|Year : 2019 | Volume
| Issue : 4 | Page : 1393-1396
Comparison between intracervical Foley catheter plus misoprostol and misoprostol alone for labor induction
Osama A El-Kelani1, Alaa El-Deen F El-Halaby1, El-Sayed A El-Shamy1, Taher N Abd El-Fattah2
1 Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Obstetrics and Gynecology, Benha Health Insurance Hospital, Benha, Egypt
|Date of Submission||01-Nov-2018|
|Date of Decision||18-Dec-2018|
|Date of Acceptance||01-Jan-2019|
|Date of Web Publication||31-Dec-2019|
Taher N Abd El-Fattah
Toukh, Qalyubia Governorate
Source of Support: None, Conflict of Interest: None
Background and objective
Potential advantages of mechanical methods, compared with pharmacological methods, may include simplicity of preservation, lower cost, and reduction of the adverse effects. The objective of this study was to compare the efficacy of combined intracervical Foley catheter and vaginal misoprostol with vaginal misoprostol alone for labor induction.
Participants and methods
This study was a prospective randomization clinical trial carried out from July 2016 to May 2018 in Benha Health Insurance Hospital. Two hundred pregnant women underwent induction of labor with singleton pregnancies at full-term gestation with (Bishop Score ≤6) by Foley catheter plus vaginal misoprostol (group A, n = 90) or vaginal misoprostol alone (group B, n = 110). Women with fetal malpresentation, multiple pregnancies, spontaneous labor, contraindication to prostaglandins, intrauterine growth restriction, anomalous fetus, and in active phase of labor, or previous cesarean delivery were excluded. The outcome measures were induction-to-delivery time, mode of delivery, oxytocin use, tachysystole with fetal decelerations, complications, neonatal Apgar scores, and neonatal ICU admission. Data were expressed as mean ± SD. Student's t-test was used to compare the mean difference between the two groups, and P value is used to determine the significance of the result.
The mean induction-to-delivery time was shorter in group A when compared with group B (14.5 ± 4.1 h compared with 18.9 ± 5.2 h, difference 4.4 ± 1.1 h). There were no differences in labor complications or adverse neonatal and maternal outcomes.
A combined method resulted in a shorter induction-to-delivery time without increasing labor complications.
Keywords: Foley catheter, induction of labor, misoprostol
|How to cite this article:|
El-Kelani OA, El-Halaby ADF, El-Shamy ESA, Abd El-Fattah TN. Comparison between intracervical Foley catheter plus misoprostol and misoprostol alone for labor induction. Menoufia Med J 2019;32:1393-6
|How to cite this URL:|
El-Kelani OA, El-Halaby ADF, El-Shamy ESA, Abd El-Fattah TN. Comparison between intracervical Foley catheter plus misoprostol and misoprostol alone for labor induction. Menoufia Med J [serial online] 2019 [cited 2020 Jan 17];32:1393-6. Available from: http://www.mmj.eg.net/text.asp?2019/32/4/1393/274261
| Introduction|| |
Induction of labor is the artificial initiation of labor before its spontaneous onset to deliver the fetoplacental unit. The frequency of induction varies by location and institution .
The pregnant women undergo induction of labor for various reasons as post-term pregnancy, intrauterine growth restriction, preeclampsia, diabetes mellitus, oligohydramnios, and abnormal results of antepartum surveillance .
There are many proposed methods for induction of labor including mechanical (supracervical Foley bulb and laminaria tents) and chemical methods (synthetic prostaglandins and oxytocin). These methods can be used alone but are most often used in combination with each other .
Misoprostol, a PGE1 methyl analog, has become the prostaglandin of choice in more recent studies for induction of labor. This is because it is cheaper, easy to store because of thermostability, and can be used by many ways with efficacy. As for the main undesirable effect as uterine hyperstimulation, the use of low doses (25 mcg) every 4–6 h has been determined to be safe. In addition, this is the only prostaglandin really available in the domestic market .
The aim of this study was to compare the efficacy of a combination of the Foley bulb and vaginal misoprostol with vaginal misoprostol alone for labor induction.
| Participants and Methods|| |
This study was carried out in Obstetrics and Gynecology Department, Benha Health Insurance Hospital, on 200 women undergoing induction of labor with singleton pregnancies at full-term gestation with an unfavorable cervix (Bishop Score ≤6). Outcomes measures are: primary outcomes, which are induction-to-delivery time, mode of delivery, and emergency cesarean section, and secondary outcomes, which are fetal distress, atonic uterus, hyperstimulation, tachysystole, neonatal Apgar scores, neonatal ICU admission, chorioamnionitis, endometriosis, and post-partum hemorrhage.
Sample size calculation
Sample size was calculated using PS software, v. 3. (Informer Technologist In. 12 Chestergate, Macclesfield, Cheshire, SK11 6BA, United Kingdom), based on a previous study by Carbone and colleagues. The study reported mean induction-to-delivery time of 15.3 h in Foley plus misoprostol arm versus 18.3 h in misoprostol only arm. Total sample size of 200 (90 women in Foley plus misoprostol arm and 110 women in misoprostol only arm) will be sufficient to provide 80% power and 5% significance level to detect such difference.
Patients were randomly divided into two groups:
- Group A: women in this group received vaginal misoprostol per standard protocol at 25 μg every 4 h. In addition, 16-Fr Foley's catheter was inserted through the cervix into the lower uterine segment. The bulb was inflated with 30 ml of normal saline; the Foley's catheter was left in place for a maximum period of 12 h or till its spontaneous expulsion or till a ripe cervix was reached (Bishop Score >6)
- Group B: women in this group received 25 μg of misoprostol per vagina every 4 h. Once the cervix became favorable (Bishop Score >6) or the patient was in active labor, misoprostol administration was discontinued.
Informed written consents were obtained from the patients participating in this study after informing them about the steps of study, the complications, and the capability to withdraw at any time.
This study was approved by the research ethics committee at Faculty of Medicine, Menoufia University.
Data management and statistical analysis were done using SPSS, version 23 (SPSS Inc., Chicago, Illinois, USA). Numerical data was summarized as means and SDs. Categorical data were summarized as numbers and percentages. Before analysis, numerical data were assessed for normality using normality tests and direct visualization methods. Comparisons between both groups were done using independent t-test for numerical data. Categorical data were compared using χ2-test. All P values were two sided. P values less than 0.05 were considered significant. The results will be tabulated, graphically represented, and statistically analyzed using standard statistical methods.
| Results|| |
Regarding the mean ± SD time of induction-to-delivery interval in the two groups, in group A, it was 14.5 ± 4.1 h, which was significantly decreased when compared with group B (18.9 ± 5.2 h) [Table 1].
|Table 1: Induction-to-delivery interval and mode of delivery in the two studied groups|
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Regarding the numbers and percentages of normal and cesarean delivery and indications of cesarean in both groups, in group A it was 90 and 10%, respectively, which was not significantly different when compared with group B, which was 80 and 20%, respectively. Moreover, the indications for cesarean section were failure to progress in 6.67% for group A and 3.65% for group B, failed induction in 0.0% for group A and 10.9% for group B, and fetal distress in 3.33% for group A and 5.45% for group B [Table 1].
Regarding the mean ± SD Apgar score at 1 and 5 min in the two groups, in group A, it was 7.4 ± 1.5 and 6.4 ± 2.1 at 1 and 5 min, respectively, which was not significantly different when compared with group B, which was 7.5 ± 1.6 and 8.2 ± 0.7, respectively [Table 2].
|Table 2: Neonatal Apgar score at 1 and 5 min and admission to neonatal ICU in the two studied groups|
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Regarding the numbers and percentages of neonates needing neonatal ICU in both groups, it was 1 and 3.6% in groups 1 and 2, respectively, showing that there is no significant difference between the two groups [Table 2].
There was no statistical difference between the two groups in the incidence of fetal distress, tachysystole, or meconium passage [Table 3].
The risks of chorioamnionitis, endometritis, post-partum hemorrhage, and hyperstimulation were also not significantly different in the two groups.
| Discussion|| |
In this study, regarding the mean induction-to-delivery interval, there was a highly significant difference (P < 0.05).
This is in agreement with Hill et al. . This study reported that the duration between induction and delivery in Foley catheter plus oral misoprostol group was significantly shorter than that of vaginal misoprostol group.
In addition, our results were in agreement with the study done by Chen et al.  who reported that the combination group had a decreased time to delivery [mean difference: −2.36 h, 95% confidence interval (CI): −4.07 to − 0.66, with significant P value].
Moreover, Carbone et al.  showed similar results in the randomized trial of 123 pregnant women undergoing induction of labor with an unfavorable cervix (Bishop Score ≤6), where the mean induction-to-delivery time was 3.1 h shorter for the combination of the Foley bulb and vaginal misoprostol than for vaginal misoprostol alone (95% CI: –5.9 to –0.3).
In contradiction to our study, Fekrat et al.  evaluated three methods of cervical ripening with vaginal misoprostol and Foley catheter and the combination of these two methods, and they reported that vaginal misoprostol was more effective than other two methods in the time-to-delivery interval.
In this study, regarding the route of delivery, there is no significant difference between the two groups, with nonsignificant P value.
Similar results were reported by Chung et al.  who compared three groups: one on misoprostol alone, second on Foley catheter alone, and the third is in combination of them. They showed that there was no difference in the vaginal delivery rates (misoprostol, 63.3%; Foley alone, 57.4%; and combination, 58.1%; with nonsignificant P value).
Similar results were reported by Hill et al.  who stated that there was no statistical difference between the groups regarding route of delivery, and there was no significant difference between the two groups in the view of cesarean inductions.
Different results were obtained by Culver et al.  who reported that among patients induced for preeclampsia, the cesarean delivery rate was significantly lower for those induced with Foley's catheter with concurrent use of oxytocin [five (15%) of 33 versus 16 (48%) of 33 in misoprostol group; with significant P value], whereas Roudsari et al.  showed that the rate of vaginal delivery was significantly higher in misoprostol group [44 (89.8%) compared with 37 (62.7%) in Foley's catheter group]. In addition, there was a statistically significant difference in the rate of cesarean section (10.2% in the misoprostol group compared to 37.3% in the Foley's catheter group).
Regarding the occurrence of complications to any of the modalities in the study, there was no statistical significant difference between the two groups.
Carbone et al.  showed similar results in the randomized trial of 123 pregnant women undergoing induction of labor. There were no differences in labor complications or adverse neonatal and maternal outcomes.
Opposite results were obtained by Chen et al.  who showed that the risk of chorioamnionitis was significantly increased in the combination group (risk ratio = 2.07, 95% CI: 1.04–4.13; P = 0.04), and that of tachysystole with fetal heart rate changes was decreased (risk ratio = 0.58, 95% CI: 0.38–0.91; with significant P value).
Culver et al.  noted that there was a statistical difference in the incidence of persistent moderate to severe variable deceleration between the two groups, being higher (22%) in the Foley/oxytocin group than the misoprostol (5%), with significant P value. This could be attributed to the concurrent use of oxytocin and its administration dose.
This study showed no statistically significant difference between the two groups regarding the Apgar scores at 1 and 5 min.
Hill et al.  have compared Apgar scores in both groups and reported that both groups were similar in the view of the first and fifth minutes neonatal Apgar score. Similar results were also reported by Moraes Filho et al.  and Roudsari et al. .
Similarly, Abramovici et al.  had compared Apgar scores in both groups with no statistical significant difference.
| Conclusion|| |
A combination of the Foley catheter and vaginal misoprostol resulted in a shorter induction-to-delivery time when compared with vaginal misoprostol alone without increasing labor complications.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]