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Cervical Ripening Balloon For Induction of Labour in High Risk Pregnancies
Cervical Ripening Balloon For Induction of Labour in High Risk Pregnancies
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Hian Yan Voon, MRCOG, Angeline TY Wong, MB BCh BAO, Moi Ling Ting, MD, Haris Njoo Suharjono, FRCOG
ABSTRACT
Background: The Cervical Ripening Balloon (CRB) is a novel
this problem, grandmultiparous women still contribute a
KEY WORDS:
due to a lower risk of hyperstimulation.
Cervical ripening balloon, double balloon catheter, mechanical, This descriptive study will add to our knowledge of the
induction of labour, previous scar, grandmultiparity efficacy and safety of the CRB in high risk women.
Inclusion criteria were singleton, pregnancies beyond 36 Amniotomy was performed once patient was transferred to
completed weeks with unfavourable modified Bishop score labour ward and oxytocin started 0-4 hours later if
(<7) and vertex presentation. The modified Bishop score has contractions were inadequate, defined as less than 3 in 10
a minimum score of zero and maximum score of 13 (see contractions of moderate strength (40-60 seconds).
Appendix I). For simplicity, the term “Bishop score” is used in
this paper. All patients had either one previous lower Failure of induction was diagnosed if patients did not enter
segment caesarean section and/or grandmultiparity. Women active phase of labour despite at least 6-8 hours of adequate
who were both grandmultiparous and had a previous contractions defined above. Poor progress was diagnosed if
caesarean section would be analysed under the “previous cervical dilatation was <1cm/hour despite 6-8 hours of
caesarean section” subgroup. In this paper, grandmultipara moderate contractions (lasting 40-60 seconds) of at least 3 in
refers to women who have a parity of four and above. Tested 10 minutes, especially after of the use of oxytocin.
scar refers to women who have had one or more successful Hyperstimulation was defined as contractions > 5 in 10
vaginal birth after caesarean (VBAC) minutes or lasting more than 120seconds.
Multiple pregnancies, patients with favourable Bishop scores, Statistical analysis was performed using SPSS version 19 and
more than one previous scar, previous LLETZ (Large Loop significance testing involved the use of Chi Square and Paired
Excision of Transformation Zone) and maternal fever of any T-test. p<0.05 was deemed significant. Sub analysis on the
source were excluded. Patients with any contraindication for success rate of vaginal delivery was performed in patients
vaginal delivery were excluded. Women with favourable with a tested scar and grandmultiparity.
Bishop score were offered amniotomy and oxytocin for IOL
instead. Ethical approval was obtained from Medical Research and
Ethics Committee (MREC) NMRR ID 15-108-24113
Gestational age was determined by patient’s last menstrual
RESULTS
period or by using ultrasound if there were discrepancies
between her dates and ultrasound examination. A
discrepancy of 5 days or less, 7 days or less, 10 days or less A total of 77 patients were identified from patient registry
were permitted at gestations less than 10 weeks, 10-14 weeks between January 2014 and March 2015. Three patients were
and more than 14 weeks respectively. excluded as they did not fulfil the criteria for high risk
inductions. Of the remaining 74 women, four were both
Patients were counselled on the methods of IOL available grandmultiparous and had a previous caesarean section.
including the use of vaginal prostaglandins on admission. All
decisions for induction in our unit are decided by a specialist The patient demographics are as illustrated in Table I, with a
or a consultant. Patients who have agreed for IOL are first mean gestation of 38.9 (Standard Deviation (SD) 1.3) weeks
seen by a registrar in the patient admission centre and (range 36-41.4). The overall success rate of vaginal delivery
indication, risks and methods for IOL were discussed. If after IOL was 50%, although it slightly lower at 44.8% in
decision for IOL was only made as an inpatient, the setting of women with previous caesarean section. However, the success
this discussion would be in the labour suite or antenatal rate increases to 66.7%, when sub analysis was performed in
ward. Patients are subsequently allowed to deliberate on their women with previous tested scars. This was comparable to
decision and re-counseled by an obstetrician. Contents of the success rate in unscarred, grandmultiparous women
discussion and their final decision were documented in the (68.7%). There were no cases of hyperstimulation but one
case notes. Prior to insertion of the CookTM CRB, foetal heart case of intrapartum fever and scar dehiscence each (1.4%).
tracing was recorded via cardiotocography and vaginal
examination was performed to confirm the Bishop score. A There was a significant change in Bishop score prior to
sterile speculum was then introduced to visualise the insertion and after removal of the CookTM CRB. Mean Bishop
cervix,CookTM CRB guided into the os with the use of a pair of score improved from 3.8 (SD 1.8) to 7.0 (SD 1.9). A paired T-
forceps until the clinician was satisfied that the whole uterine test was performed, which found this positive change in
balloon is above the internal os. 40-80 ml of normal saline Bishop score of 3.2 (95% CI 2.8-3.6) to be statistically
was used to inflate the uterine balloon, followed by an equal significant (p<0.01). Of note, the increase in favourability of
amount in the vaginal balloon. Once satisfied with the Bishop score occurred across both subgroups and was not
placement, the speculum was removed and the distal end of limited to grandmultiparous women.
the CookTM CRB plastered to patient’s thigh. The patients were
allowed to ambulate and resume normal activity in the ward. Although the CookTM CRB was planned for insertion between
12-24 hours, more than a third had premature expulsion of
Patient’s were asked to inform the clinician if they had the CRB. Interestingly, women with premature expulsion of
significant discomfort, developed fever, leaking liqour or if CookTM CRB were no more likely to deliver vaginally than
the catheter dislodged. If the CookTM CRB dislodged, the via caesarean (58.6% vs 41.3%; p>0.05).
Bishop score reassessed and aimed for amniotomy once bed
was available in the labour ward. On the other hand, if the Failure to progress/IOL was the main indication for
CookTM CRB remained in-situ, it was removed 12-24 hours caesarean section (54.1%) although two patients had a
later and aimed for amniotomy. caesarean section for abnormal lie or presentation after Cook
™ CRB insertion.
Mode of delivery
BMI (kg/m2) (SD, range) 28.5 (6.1, 19.4-48.7) 28.2 (6.2, 19.4-48.7) 29.8 (5.2, 19.7-37.4)
Complications
Caesarean 37 (50%) 32 (55.2%) 5 (31.2%)
Bishop score
Scar dehiscence 1 (1.4%) 1 0
At insertion (SD, range) 3.8 (1.8, 0.0-8.0) 4.0 (1.8, 0.0-8.0) 3.1 (1.7, 0.0-6.0)
At removal (SD, range) 7.0 (1.9, 2.0-12.0) 7.0 (1.8, 2.0-12.0) 6.7 (1.8, 3.0-11.0)
Mean change in Bishop score (95% CI) 3.2 (2.8-3.6)* 3.1 (2.7-3.6)* 3.5 (2.5-4.5)*
Duration of CRB use (hours) (SD, range) 12.2 (5.4, 3.0-26.0)
Premature expulsion of CRB 29 (39.2%)
Interval insertion-delivery (hours) (SD, range) 27.8 (12.6, 6.5-81.0)
Birthweight (kg) (SD, range) 2.95 (0.41, 1.89-3.90)
SD - Standard Deviation, BMI - Body Mass Index, CI - Confidence Interval, CRB - Cervical Ripening Balloon.
* p-value < 0.01
CONTRIBUTION TO AUTHORSHIP
was confirmed on admission sonographically and clinically
at the point of insertion of the CRB. One patient had a
compound presentation (vertex-hand) in early active phase. VHY conceived and designed the study, analysed the data
The second patient had her CRB expulsed at an os of 3cm but and drafted the manuscript.
the presenting part was vertex at that point. While for the
availability of a room in the labour suite, she developed AWTY was involved in literature review, drafting of the initial
contractions and a repeat vaginal examination found a manuscript and acquisition of the data.
breech presentation. In both patients, the presenting part
remained vertex after removal or expulsion of the balloon. TML acquired, analysed and interpreted the data.
There were no cases of cord prolapse.
HS edited, critically revised the manuscript and provided
There are several limitations to the study, mainly because of approval for the final manuscript.
its observational design, which does not permit the direct
ACKNOWLEGEMENT
comparison with other methods such as prostaglandin or
Foley’s catheter. Other factors which may affect the success
rate of IOL in women with previous scars were not readily The authors wish to acknowledge the contribution of Dr Tan
available, ex. indication of previous caesarean section. In Yiap Loong for his comments, assistance and for sharing his
addition, there was a variable interval between removal of experience during the revision of the manuscript.
CRB and subsequent amniotomy, occasionally protracted due
CONFLICT OF INTEREST
to the demands of a busy unit.
Although the CRB has been shown to be equally efficacious None of researchers have received any sponsorship from or
for induction of labour compared to the use of vaginal have financial interest in the manufacturer of the CookTM
prostaglandins, its cost remains a limiting factor. Currently, a Cervical Ripening Balloon (CookTM Medical, Bloomington,
single tablet of ProstinTM costs about a third of a CookTM CRB. Indiana) or its local agents.
The Foley’s catheter is another increasingly popular and cost
REFERENCES
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CONCLUSION
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