|Year : 2018 | Volume
| Issue : 1 | Page : 18-22
Comparison between transcervical Foley catheter with oxytocin versus oxytocin alone in inducing labor in women with an unfavorable cervix
Medhat E Helmya1, Said A Saleh1, Nabih I Elkhouly1, Amany M Mosa2
1 Department of Obstetrics and Gynecology, Menoufia University, Menoufia, Egypt
2 Department of Obstetrics and Gynecology, Basyoun Central Hospital, Basyoun, Egypt
|Date of Submission||26-Sep-2016|
|Date of Acceptance||02-Dec-2016|
|Date of Web Publication||14-Jun-2018|
Amany M Mosa
Department of Obstetric and Gynecology, Basyoun Central Hospital, Basyoun, Gharbia 32511
Source of Support: None, Conflict of Interest: None
The aim of our study is to compare the benefit of the use of transcervical Foley catheter with oxytocin if needed and oxytocin alone in inducing labor.
The use of a transcervical balloon catheter for cervical ripening is considered to be a safe and effective method.
Patients and methods
Overall, 72 patients with unfavorable cervix needing induction of labor after 35 weeks of gestational age were enrolled in our study from the Department of Obstetrics and Gynecology of Basyoun Central Hospital between November 2014 and October 2015. Patients were randomly allocated into two groups: group 1 (n = 36) patients were assigned for transcervical Foley catheter with oxytocin infusion, if needed, in case of inefficient cervix dilation by 3 cm, and group 2 (n = 36) patients received oxytocin alone.
There was a statistically significant difference between group 1 and group 2 regarding successful induction, dose, and duration of oxytocin used. There was no statistical difference between both the groups regarding maternal or fetal complications.
Transcervical Foley catheter is probably the most useful method for ripening of cervix before induction of labor. Using transcervical Foley catheter with oxytocin had the highest rate of successful induction with least dose and duration of oxytocin required. No fetal or maternal complications occurred.
Keywords: oxytocin, induction of labor, transcervical Foley catheter, unfavorable cervix
|How to cite this article:|
Helmya ME, Saleh SA, Elkhouly NI, Mosa AM. Comparison between transcervical Foley catheter with oxytocin versus oxytocin alone in inducing labor in women with an unfavorable cervix. Menoufia Med J 2018;31:18-22
|How to cite this URL:|
Helmya ME, Saleh SA, Elkhouly NI, Mosa AM. Comparison between transcervical Foley catheter with oxytocin versus oxytocin alone in inducing labor in women with an unfavorable cervix. Menoufia Med J [serial online] 2018 [cited 2018 Jul 18];31:18-22. Available from: http://www.mmj.eg.net/text.asp?2018/31/1/18/234222
| Introduction|| |
Labor is a process in which the fetus moves from the intrauterine to the extrauterine environment. It is a clinical diagnosis defined as initiation of uterine contractions with the goal of producing cervical effacement and dilatation. The exact mechanisms responsible for this process are currently not well understood . Sometimes, it is necessary to induce labor artificially because of safety concerns for the mother or the baby .
Indications for labor induction can be divided into maternal and fetal indications. These include hypertensive disorders with pregnancies such as pre-eclampsia/eclampsia and other medical disorders such as pregestational and gestational diabetes, chronic pulmonary and renal diseases, chorioamnionitis, intrauterine growth restriction, postdates pregnancies, isoimmunization, and fetal anomalies .
Agents used in cervical ripening include extra-amniotic Foley catheter, hygroscopic dilator, oxytocin, relaxin, sweeping of membranes, estrogen gel, and prostaglandins (PGE2 and PGF2a) . These can be categorized into mechanical methods (e.g., Foley catheter dilatation, laminaria tents, and sweeping of membranes) and the pharmacologic ones (e.g., estrogen, oxytocin, and prostaglandins) .
The use of the transcervical Foley catheter has been shown to be an efficient and reversible method to induce labor .
Oxytocin is commonly administered to induce or augment labor. Although data are sparse, oxytocin infusion during labor appears to have become a routine procedure in developed countries . Although oxytocin is widely accepted as a safe and effective initiator of uterine contractions, its success depends on the preinduction cervical score .
Induction of labor with a Foley catheter is as effective as induction with intravaginal prostaglandin E2 gel with fewer maternal and neonatal adverse effects. The cesarean section (CS) rate was comparable, and a meta-analysis of three trials on the subject of Foley catheter revealed a lower rate of hyperstimulation, resulting in fewer cases of asphyxia and less postpartum hemorrhage. Consequently, the transcervical Foley catheter was recommended for the induction of labor in women with an unfavorable cervix at term .
| Patients and Methods|| |
This study was conducted at the Department of Obstetrics and Gynecology at Basyoun Central Hospital from November 2014 to October 2015. After local ethics committee approval (provided by the hospital) and written informed consent, the study was conducted on 72 pregnant women. This was a prospective, randomized (by simple random sample), controlled, double-blinded study. The inclusion criteria were as follows: pregnancy with a single viable fetus with cephalic presentation; gestational age from 35 to 42 weeks with an indication for labor induction; unfavorable cervix, which is defined as Bishop score less than or equal to 5 ; and parity less than 5. The exclusion criteria were as follows: maternal causes as any contraindication to vaginal delivery, previous uterine scar, suspected chorioamnionitis, unexplained vaginal bleeding, or placenta previa, and fetal causes as fetal malpresentation, multiple gestations, polyhydramnios, cephalopelvic disproportion, and fetal weight greater than or equal to 4500 g.
The sample sizing assumed that the expected percentage response in the use of Foley catheter with oxytocin if needed is 81% and in the use of oxytocin alone is 64% . To achieve a confidence interval of 95% with 80% power, the sample was estimated using Epi-Info (Atlanta, Georgia, US). Cases were divided into two groups using a random sequence; each group included 36 patients. Group 1 had patients assigned to transcervical Foley catheter. The pregnant women were seated on the examination table and instructed to lie in a lithotomy position. After cleaning of the vulva and vagina with antiseptic solution, Cusco's speculum was inserted into the vagina, and Foley catheter gripped with forceps was inserted through the cervical canal into the extra-amniotic space until it is placed above the internal os. Subsequently, the catheter balloon was inflated with sterile normal saline till the patients reported pain, and then the volume was reduced gradually till the pain ceased. The catheter was pulled down (by gentle traction) to be under strain, and then the distal end of the catheter was fixed to the medial aspect of the woman's thigh with adhesive tape. Blood stream (BS) was reassessed when the catheter was expelled or after 12 h. Amniotomy was done when the cervix became dilated by more than 3 cm, and oxytocin infusion was started if uterine contraction was inefficient (<3 contractions/min). Infusion was started with a dose of 5 mU/min (10 drops/min of 5 IU of oxytocin in 500-ml glucose 5%) and augmented with 2.5 mU (five drops/min) every 30 min till adequate contractions was obtained (three uterine contractions in 10 min, each lasting 40–60 s) as recommended by the American College of Obstetrics and Gynecology (1995), and this maintenance dose was continue till delivery. The maximum dose is 30 mU/min) 60 drops/min) to achieve adequate contraction pattern. The fetal heart rate and pattern and uterine contractions were monitored using Cardiotocography (CTG). If after 12 h labor did not progress to the active phase (defined as the cervix being dilated by least 3 cm), induction was considered as failed, as Caughey et al.  defined failed induction of labor (IOL) as the inability to achieve cervical dilatation greater than 4 cm after 12 ± 3 h of oxytocin administration (with a goal of 200–225 MVU or 3 contractions/10 min).
Group 2 patients received intravenous oxytocin infusion alone with the same dose mentioned in group 1.
Tachysystole was defined as six or more contractions in a 10-min period for two consecutive 10-min period .
Failure to progress was diagnosed when there was no cervical change for 4 or more hours of adequate contractions or 6 or more hours of inadequate contractions .
Fetal distress was defined as a heart rate greater than 160/min or < 120/min between uterine contractions with or without meconium stained liquor .
The outcome variables were maternal age, parity, estimated gestational age, indication for induction, initial Bishop's score, dose and duration of oxytocin required, route of delivery, neonatal complications, tachysystole, and uterine rupture.
The statistical presentations of this study were conducted using range, mean ± SD, frequencies, and percentages. Student t-test was used to compare quantitative variables between the study groups for independent samples. For comparing categorical data, χ2-test was performed. Fisher exact probability test was used when the expected frequency was less than 5.P less than 0.05 was considered statistically significant. All statistical calculations were done using computer programs.
| Result|| |
Our study showed no significant difference regarding demographic criteria, initial bishop score, and indication of induction (P > 0.05) [Table 1].
|Table 1: Number and percent distribution of the studied groups regarding their characteristics|
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Successful induction of labor was significantly higher in group 1 than in group 2, as 83.3% of cases in group 1 delivered vaginally compared with 58.3% in group 2. In group 1, six (16.7%) pregnant women delivered through CS compared with 15 (41.7%) in group 2. The duration of oxytocin required till delivery was significantly shorter in group 1 than in group 2 (8.62 ± 2.06 vs. 11.86 ± 1.57 h, respectively), and the mean dose of oxytocin in group 1 was significantly lower than in group 2 (10.98 ± 5.69 and 21.73 ± 3.34 IU, respectively) [Table 2].
The indications of CS were either failed induction [four (11.1%) in group 1 and 10 (27.8%) in group 2], failure to progress [only one (2.8%) in group 1 and three (8.3%) in group 2], or fetal distress [one (2.8%) in group 1 and two (5.6%) in group 2]. The aforementioned results had no statistically significant difference (P > 0.05) [Table 3].
The present study showed no statistically significant difference between the two groups regarding the mean Apgar scores at 1 min (8.44 ± 1.20 in group 1 and 8.75 ± 1.27 in group 2). Moreover, there was no significant difference between the two groups regarding the Apgar scores even at 5 min (9.75 ± 0.60 in group 1 and 9.66 ± 0.98 in group 2). There was no difference regarding other neonatal outcomes analyzed in the present study, which are follows: mean birth weight (3.21 ± 0.50 kg for group 1 and 3.22 ± 0.41 kg for group 2; P > 0.05), oxygen supplementation (13.9% in group 1 and 8.3% in group 2), and neonates needing positive pressure ventilation (PPV) (one case in group 1 and two cases in group 2) [Table 4].
There was no statistically significant difference between the groups (P > 0.05) regarding the secondary outcome measures in the present study, which represent the occurrence of complications with the use of any of the treatment modalities: uterine tachysystole happened in one case in group 1 only, postpartum hemorrhage occurred in two cases in group 2, cervical tear occurred in two cases in group 2, and postpartum pyrexia occurred in one case each in group 1 and group 2. Neither uterine rupture nor chorioamnionitis occurred in any of the studied groups [Table 5].
|Table 5: Distribution of the studied groups regarding maternal complications|
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| Discussion|| |
This study was a prospective randomized clinical trial that compared the efficacy and safety of Foley catheter for induction of labor in women with an unfavorable cervix. The first group (n = 36) used a mechanical method, referring to the transcervical Foley's catheter with a balloon filled with sterile normal saline with oxytocin if needed, whereas the second group (n = 36) used a pharmacological method, comprising intravenous infusion of oxytocin alone.
The two groups had similar demographic and antepartum variables – maternal age, gestational age, parity, an indication of labor induction, and initial Bishop score – with no statistically significant difference. The indications for labor induction among pregnant women in the present study were similar to those reported by Bujold et al. , Owolabi et al. , Cromi et al. , and Trabelsi et al.  in their studies. Post-term pregnancy was the most common indication of labor induction and then pre-eclampsia, but they were different from those reported in other studies such as Meetei et al. who reported that the most common indications were oligohydramnios and postdatism.
The current study found that the use of transcervical Foley catheter with oxytocin if needed owing to slippage of the catheter had an advantage over the other group using oxytocin alone. This is proved by many factors.
First, successful induction was significantly higher in group 1 than in group 2, as 83.3% of cases delivered vaginally in group 1 and 58.3% in group 2. Moreover, six (16.7%) pregnant women in group 1 delivered through CS compared with 15 (41.7%) in group 2. This result was in agreement with the study by Meetei et al. , in which 66.7% of the patients in the group with Foley catheter followed by oxytocin delivered vaginally versus 60% of those in oxytocin group. Moreover, in the study by Elsadig et al. , nine (25.7%) cases had lower segment CS compared with 20 (57.1%) cases in the oxytocin group. However, Ferradas et al. study found no significant difference between group using Foley catheter or oxytocin regarding vaginal delivery (64.6 and 56.3%, respectively).
The second factor proving that transcervical Foley catheter group had the advantages over the oxytocin group alone was the duration of oxytocin required till delivery, which was significantly shorter in group 1 (8.62 ± 2.06 h in group 1 vs. 11.86 ± 1.57 h in group 2). This result might be attributed to the fact that mechanical methods ripen the cervix through direct dilatation of the canal or indirectly by increasing prostaglandin and/or oxytocin secretion . In agreement with our study, study by Ferradas et al.  found that the duration of oxytocin required till delivery was significantly shorter in the group using balloon device than in the group using oxytocin alone. It was 10. 33 and 14.25 h in Foley catheter followed by oxytocin and oxytocin group.
The third factor was the mean dose of oxytocin used till delivery, as it was significantly lower in group 1 than in group 2 (10.98 ± 5.69 and 21.73 ± 3.34 IU, respectively); however, this result was not in agreement with the study of Meetei et al. , which found no significant difference in the dose of oxytocin required between Foley catheter followed by oxytocin (25.16 IU) and oxytocin alone (21.37 IU) groups.
In the current study, the indications of CS were either failed induction [four (11.1%) in group 1 and 10 (27.8%) in group 2], failure to progress [only one (2.8%) case in group 1 and three (8.3%) cases in group 2], or fetal distress [one (2.8%) case in group 1 and two (5.6%) cases in group 2]. The aforementioned results had no statistically significant differences (P > 0.05). More or less similar result of no statistical difference between the groups regarding the route of delivery was also presented by the study by Meetei et al. , which also reported that the most common indication was nonprogress of labor in Foley group and fetal distress in oxytocin group. Other indications were cervical dystocia and deep transverse arrest; these differences were not statistically significant.
There was no statistically significant difference regarding the neonatal outcome or maternal complication. Ferradas et al.  and Meetei et al.  had comparable results, with no statistically significant differences.
| Conclusion|| |
Transcervical Foley catheter is probably the most useful method for ripening of cervix before starting induction of labor. Using transcervical Foley catheter and oxytocin if needed has the highest rate of successful induction, with least dose and duration of oxytocin required. Usage of transcervical Foley catheter or oxytocin shows comparable safety for the mother and the fetus.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Tenore J. Methods for cervical ripening and induction of labor. Am Fam Physician 2003; 67
Hofmeyer GJ, Gulmezogla AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labor. (review). Cochrane Database Syst Rev 2010; 10
Wing DA. Symposium in cervical ripening and induction of labor. Clin Obstet Gynecol 2006; 49
Owolabi AT, Kuti O, Ogunlola IO. Randomized trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labor. J Obstet Gynecol 2005; 25
Niromance S, Mousavi-Jarrahi A, Samkhaniani F. Intracervical Foley catheter balloon vs. prostaglandin in pre-induction cervical ripening. Int J Gynecol Obstet 2003; 81
Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol 2006; 49
Belghiti J, Kayem G, Dupont C. Oxytocin during labor and risk of severe postpartum hemorrhage. BMJ Open 2011; 1
Promila J, GB Kaur, T Bala. Comparison of vaginal misoprostol versus Foley's catheter with oxytocin for induction of labor. J Obstet Gynecol India 2007; 57
Jozwiak M, Oude RK, Benthem M, van BE, Dijksterhuis MG, de Graaf IM, et al.
Foley catheter versus vaginal prostaglandin E2 gel for induction of labor at term (PROBAAT trial). BJOG 2013; 120
Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labor. Cochrane Database Syst Rev 2001; 4
Ferradas ER, Izaskun LA, Miren AGa, Irene DI, José GA. balloon device compared to oxytocin for induction of labor. J Obstet Gynecol 2013; 3
Caughey AB, Sundaram V, Kaimal AJ, Gienger A, Cheng YW, McDonald KM, et al.
Systematic review: elective induction of labor versus expectant management of pregnancy. Ann Intern Med 2009; 151
Lin MG, Nuthalapaty FS, Carver AR. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol 2005; 106
Spong: Preventing the First Cesarean delivery. Summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol 2012; 120
Souza SW, John RW, Richards B, Milner RD. Fetal distress and birth scores in newborn infants. Arch Dis Child 1975; 50:
Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical Foley catheter and the risk of uterine rupture. Obstet Gynecol 2004; 103
Cromi A, Ghezzi F, Tomera S. Cervical ripening with the Foley catheter. Int J Gynecol Obstet 2007; 97
Trabelsi H, Ben-Ali I, Zayen S. A randomized comparison of transcervical Foley catheter to intravaginal Misoprostol for pre-induction cervical ripening. Presented at the Thirteenth Annual International Conference of the Department of Obstetrics and Gynecology. Cairo, Egypt: Ain Shams University; 2008.
Meetei LT, V Suri, N
Aggarwal. Induction of labor in patients with a previous cesarean section with unfavorable cervix. J Med Soc 2014; 28
Elsadig AH, Mustafa AH, Abdul Hafeez AR. Cervical ripening and induction of labor with foley catheter compared to oxytocin Gezira. J Health Sci 2005;7
Boulvain M, Kelly A, Lohse C. Mechanical methods for induction of labor (review). Cochrane Database Syst Rev 2008;4.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]