|Year : 2022 | Volume
| Issue : 2 | Page : 93-96
Comparison of Foley's catheter and misoprostol versus misoprostol alone on labour induction
Maria Rafiq1, Seema-Gul Salman2
1 DHQ Hospital, Upper Dir, KPK, Pakistan
2 District Specialist, Category-D Hospital, Peshawar, Pakistan
|Date of Submission||20-Jan-2022|
|Date of Decision||23-Mar-2022|
|Date of Acceptance||24-Mar-2022|
|Date of Web Publication||04-Jul-2022|
House No. 5, Street H, Danish Abad, Peshawar, Kpk
Source of Support: None, Conflict of Interest: None
Background: Labour is traditionally induced with sub lingual (SL) misoprostol but researchers have proposed greater effectives and benefits if Foley's catheter is also used. Aims and Objectives: The aim was to study the effect of cervical Foley's catheter and misoprostol on labour induction in comparison to SL misoprostol alone. Materials and Methods: This randomised controlled trial was conducted from January 2020 to January 2021 on a study population of 96 female patients. They were distributed by lottery method into Groups 0; having been given SL misoprostol alone and Group 1; given the same in addition to cervical Foley's catheter. After randomisation, each group of 48 patients was noted for the method of delivery and time from induction to delivery in hours. Results: Groups 0 and 1 had 48 patients each with a total of 96 patients. Overall means for age in years and age of gestation in weeks were 25.80 ± 5.73 and 39.51 ± 1.13, respectively. Overall parity was 1.88 ± 0.83. Normal vaginal delivery (NVD) was seen in 25 (26%) patients in Group 0 and 34 (35.4%) in Group 1, P = 0.01. Meantime from induction to delivery for Group 0 was 17.89 ± 1.05 h and for Group 1 13.93 ± 1.47 h respectively, with a difference of 3.96 ± 0.42 h and P = 0.01. Conclusion: The combination of misoprostol and Foley's catheter in the cervix is associated with more vaginal deliveries characterised by shorter times of delivery.
Keywords: Foley's catheter, induction of labour, mechanical method, misoprostol, vaginal delivery
|How to cite this article:|
Rafiq M, Salman SG. Comparison of Foley's catheter and misoprostol versus misoprostol alone on labour induction. Hamdan Med J 2022;15:93-6
| Introduction|| |
Labour induction is defined by the Royal College of Obstetricians as the artificial initiation of uterine contractions for progressive cervical dilation, effacement and the birth of the baby. This is done when delivering the baby is more beneficial than the continuation of the pregnancy. Its rate continues to be approximately 1 out of 4 pregnancies. In a large European study, it was found to be 21%. Various reasons for induction include maternal; post-date pregnancy, cardiovascular, renal and haematological causes, pregnancy-induced hypertension and fetal causes; restriction of growth inside the uterus among others. It can also be from a combination of both. Cervical ripening can be achieved both by mechanical and pharmacological techniques. Pharmacological techniques utilize Prostaglandin analogues which are commonly Dinoprostone; E2 or misoprostol an E1 prostaglandin. These are associated with side effects. For this reason, various alternative methods for cost-benefit, simplicity and lack of adverse effects have been developed. Foley's catheter has been shown to be an effective mechanical technique for cervical ripening and labour induction. However, comparative local studies in this regard are lacking. This study was conducted on the hypothesis that comparative Foley's catheter in combination with sub-lingual (SL) misoprostol will be more effective for labour induction compared to misoprostol alone with multiple added benefits; most importantly rates of NVD and shorter duration between labour induction and its delivery.
| Subjects and Methods|| |
This randomised controlled trial was conducted from January 2020 to January 2021 after the hospital's ethical and research committee's approval (Form # 2020/01) and in accordance with the ethical principles mentioned in the Helsinki Declaration 2013. Only patients who consented to participate were studied. The WHO calculator for the size of the sample was utilized with the following parameters to calculate the study population; 5% significance level, 80% power and population test-values of 0.8983 for NVD by SL Misoprostol and 0.65 for NVD by per vaginal (PV) Foley's catheter. This resulted in a study population of 96., These were distributed by lottery method into Groups 0; having been given SL Misoprostol alone and Group 1; given the same in addition to cervical placed Foley's catheter. After randomization using random numbers generator, each group had 48 patients. All patients presenting for delivery through the outpatient department and/or emergency willing to take part in this study including post-date pregnancy were included after valid informed consent and counselling. Those with co-morbids including hypertension, diabetes mellitus and pathologies such as oligohydramnios were also included. Patients with malpresentation, cephalon-pelvic disproportion, grand-multiparty, previous caesarean-section and twin pregnancy were excluded. All data were recorded on a preformed sheet noting biodata, age of gestation (weeks), parity, hours of induction (HOI) and normal vaginal delivery (NVD).
Pharma and mechanical techniques of induction were carried out under specific directives. Misoprostol was given as SL tablet of 200 μgm as only this dosage is readily available in the market and further division into smaller doses is difficult because of the small size. Internationally smaller doses of 50 and 25 μgm are available with the latter being in usual practice to avoid the side effects mentioned above. This was given at time 0 i.e., the start of induction and is usually not repeated at first (RA1) and second reassessments (RA2) at 6 and 12 h respectively. Indications for repeat at reassessment include lack of improvement in Bishop score, absence of uterine contractions but good fetal heart rate (FHR) on CTG. Size 22-French latex Foleys catheter was placed at time 0 using a sterile vaginal speculum under visual guidance into the internal Os and filled with 50-ml normal saline and secured to the patient's thigh with nichiban sticking. In Group 1, misoprostol tablet was given at the time of placement of Foley's catheter.
Patients were monitored with CTG at 1 h and again at 1 h after each reassessment (RA1 and RA2) at 6 and 12 h, respectively. Reassessment was done with palpation for uterine contraction, CTG and Bishop score. If at reassessment, there were no palpable uterine contractions within a 10-min duration and Bishop's score was ≤6 with reassuring FHR trace, the induction was continued. Misoprostol was repeated if induction was inadequate at 6 and 12 h, respectively. Foley's catheter was removed if induction was inadequate at RA2 (12 h) or FHR was non-assuring.
Criteria for ending the induction were abnormal FHR on CTG and meconium-stained liquor after membrane rupture; spontaneously or artificially. In such cases, an emergency lower segment caesarean (EM-LSCS) was done. This was also performed, if misoprostol failed after three attempts, i.e., at RA2 (12 h).
Data from the pre-formed proforma was analysed on SPSS 23. Effect modification from variables such as age, age of gestation and parity were controlled by stratification. Quantitative data, age, age of gestation, parity and hours from induction to delivery, were expressed as means and standard deviation. Group comparison was done after stratification. A comparison of the groups in terms of hours from induction to delivery was done with an independent sample t-test. Qualitative data including delivery mode was expressed as frequency and percentage. A comparison of the groups in terms of delivery mode was done with the Chi-square test. P ≤ 0.05 was accepted as statistically significant.
| Results|| |
Total number of patients was 96 with 48 in each group. Overall values were; age 25.80 ± 5.73 years, age of gestation 39.51 ± 1.13 weeks, parity 1.88 ± 0.83 and induction time in hours (HOI) 15.91 ± 2.36 h, respectively. Overall, a total of 37 patients were delivered by caesarean and 59 by NVD in both groups.
The mean age (years) for Groups 0 and 1 was 25.85 ± 6.05 and 25.75 ± 5.45 respectively with P value 0.9. The mean age of gestation (weeks) for Groups 0 and 1 was 39.35 ± 1.06 and 39.66 ± 1.19, respectively, with P value 0.1. Mean parity for Groups 0 and 1 was 1.81 ± 0.84 and 1.94 ± 0.83, respectively, with P value 0.4.
Mean induction time in hours (HOI) for Groups 0 and 1 was 17.89 ± 1.05 and 13.93 ± 1.47 respectively with a P value of 0.01. This was statistically significant with a difference of 3.96 ± 0.42 h between the groups. 23 (24%) of patients in Group 0 were delivered by caesarean compared to 14 (14.6%) in Group 1 and 25 (26%) patients had delivery by NVD in Group 0 compared to 34 (35.4%) patients in Group 1, respectively. This was also statistically significant with a P = 0.01.
Indications for caesarean in Group 1 among the 14 (14.6%) patients included fetal distress, non-progress of labour and and poor Bishop score. However, with close monitoring, there were no serious complications including uterine hyperstimulation, uterine rupture, post-partum hemorrhage (PPH), neonatal compromise or admission to the neonatal intensive care unit (NICU). The complete data are given in [Table 1].
| Discussion|| |
Modern methods for induction of labour include pharmacological techniques using prostaglandin analogues, misoprostol E1 or dinoprostone E2. Misoprostol E1 has been shown to be more effective for cervical ripening and labour induction whereas dinoprostone has greater safety. However, both are associated with side effects and the latter is costly and requires special storage requirements. For this purpose, multiple alternatives including mechanical techniques have been developed. The placement of Foley's catheter into the internal Os has been shown to be effective and has results similar to prostaglandins.,, It has been shown to induce labour within 12–24 h foregoing the need for administration of oxytocin and is not associated with increased rates of caesarean. There are multiple reasons for this. The use of a single terminal balloon Foley's placed into the internal Os exerts physical expansion, releases prostaglandins, facilitates the ongoing dilation of the cervix and cervical secretion of oxytocin and increases collagen synthesis at the Os.
A combination of pharma and mechanical methods for labour induction is associated with associated with even rapid rates of safe and effective induction, shorter times to delivery and better feto-maternal outcomes.,, Few local studies have been carried out in this regard which shows similar results.
Priyadarshini et al. in their study showed that HOI was shorter in the catheter + misoprostol group; 19.65 ± 9.21 versus 24.99 ± 12.76 h with a difference of 5.34 ± 3.55 h which was statistically significant at a P value of 0.002. This was also shown by Al-Ibraheemi et al. in their study with the intervention group, time to delivery at 15 h versus 19 h in the control group which was also statistically significant at a P = 0.001. Similarly, Husain et al. in their study showed that the HOI for the interventional group was significantly shorter at 13 h compared to the control at 19 h with a P = 0.001. These are also supported by multiple meta-analyses where the combination of Foley's catheter and misoprostol resulted in a shorter HOI compared to misoprostol alone.,
In their studies, the above authors have also shown that combination Foley's and misoprostol is also associated with more NVDs and lesser caesareans; 76 NVDs versus 56 and 23 caesareans versus 43 by Priyadarshini et al., 155 caesareans versus 185 by Ten Eikelder et al. and 22% versus 26% caesareans by Ten Eikelder et al. However, Al-Ibraheemi et al. showed that there was no difference between the groups in terms of the indication or rate for caesarean section. Husain et al. showed that fewer women failed to achieve NVD with the combination of 11.8% versus 28.7%. This is also supported by a number of meta-analyses.,
In comparison to previous studies, with close monitoring and strict application of the RCOG guidelines including administration of misoprostol only after palpable contractions and Bishop score, we managed to keep maternal complications low. Therefore, serious complications including uterine hyperstimulation, uterine rupture, PPH, neonatal compromise or admission to the NICU were avoided. In addition, only a few studies have simultaneously compared Foley's catheter and misoprostol versus misoprostol alone. However, the addition of blinding, pharmacological methods such as oxytocin and the use of instrumental modes of delivery which would have added to the strength of this research were not included due to various limitations.
Despite the above shortcomings, the research established that the combination of Foley's catheter and misoprostol is associated with a greater frequency of normal vaginal delivery NVD. For its simplicity, safety, better cost-effect and fewer complications this combination can be recommended as the standard for labour induction.
| Conclusion|| |
The combination of misoprostol and Foley's catheter in the cervix is associated with more vaginal deliveries characterised by shorter times of delivery.
The study was carried out after approval from the hospital's ethical and research committee (Form # 2020/01) and conducted in accordance with the ethical principles mentioned in the Helsinki Declaration 2013.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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