Interventional procedure overview of balloon disimpaction of the baby's head at emergency caesarean
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Summary of key evidence on balloon disimpaction of the baby's head at emergency caesarean
Study 1 Di Girolamo R (2021)
Study type | Systematic review |
|---|---|
Country | Studies were based in UK, Australia and India |
Recruitment period | Search date: February 2021; study periods were from 2011 to 2019 |
Study population and number | n=1,326 (684 with balloon disimpaction of the baby's head); 10 studies Women having full dilation caesarean with or without balloon disimpaction of the baby's head |
Age | Not reported |
Patient selection criteria | Inclusion criteria were studies exploring maternal and perinatal outcomes in women having a balloon fetal head elevation device compared to those not having a balloon fetal head elevation device at full dilation caesarean section. Only studies reporting the outcome of women having full dilation caesarean section for which extraction was attempted using fetal pillow compared to other approaches (maternal pushing or breech extraction) were considered eligible for inclusion. Prospective and retrospective case-control studies, case reports and case series were analysed. Opinions, cases series with fewer than 3 cases and case reports were excluded. |
Technique | A fetal pillow device was compared to other approaches (not described for individual studies) |
Follow up | Not reported |
Conflict of interest/source of funding | None |
Analysis
Study design issues: The review was done according to an a-priori designed protocol, recommended for systematic reviews and meta-analysis (Cochrane). The aim of the review was to evaluate if the use of a fetal pillow device reduces the rate of complication and improves maternal, fetal and neonatal outcome compared to other methods. Of the 10 included studies, 2 were randomised controlled trials and the rest were case-control series (4 prospective and 4 retrospective). Quality assessment was done using the Newcastle-Ottawa Scale for cohort studies. Most of the studies showed an overall good score regarding the selection and comparability of the study groups, and for ascertainment of the outcome of interest. The main weaknesses were small sample size, non-randomised design, heterogeneity in outcome assessment and definition and lack of stratification according to fetal head station. Uterine incision extension was defined as any uterine wall defect, either laterally into the uterine vasculature or vertically into the cervix or contractile uterus, that needed additional surgical steps to repair.
Study population issues: There was no difference in the mean maternal and neonatal characteristics potentially affecting the explored outcomes between the 2 groups, including age, body mass index, neonatal weight, and fetal head station.
Key efficacy findings
Number of patients analysed: 1,326 (684 with balloon disimpaction of the baby's head and 642 without)
Maternal outcomes | Studies (n) | sample sizes (n vs n) | mean difference (95% CI) | p value |
|---|---|---|---|---|
Mean uterine incision to delivery interval (seconds) | 2 | 150 vs 150 | -52.26 (-55.2 to -34.94) | <0.001 |
Mean estimated blood loss (ml) | 5 | 421 vs 398 | -130.82 (-130.1 to -381.0) | <0.001 |
Length of hospital stay (days) | 4 | 314 vs 334 | -0.884 (-1.07 to -0.70) | <0.001 |
Perinatal outcomes | Studies (n) | sample sizes (n vs n) | mean difference (95% CI) | p value |
Mean neonatal umbilical artery pH | 2 | 205 vs 129 | 0.617 (0.43 to 0.88) | <0.001 |
Maternal outcomes | Studies (n) | Pregnancies (n/N vs n/N) | Pooled odd ratios (95% CI) | I2 (%) | p value |
|---|---|---|---|---|---|
Uterine incision extension | 6 | 91/541 vs 144/518 | 0.50 (0.3 to 0.9) | 68.6 | 0.0213 |
Estimated blood loss >1000 ml | 4 | 60/454 vs 84/525 | 0.55 (0.2 to 1.7) | 81.6 | 0.3005 |
Need for blood transfusions | 7 | 17/591 vs 47/642 | 0.39 (0.2 to 0.7) | 40.9 | 0.0365 |
Operative complications | 3 | 19/250 vs 22/198 | 0.44 (0.2 to 0.9) | 5.7 | 0.0323 |
Urinary retention | 2 | 2/130 vs 2/70 | 0.76 (0.1 to 9.7) | 38.4 | 0.8301 |
Hospital readmission | 2 | 9/130 vs 5/78 | 0.98 (0.3 to 2.9) | 0 | 0.9688 |
Perinatal outcomes | Studies (n) | Pregnancies (n/N vs n/N) | Pooled odd ratios (95% CI) | I2 (%) | p value |
Apgar score <3 at 1 min | 2 | 3/170 vs 12/244 | 0.41 (0.03 to 4.4) | 67.4 | 0.4649 |
Apgar score <7 at 5 min | 3 | 120/375 vs 72/350 | 1.01 (0.5 to 1.9) | 0 | 0.9654 |
Neonatal sepsis | 2 | 0/170 vs 11/244 | 0.10 (0.01 to 0.99) | 0 | 0.0497 |
Admission to NICU | 6 | 82/561 vs 103/612 | 0.63 (0.5 to 0.9) | 0 | 0.0077 |
Need for endotracheal intubation | 3 | 1/171 vs 9/223 | 0.26 (0.04 to 1.4) | 0 | 0.1149 |
Neonatal death | 2 | 0/170 vs 5/244 | 0.18 (0.01 to 1.8) | 0 | 0.1475 |
Key safety findings
No safety outcomes directly related to the use of balloon fetal head elevation deviceswere reported.
Study 2 Lassey S (2020)
Study type | Randomised controlled trial |
|---|---|
Country | US (single tertiary centre) |
Recruitment period | 2018 to 2019 |
Study population and number | n=60 (30 balloon fetal head elevation device inflated, 30 balloon fetal head elevation device not inflated) Women who had caesarean delivery during the second stage of labour |
Age | Median: inflated group=33 years, not-inflated group=30.5 years |
Patient selection criteria | Women were at least 18 years old with a full term (37 weeks of gestation or greater) singleton fetus in cephalic presentation. Only nulliparous women were included. Women were excluded if there was a contraindication to a vaginal delivery, prior caesarean delivery, or presence of congenital fetal anomaly. Non–English speaking women were also excluded. |
Technique | The Fetal Pillow cephalic elevation device (Safe Obstetric Systems) was used. At the time of caesarean delivery, the cephalic elevation device was inserted vaginally by the obstetrician after catheterisation of the bladder and after vaginal preparation with betadine. The delivering provider and other members of the obstetric team were blinded to whether the device was inflated or not. The anaesthetist inflated the cephalic elevation device using 180 ml normal saline (inflated group) or did not inflate the balloon (not-inflated group). In both groups, most women had a low transverse caesarean delivery (93%). |
Follow up | To hospital discharge |
Conflict of interest/source of funding | 1 author is a member of the North America Patient Blood Management Scientific Advisory Committee for Instrumentation Laboratory and is an investigator on grants to Brigham and Women's Hospital from Pacira Biosciences and Gauss Surgical. |
Analysis
Follow-up issues: There were no withdrawals or patients lost to follow up after randomisation.
Study design issues: Double-blind randomised controlled trial comparing delivery with inflated or non-inflated balloon disimpaction device. Women who were to have a caesarean delivery in the second stage of labour were randomly allocated to either the cephalic elevation device inflated group or the not-inflated group. An independent consultant created a computer-generated randomisation scheme that used balanced treatment allocation in blocks of 10, and the resulting sequential group allocations were kept in sealed, opaque envelopes until time of randomisation. The primary outcome measure was time (in seconds) from hysterotomy to delivery of the neonate, measured by the anaesthetist. The average time from uterine incision to delivery in seconds in a pilot study of 20 patients was 41 seconds. Decreasing this by half was considered to be clinically meaningful and a sample size of 60 was calculated, assuming 80% power. Analysis was by intention to treat.
Study population issues: Women in the inflated group were older (33.0 compared with 30.5 years) but otherwise had similar baseline characteristics as the not-inflated group. The indication for caesarean delivery was failure to progress in 90% (27/30) of women in the inflated group and 77% (23/30) of women in the not-inflated group. Non-reassuring fetal heart rate tracing was the indication in 17% (5/30) of women in the inflated group compared with 30% (9/30) of women in the not-inflated group. The median birth weight was 3.50 kg in the inflated group and 3.39 kg in the non-inflated group. The median fetal station was 2 in both groups.
Other issues: This study is also included in the systematic review by Di Girolamo et al. (2021).
Key efficacy and safety findings
Number of patients analysed: 60 (30 inflated balloon fetal head elevation device, 30 not-inflated balloon fetal head elevation device)
The device was unable to be successfully inflated for 1 person in the inflated group.
Outcome | Inflated group, median (quartile 1 to quartile 3) or n (%) | Not-inflated group, median (quartile 1 to quartile 3) or n (%) | Mean difference between groups* | p value |
|---|---|---|---|---|
Uterine incision-to-delivery time (seconds) | 31 (24 to 37) | 54 (41 to 72) | -38.2 (-56.1 to -20.3) | <0.01 |
Total operating time (minutes) | 56 (50 to 62) | 59 (52 to 70) | -8.7 (-18.5 to 1.2) | 0.14 |
Uterine incision extension | 6 (20) | 13 (43) | -0.23 (-0.46 to -0.01) | 0.05 |
type 1 (easy to suture) | 5 (17) | 2 (7) | - | 0.02 |
type 2 (increased operative time and blood loss) | 1 (3) | 7 (23) | - | - |
type 3 (into the cervix, vagina or bladder) | 0 (0) | 4 (13) | - | - |
* risk difference with 95% CI for categorical variables and mean with 95% CI for continuous variables
Outcome | Inflated group, median (quartile 1 to quartile 3) or n (%) | Not-inflated group, median (quartile 1 to quartile 3) or n (%) | Mean difference between groups | p value |
|---|---|---|---|---|
Blood loss (ml) | 800 (700 to 900) | 900 (750 to 1,050) | -191.7 (-370.3 to -13.0) | 0.09 |
Change in haematocrit | -8.0 (5.7 to 9.5) | -8.6 (5.4 to 10.9) | -0.6 (-2.3 to 1.0) | 0.53 |
Blood transfusion | 0 (0) | 3 (10) | -0.1 (-0.21 to 0.01) | 0.24 |
Maternal length of stay (days) | 4 (4 to 4) | 4 (4 to 4) | -0.1 (-0.2 to 0.1) | 0.43 |
Maternal fever | 6 (20) | 5 (17) | 0.10 (-0.16 to 2.3) | 1.0 |
Prolonged catheterisation (more than 4 days) | 0 (0) | 0 (0) | - | 1.0 |
Intensive care unit admission | 0 (0) | 0 (0) | - | 1.0 |
Disseminated intravascular coagulation | 0 (0) | 1 (3) | -0.03 (-0.1 to 0.03) | 1.0 |
Readmission | 0 (0) | 1 (3) | -0.03 (-0.1 to 0.03) | 1.0 |
Outcome | Inflated group, median (quartile 1 to quartile 3) or n (%) | Not-inflated group, median (quartile 1 to quartile 3) or n (%) | Mean difference between groups | p value |
|---|---|---|---|---|
1-minute Apgar score | 8 (8 to 8) | 8 (8 to 8) | 0.0 (-1.1 to 1.0) | 0.92 |
5-minute Apgar score | 9 (9 to 9) | 9 (9 to 9) | -0.1 (-0.5 to 0.3) | 0.84 |
Need for intubation | 1 (3) | 2 (7) | 0.1 (-0.14 to 0.1) | 1.0 |
Neonatal intensive care unit length of stay (days) | 0 (0 to 0) | 0 (0 to 0) | -1.1 (-2.9 to 0.8) | 0.91 |
Other fetal trauma | 0 (0) | 2 (7) | -0.1 (-0.16 to 0.02) | 0.49 |
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).
Study 3 Seal S (2016)
Study type | Randomised controlled trial |
|---|---|
Country | India (2 teaching hospitals) |
Recruitment period | 2013 to 2014 |
Study population and number | n=240 (120 with balloon disimpaction of the baby's head, 120 without balloon disimpaction of the baby's head) Women who had caesarean delivery at full dilatation |
Age | Mean 22 years (range 18 to 33) |
Patient selection criteria | Patients who were able to give informed consent when the decision was made for a caesarean delivery at full dilatation were eligible for the study. Patients at fewer than 36 weeks of pregnancy and those with active genital infections were excluded. |
Technique | The Fetal Pillow (Safe Obstetric Systems, UK) device was used. In the control group, the surgeon was allowed to use an appropriate conventional method of delivery including pushing from below and reverse breech extraction. All deliveries were lower-segment caesarean deliveries. |
Follow up | To hospital discharge. |
Conflict of interest/source of funding | 2 medical colleges in India jointly funded the trial and Safe Obstetric Systems (UK) provided the devices. The authors had no conflicts of interest. |
Analysis
Study design issues: Randomised controlled trial comparing delivery with or without balloon disimpaction device. The groups were allocated in blocks of 10 using computer generated random numbers, which were placed in sealed opaque envelopes. Each component of a block was opened in sequence when the consent form was signed. Group assignment was not masked. The frequency of major uterine wound extensions (grades 2 to 3) was the primary outcome measure. An incidence of major uterine wound extensions of 15% without a balloon device and 4% with it was used to calculate a sample size of 108 patients in each group, with a type 1 error of 0.05 and type 2 error of 0.20.
Study population issues: There were no statistically significant differences in baseline characteristics between the 2 groups. The fetal head station was 0 in 1.7% (4/240) of patients, 1 in 40.0% (96/240) and 2 in 58.3% (140/240) of patients. The overall mean birthweight was 2.9 kg.
Other issues: This study is also included in the systematic review by Di Girolamo et al. (2021).
Key efficacy findings
Number of patients analysed: 240 (120 with balloon fetal head elevation device, 120 without balloon fetal head elevation device)
Outcome | With fetal head elevation device, n=120 | Without fetal head elevation device, n=120 | Mean difference, or relative risk (95% CI) or p value |
|---|---|---|---|
Mean total time for delivery (SD), minutes | 32.7 (4.3) | 53.9 (10.3) | -21.1 (-19.1 to -23.1) |
Mean incision-to-delivery interval (SD), seconds | 176.5 (14.0) | 297.2 (27.1) | -102.7 (-97.2 to -108.2) |
Difficulty with delivery of fetal head | <0.001 | ||
Very difficult, n (%) | 2 (1.7) | 26 (21.7) | - |
Difficult, n (%) | 5 (4.2) | 21 (17.5) | - |
Moderately easy, n (%) | 11 (9.2) | 3 (2.5) | - |
Easy, n (%) | 57 (47.5) | 31 (25.8) | - |
Very easy, n (%) | 45 (37.5) | 39 (32.5) | - |
Mean preoperative haemoglobin (SD), g/l | 103 (6) | 103 (5) | 0.01 (-0.13 to 0.14) |
Mean postoperative haemoglobin (SD), g/l | 96 (5) | 90 (8) | 0.60 (0.43 to 0.76) |
Uterine extensions, n (%) | 12 (10.0) | 43 (35.8) | 0.37 (0.22 to 0.63) |
Grade of uterine incision extension | 0.004 | ||
grade 1, n (%) | 6 (50.0) | 4 (9.3) | - |
grade 2, n (%) | 3 (25.0) | 12 (27.9) | - |
grade 3, n (%) | 3 (25.0) | 27 (62.8) | - |
Major uterine incision extension (grades 2 to 3), n (%) | 6 (5.0) | 39 (32.5) | 0.23 (0.11 to 0.48) |
Blood loss >1000 ml, n (%) | 5 (4.2) | 26 (21.7) | 0.29 (0.13 to 0.66) |
Blood transfusion, n (%) | 4 (3.3) | 22 (18.3) | 0.28 (0.11 to 0.70) |
Mean duration of hospital stay (SD), days | 3.9 (0.8) | 5.0 (1.2) | -1.1 (-1.34 to -0.82) |
Re-laparotomy, n (%) | 0 (0) | 4 (3.3) | 0.12 |
Outcome | With fetal head elevation device, n=120 | Without fetal head elevation device, n=120 | Relative risk (95% CI) or p value |
|---|---|---|---|
5-minute Apgar score ≤3, n (%) | 1 (0.8) | 8 (6.7) | 0.22 (0.03 to 1.37) |
Admission to neonatal intensive care unit, n (%) | 13 (10.8) | 21 (17.5) | 0.74 (0.47 to 1.15) |
Neonatal intensive care unit stay >24 h, n (%) | 3 (23.1) | 12 (57.1) | 0.38 (0.12 to 1.13) |
Neonatal sepsis, n (%) | 0 (0) | 4 (3.3) | 0.12 |
Neonatal death, n (%) | 0 (0) | 3 (2.5) | 0.25 |
Key safety findings
There were no fetal or maternal injuries attributable to use of the fetal pillow device.
Study 4 Sengupta M (2019)
Study type | Randomised controlled trial |
|---|---|
Country | India |
Recruitment period | 2016 to 2017 |
Study population and number | n=50 (25 balloon disimpaction, 25 reverse breech extraction) Women who had caesarean delivery at full dilatation |
Age | 64% (32/50) of women were aged 20 to 25 years, 24% (12/50) were aged 25 to 30 years, 8% (4/50) were 30 to 35 years and 4% (2/50) were over 35. |
Patient selection criteria | Inclusion criteria: pregnancy of gestational age 36 weeks or more, pregnancies that were confirmed by vaginal examination to be having obstructed labour, pregnant women having singleton pregnancy and certain of their last menstrual period. Exclusion criteria: patients whose first-degree relatives had refused to give consent, patients with sexually transmitted infections, hepatitis B surface antigen positive, immunocompromised states, vaginal lesions, multifetal gestation, non-cephalic presentation, fetal malformation. |
Technique | Fetal pillow device was used in the balloon disimpaction group. |
Follow up | To hospital discharge |
Conflict of interest/source of funding | None |
Analysis
Study design issues: The report does not describe the study as a randomised controlled trial but a process of randomising patients to each treatment allocation is described. Computer generated randomisation was used. Treatment allocation was written on index cards and concealed in identical, sealed, opaque, sequentially numbered envelopes stored in the operating room. The objectives of the study were: to compare the extension of uterine incision in both techniques, to compare the operating time and uterine incision to delivery time of the 2 techniques, to assess the degree of blood loss and need for blood transfusion, length of hospital stay, maternal pyrexia, high dependency unit admission and to compare fetal complications such as low Apgar score, neonatal intensive care unit admission, neonatal seizure, neonatal injury or death.
Study population issues: Baseline characteristics of the 2 groups were not presented separately. Most of the neonates (74%) weighed 2.5 to 3.5 kg and 10% (5/50) weighed more than 4 kg at birth. The fetal head station was 0 in 24% (12/50) of patients and 1 or 2 in the remainder (there is a discrepancy in the proportions of each reported in the text and table).
Other issues: this study was not included in the systematic review by Di Girolamo et al. (2021).
Key efficacy and safety findings
Number of patients analysed: 50 (25 balloon disimpaction, 25 reverse breech extraction)
Outcome | Balloon disimpaction, n=25 | Reverse breech extraction, n=25 | p value |
|---|---|---|---|
Extension of uterine incision | 2 (8%) | 6 (24%) | 0.001 |
Operating theatre time (minutes) | 0.02 | ||
30 to 40 | 20 (80%) | 16 (64%) | |
40 to 50 | 3 (12%) | 17 (28%) | |
50 to 60 | 2 (8%) | 1 (4%) | |
more than 60 | 0 (0%) | 1 (4%) | |
Uterine incision to delivery time (minutes) | 0.04 | ||
0 to 2 | 13 (52%) | 2 (8%) | |
2 to 4 | 12 (48%) | 11 (44%) | |
4 to 6 | 0 (0%) | 12 (48%) | |
Number of mops soaked in blood | 0.02 | ||
1 | 3 (12%) | 0 (0%) | |
2 | 18 (72%) | 20 (80%) | |
more than 2 | 4 (16%) | 5 (20%) | |
Blood transfusion needed | 0 (0%) | 4 (16%) | 0.002 |
Special newborn care unit admission | 3 (12%) | 15 (60%) | 0.04 |
Neonatal seizures | 0 (0%) | 1 (4%) | 0.03 |
In the reverse breech extraction group, 1 of the 15 babies admitted to the special newborn care unit had bruises over the back and abdomen and died on day 11.
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