcome, which included perinatal death, hypoxic ischaemic encephalopathy, seizure, birth trauma, acidosis (cord pH less than 7.10) or neonatal intensive care unit admission for at least 48 hours. The rate for this outcome was 4% both before and after the balloon disimpaction device was introduced to the maternity unit. After the device was introduced to the maternity unit, the rate was 5% (18/375) when the device was used compared with 4% (20/508) when it wasn't used (adjusted OR 1.01, 95% CI 0.51 to 1.99). When comparing 2 different maternity units, the composite neonatal outcome was 5% (27/574) in the unit with availability of the balloon disimpaction device and 7% (33/506) in the unit without availability of the device (adjusted OR 0.73, 95% CI 0.39 to 1.36; Sadler 2024).
Seizures or jitters
In the randomised controlled trial of 50 caesarean deliveries, neonatal seizure was reported in none of the babies in the balloon disimpaction group and 4% of those in the modified Patwardhantechnique group (p=0.03; Dutta 2019). Seizure or jitters was reported in none of the babies in the balloon disimpaction group and 9% (4/47) of babies in the control group, in the cohort study of 101 caesarean deliveries (p=0.045; Chooi 2023).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They listed the following anecdotal adverse events:
Neonatal sepsis
Time to insert
Failure
Three professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
The published evidence includes data from the UK.
One study included some women whose cervix was less than fully dilated (7 cm or above; Chooi 2023). The other studies stated that the caesarean deliveries were done when the cervix was fully dilated or during the second stage of labour.
Of the 2 randomised controlled trials included in the systematic review by Cornthwaite et al. (2024), 1 was assessed as low risk of bias (Lassey 2020) and 1 was at high risk of bias (Dutta 2019). All 5 non-randomised studies included in the review were at serious or critical risk of bias. The certainty of evidence was low or very low, using GRADE criteria. One of the studies was identified as being at risk of retraction and has since been retracted. Another study was published in a journal that was described in the review as 'potentially predatory' (Dutta 2019).
The authors of the systematic review noted that there was a lack of standardisation in the measuring and reporting of outcomes associated with caesarean birth.
One small randomised controlled trial, included in the systematic review, compared an inflated device with an uninflated device. The primary outcome for this trial was the time between hysterotomy and delivery, and it was underpowered to detect significant differences in other outcomes (Lassey 2020).
In the cohort study by Sadler et al. (2023), there were statistically significant differences in demographic and clinical characteristics between comparison groups.
The primary outcome differed between studies.
The fetal head station was not reported in all studies and this is likely to be associated with the degree of difficulty encountered in the delivery.
None of the studies reported the time between the decision to do an emergency caesarean and delivery, or the time taken to insert the balloon disimpaction device.
Most of the studies were underpowered to detect clinically relevant differences in rarer outcomes.
Most of the non-randomised comparative studies were retrospective, so there is a risk of bias in patient selection and definitions of maternal and neonatal outcomes.
Ease of delivery is a subjective outcome and prone to bias.
In the studies by Lassey et al. (2020) and Dutta et al. (2019), balloon disimpaction devices were donated by Safe Obstetric Systems, UK. None of the other studies declared any potential conflicts of interest.
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