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Safety and efficacy of double-balloon catheter for cervical ripening: a Bayesian network meta-analysis of randomized controlled trials

Abstract

Background

Various methods are used for cervical ripening during the induction of labor. Mechanical and pharmacological methods are commonly used for cervical ripening. A double-balloon catheter was specifically developed to ripen the cervix and induce labor; however, the efficacy of the double-balloon catheter in cervical ripening compared to other methods is unknown.

Methods

We searched five databases and performed a Bayesian network meta-analysis. Six interventions (double-balloon catheter, Foley catheter, oral misoprostol, vaginal misoprostol, dinoprostone, and double-balloon catheter combined with oral misoprostol) were included in the search. The primary outcomes were cesarean delivery rate and time from intervention-to-birth. The secondary outcomes were as follows: Bishop score increment; achieving a vaginal delivery within 24 h; uterine hyperstimulation with fetal heart rate changes; need for oxytocin augmentation; instrumental delivery; meconium staining; chorioamnionitis; postpartum hemorrhage; low Apgar score; neonatal intensive care unit admission; and arterial pH.

Results

Forty-eight randomized controlled trials involving 11,482 pregnant women were identified. The cesarean delivery rates of the cervical ripening with a double-balloon catheter and oral misoprostol, oral misoprostol, and vaginal misoprostol were significantly lower than cervical ripening with a Foley catheter (OR = 0.48, 95% CI: 0.23–0.96; OR = 0.74, 95% CI: 0.58–0.93; and OR = 0.79, 95% CI: 0.64–0.97, respectively; all P < 0.05). The time from intervention-to-birth of vaginal misoprostol was significantly shorter than the other five cervical ripening methods. Vaginal misoprostol and oral misoprostol increased the risk of uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. A double-balloon catheter with or without oral misoprostol had similar outcomes, including uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter.

Conclusion

Double-balloon catheter did not show superiority when compared with other single method in primary and secondary outcomes of labor induction. The combination of double-balloon catheter with oral misoprostol was significantly reduced the rate of cesarean section compared to Foley catheter without increased risk of uterine hyperstimulation with fetal heart rate changes, which was shown in oral or vaginal misoprostol.

Peer Review reports

Introduction

Labor induction is a common obstetric procedure; 20 to 30% of deliveries are induced worldwide [1]. Successful induction of labor depends on the status of the cervix at the time of induction. A poor Bishop score has been shown to be associated with an unacceptably high induction failure rate [2]. Medical interventions are necessary to induce cervical ripening prior to initiation of labor if the Bishop score is ≤ 6 [3,4,5].

Methods of cervical ripening can be broadly categorized into mechanical and pharmacological methods [4, 6]. Mechanical methods apply pressure from inside the cervical canal to force dilation. The local pressure stimulates the release of prostaglandins (PGs), which facilitate cervical remodeling. Foley catheters and transcervical double-balloon catheters are the two major devices utilized for mechanical dilation [7]. Compared with the unilateral pressure of a single-balloon catheter, the double-balloon catheter offers an improved mechanism of dilation between the internal and external cervical os [8]. There are a variety of pharmaceutical agents available for cervical ripening, including PGs, oxytocin, estrogens, and mifepristone. PGE2 cervical ripening with controlled-release dinoprostone inserts has gained widespread use in clinical practice. Misoprostol, a synthetic structural analog of PGE1, has been shown to be effective in labor induction and is often used as an off-label drug for inducing labor.

To determine if the double-balloon catheter was better than other methods, recent clinical trials have been designed to compare the efficacy and safety with a Foley catheter [9], dinoprostone insert [10], and misoprostol [11]; however, the results have not led to a consensus. We therefore conducted a network meta-analysis (NMA) comparing the double-balloon catheter with four commonly used cervical ripening in labor induction methods among pregnant women in the third trimester with intact membranes. The purpose of this study was to provide a comprehensive overview of the available evidence involving the use of a double-balloon catheter for cervical ripening in clinical practice.

Methods

The pre-registered protocol was implemented in the PROSPERO database (CRD42022317381). This NMA was reported in accordance with the PRISMA guidelines (Supplemental Table S1).

Search strategy

The PubMed, MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Library databases were searched on March 18, 2022 to identify the relevant studies by two investigators. The keywords in the search strategy were as follows: “cervical ripening” or “labor, induced”; and “double-balloon catheter” or “single-balloon catheter/Foley catheter” or “dinoprostone” or “misoprostol” (Supplemental Table S2). Additionally, we searched the references of articles to further identify literature that met the criteria.

Data extraction and extraction

Original studies were eligible if the following criteria were met: (I) randomized controlled trial (RCT) studies; (II) full text available in English; and (III) the efficacy and safety of different interventions (double-balloon catheter, single balloon catheter/Foley catheter, oral misoprostol, vaginal misoprostol, 10-mg controlled-release dinoprostone vaginal insert, and double-balloon catheter combined with misoprostol/dinoprostone) for cervical ripening in women with an unfavorable cervix and with intact membranes were assessed.

Original studies were ineligible for the following reasons: (I) reviews, observational studies, case control studies, abstracts, letters, or case reports; (II) trials including women whose pregnancies were ≤ 28 weeks gestational age, non-cephalic presentations, multiple pregnancies, or a previous cesarean section(s); (III) other forms of dinoprostone (gel or tablet); or (IV) laboratory animal studies. In the case of several publications from the same study, the study with the greatest number of cases and most relevant information was included.

The first author, year of publication, treatment groups, and number of participants in each group, age (years), nulliparity, gestational age (weeks), balloon volume (mL), misoprostol route and dose, and outcomes were extracted from the eligible studies.

Outcomes

The primary outcomes were cesarean delivery rate and the time from intervention-to-birth. The secondary outcomes included achieving vaginal delivery within 24 h, Bishop score increment, uterine hyperstimulation with fetal heart rate changes, oxytocin augmentation, instrumental delivery, meconium-stained amniotic fluid, maternal adverse events (chorioamnionitis and postpartum hemorrhage), and neonatal adverse events (low Apgar score, neonatal intensive care unit admission, and arterial pH).

Statistical analysis

Prior to analysis, the risk of trial bias was assessed for the included studies using the Cochrane Collaboration’s tool. The mean difference (MD) and 95% confidence interval (CI) were the time from intervention-to-birth and Bishop score increment. Odds ratios (ORs) were used to report the cesarean delivery rate, achieving vaginal delivery within 24 h, uterine hyperstimulation with fetal heart rate changes, oxytocin augmentation, instrumental delivery, and meconium-stained amniotic fluid. We evaluated the efficacy and safety of different interventions for cervical ripening in women with an unfavorable cervix and intact membranes using an NMA. In this Bayesian NMA, random-effects and consistency models were used to analyze data and carry out the NMA (4 chains, 50,000 iterations, and 20,000 per chain). We assessed inconsistencies using the node-splitting method, and inconsistencies are reported by the Bayesian P values. An overall grading of the quality of evidence was conducted using the GRADE system. To rank the outcomes, we used the surface under the cumulative ranking curve (SUCRA) as an indicator (worst: 0; best:1) for each intervention. We analyzed the symmetry of a comparison-adjusted funnel plot to evaluate possible small sample effects and used Begg’s and Egger’s tests to evaluate publication bias in the included studies. A p value < 0.05 was considered statistically significant for asymmetry. All analyses were conducted using the “gemtc” package of R (version 4.0.2; R Foundation, Vienna, Austria) and Stata (version 16.0; StataCorp, College Station, TX, USA).

Results

Baseline characteristics of included studies

Our exhaustive search strategy retrieved 2,981 potentially relevant publications from six databases. After screening and reading the full-text articles, 48 RCTs were included in our final analyses (Fig. 1) [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57]. These RCTs were conducted between 1997 and 2021 (Table 1) and were carried out in Asia (China, India, Iran, Israel, Saudi Arabia, Sri Lanka, Thailand, and Turkey), Australia, Europe (France, Germany, Italy, the Netherlands, and the UK), and North America (the USA and Canada). Six types of intervention were assessed, including oral misoprostol, vaginal misoprostol, dinoprostone, Foley catheter, double-balloon catheter, and double-balloon catheter with oral misoprostol. All of the studies were two-arm with 11,482 pregnant women. The balloon volume, misoprostol dose, and outcomes of each study are shown in Table 1. The evaluation of bias risk for all RCTs is presented in Supplemental Figure S1 and S2.

Fig. 1
figure 1

Flow chart of study selection

Table 1 Characteristics of included studies

Primary outcomes

The cesarean delivery rate in patients who underwent cervical ripening with a double-balloon catheter and oral misoprostol, oral misoprostol, and vaginal misoprostol were significantly lower than a Foley catheter (OR = 0.48, 95% CI: 0.23–0.96; OR = 0.74, 95% CI: 0.58–0.93; and OR = 0.79, 95% CI: 0.64–0.97, respectively; all P < 0.05; Fig. 2, Supplemental Table S3). The time from intervention-to-birth of vaginal misoprostol was significantly shorter than the other five interventions (Fig. 2, Supplemental Table S4).

Fig. 2
figure 2

Forest plots of network meta-analysis of all trials for primary and secondary outcomes

Secondary outcomes

All of the head-to-head comparisons are shown in Supplemental Table S5–S16. Compared to a Foley catheter, vaginal misoprostol resulted in a higher incremental change in the Bishop score (MD = 2.80, 95% CI: 0.55–5.08) and lower rate of oxytocin augmentation (OR = 0.14, 95% CI: 0.094–0.21), but a higher risk of uterine hyperstimulation with fetal heart rate changes (OR = 7.72, 95% CI: 2.44–41.59).

Compared to a Foley catheter, oral misoprostol had a lower rate of oxytocin augmentation (OR = 0.29, 95% CI: 0.18–0.46), but a higher risk of uterine hyperstimulation with fetal heart rate changes (OR = 4.30, 95% CI: 1.08–29.56) and a higher rate of meconium-stained amniotic fluid (OR = 1.73, 95% CI: 1.09–3.32).

Compared to a Foley catheter, a double-balloon catheter with or without oral misoprostol had similar outcomes, including uterine hyperstimulation with fetal heart rate changes (OR = 4.75, 95% CI: 0.26–294.50).

No difference in achieving vaginal delivery within 24 h, instrumental delivery, chorioamnionitis, postpartum hemorrhage, neonatal intensive care unit admission, and arterial pH among these interventions were revealed (Supplemental Tables S5, S9, S11, S12, S15, and S16).

Network geometry, inconsistency, certainty of evidence, and publication bias

Network geometry is shown in Supplemental Figure S3. The evaluation of inconsistencies for all outcomes are presented in Supplemental Figures S4-S16. We noted a significance level (P > 0.05) for most cases, which indicated that inconsistency was not sufficient to influence the conclusion of this NMA. According to the SUCRA value, ranking of all interventions was done (Fig. 3). Finally, we used the GRADE system to evaluate the certainty of evidence (Table 2). No significant asymmetry was demonstrated in the funnel plot of major primary and secondary outcomes (Supplemental Figures S17 and S18). The results of Begg’s and Egger’s tests are shown in Supplemental Table S17.

Fig. 3
figure 3

Heat maps of cervical ripening interventions for 14 Outcomes. Each column represents a cervical ripening intervention, and each row represents an outcome. Each box is colored according to the SUCRA value of the corresponding intervention and outcome. The color scale consists of values that represent SUCRA which range from 0 (white, indicating a treatment is always last) to 1 (purple, indicating a treatment is always first). Uncolored boxes labeled “NA” show that the underlying treatment was not included for that particular outcome. The values in each box represent the SUCRA value of the corresponding treatment and outcome. NA, not applicable; SUCRA: surface under the cumulative ranking curve

Table 2 Summary of the results of NMA and GRADE quality score assessment for the outcomes

Discussion

This NMA provides evidence for the relative efficacy and safety of double-balloon catheters for cervical ripening. A large amount of evidence was pooled to allow us to indirectly compare the clinical efficacy and safety profile of a double-balloon catheter with a Foley catheter, misoprostol (oral/vaginal), and a controlled-release dinoprostone insert for cervical ripening and labor induction in women with unfavorable cervices during the third trimester of pregnancy. These five methods are commonly used for cervical ripening. Our analysis demonstrated that the double-balloon catheter was not superior to other methods with respect to the cesarean section rate, time from intervention-to-birth, and maternal and neonatal adverse events. The combined use of a double-balloon catheter and oral misoprostol significantly reduced the cesarean section rate compared to a Foley catheter without an increased risk of uterine hyperstimulation with fetal heart rate changes, as occurred with oral or vaginal misoprostol alone.

To ripen the cervix, a number of methods are used; however, there is little consensus regarding which method is best [58]. It has been suggested that catheter balloons were equally effective in cervical ripening as pharmacological methods, with no significant differences in mode of delivery or perinatal outcome [59]. The double-balloon catheter was specifically developed for inducing labor. The mechanism of action by which the double-balloon catheter ripens the cervix is achieved by pressure applied to the external and internal os. The vaginal balloon is used to hold the balloon in the extra-amniotic space during cervix softening and distensibility. As the ripening process continues, the device can spontaneously expel itself early [8].

Previous systematic reviews on the safety and effectiveness of double-balloon catheters have been published; however, these reviews have been limited to pairwise meta-analyses [60,61,62,63]. In contrast, NMAs provide an important method of including a large amount of direct and indirect evidence from comparisons of many different interventions. In this NMA, we did not demonstrate an advantage to the double-balloon to other single method in various primary and secondary outcomes of labor induction. When combined with oral misoprostol, the double-balloon catheter was shown to reduce the cesarean delivery rate compared with a Foley catheter. Vaginal misoprostol alone improved the outcomes of labor induction, including the cesarean section rate, time from intervention-to-birth, Bishop score increment, and oxytocin augmentation. Even though vaginal misoprostol alone appeared to be the most effective method in cervical ripening, use of vaginal misoprostol was associated with the highest incidence of uterine hyperstimulation with fetal heart rate changes. Oral misoprostol was shown to have similar efficiency and safety to vaginal misoprostol in our analysis. The resulting uterine hyperstimulation with misoprostol use is consistent with previous studies [52, 64, 65]. Interestingly, uterine hyperstimulation with fetal heart rate changes did not occur with a double-balloon catheter combined with oral misoprostol. This finding may be due to the additional cervical dilation effect of the double-balloon catheter. This effect could reduce the misoprostol dose and the risk of uterine hyperstimulation [66].

Unlike previous studies [60, 63], we did not find any difference in Bishop score improvement between double-balloon and Foley catheters. Chorioamnionitis is a major concern when double-balloon catheters are used. According to our analysis, there were no significant difference in chorioamnionitis between a double-balloon catheter and any other method. Although there was a higher proportion of 5-min Apgar scores < 7 with double-balloon catheter and oral misoprostol use, there were only a few cases and there were no differences in umbilical artery pH, thus this finding was not clinically relevant. Therefore, this NMA indicated that the combination of a double-balloon catheter with oral misoprostol may be a preferable choice in view of the reduction in the cesarean section rate and lack of significant adverse outcomes.

Our analysis evaluated the safety and efficacy of double-balloon catheters. The combined effect of a double-balloon catheter with other cervical ripening methods was also included in our study. However, we did not identify any randomized controlled trial to assess the combined effect of controlled-release dinoprostone and a double-balloon catheter, although this combination may improve the induction outcome much like the combined effect with misoprostol. The high cost of controlled-release dinoprostone and a double-balloon catheter should be the reason. We did not perform an NMA to compare the combined effect of a Foley catheter with other cervical ripening methods in the present study. Because safety and efficacy was similar between double-balloon and Foley catheters, whether a Foley catheter combined with misoprostol has the same effect needs to be confirmed. It should be noted that a Foley catheter is much less expensive than a double-balloon catheter. In fact, use of a Foley catheter is a classic mechanical method for cervical ripening and widely used in low-resource settings [55, 67]. Among developing countries where health-related costs are a major concern, a Foley catheter is recommended as a better option than other cervical ripening methods.

Strengths

One of the strengths of our review was the application of an NMA. Our NMA was strictly confined to randomized trials and provided comprehensive comparisons between a double-balloon catheter and five other cervical ripening techniques, which increased the interpretation of the existing evidence. We calculated the probabilities of ranking cervical ripening methods using Bayesian analysis. Furthermore, to minimize potential bias due to the variation in the characteristics of the included women, we applied several restrictions for inclusion in the review. Specifically, we excluded studies that included outpatients or pregnant women who were in the second trimester. Third, only few included trials were of low quality. Moreover, our protocol was registered with PROSPERO before data abstraction commenced.

Future directions

First, because a Foley catheter is much less expensive than a double-balloon catheter, trials aimed to compare the efficacy of “the combination of a Foley catheter with misoprostol” and “the combination of a double-balloon catheter with misoprostol” needs to be conducted. Second, compared with inpatient management, women may be able to find better psychological and social support at home. Therefore, the safety of outpatient cervical priming of a double-balloon catheter also needs to be confirmed. Third, only one trial compared a double-balloon catheter with oral misoprostol to oral misoprostol alone [11], thus additional evidence is needed.

Limitation

The current meta-analysis had some limitations. First, to decrease the heterogeneity, we only included trials with the dinoprostone formulation that was most often used in the trials compared with a double-balloon catheter. Second, the misoprostol dose and the volume of the double-balloon or Foley catheter were variable, which may affect the credibility of the conclusion. Third, the characteristics of the participants, such as maternal age, parity, gestational age, body mass index, baseline Bishop score, and labor induction, were diverse and underlying confounders. Fourth, some of the involved trials were not double-blinded due to the nature of the intervention.

Conclusion

The clinical outcomes were similar between a double-balloon catheter alone and other single methods. For pregnant women with intact membranes after 28 weeks gestation, vaginal misoprostol was shown to be the most effective methods for cervical ripening with respect to the cesarean delivery rate, time from intervention-to-birth, and oxytocin augmentation; however, vaginal misoprostol was associated with higher rates of uterine hyperstimulation with fetal heart rate changes. The combination of a double-balloon catheter with oral misoprostol was the best method to reduce the likelihood of delivery by cesarean section without uterine hyperstimulation with fetal heart rate changes. 

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

CI:

Confidence interval

MD:

Mean difference

NMA:

Network meta-analysis

OR:

Odds ratio

RCT:

Randomized controlled trial

SUCRA:

Surface under the cumulative ranking curve

References

  1. West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017;6:CD009792.

    PubMed  Google Scholar 

  2. Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999;180(1 Pt 1):55–60.

    CAS  PubMed  Article  Google Scholar 

  3. Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003;67(10):2123–8.

    PubMed  Google Scholar 

  4. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009;114(2 Pt 1):386–97.

    Google Scholar 

  5. Marroquin GA, Tudorica N, Salafia CM, Hecht R, Mikhail M. Induction of labor at 41 weeks of pregnancy among primiparas with an unfavorable Bishop score. Arch Gynecol Obstet. 2013;288(5):989–93.

    CAS  PubMed  Article  Google Scholar 

  6. Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012;(3):CD001233. https://doi.org/10.1002/14651858.CD001233.pub2.

  7. Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006;49(3):642–57.

    PubMed  Article  Google Scholar 

  8. Atad J, Hallak M, Ben-David Y, Auslender R, Abramovici H. Ripening and dilatation of the unfavourable cervix for induction of labour by a double balloon device: experience with 250 cases. Br J Obstet Gynaecol. 1997;104(1):29–32.

    CAS  PubMed  Article  Google Scholar 

  9. Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021;34(7):1034–41.

    PubMed  Article  Google Scholar 

  10. Diguisto C, Le Gouge A, Arthuis C, Winer N, Parant O, Poncelet C, Chauleur C, Hannigsberg J, Ducarme G, Gallot D, et al. Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021;18(2):e1003448.

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  11. Kehl S, Ziegler J, Schleussner E, Tuschy B, Berlit S, Kirscht J, Hagele F, Weiss C, Siemer J, Sutterlin M. Sequential use of double-balloon catheter and oral misoprostol versus oral misoprostol alone for induction of labour at term (CRBplus trial): a multicentre, open-label randomised controlled trial. BJOG. 2015;122(1):129–36.

    CAS  PubMed  Article  Google Scholar 

  12. Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol. 1997;177(3):612–8.

    CAS  PubMed  Article  Google Scholar 

  13. Bennett KA, Butt K, Crane JM, Hutchens D, Young DC. A masked randomized comparison of oral and vaginal administration of misoprostol for labor induction. Obstet Gynecol. 1998;92(4 Pt 1):481–6.

    CAS  PubMed  Google Scholar 

  14. Wing DA, Ham D, Paul RH. A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction. Am J Obstet Gynecol. 1999;180(5):1155–60.

    CAS  PubMed  Article  Google Scholar 

  15. Fisher SA, Mackenzie VP, Davies GA. Oral versus vaginal misoprostol for induction of labor: a double-blind randomized controlled trial. Am J Obstet Gynecol. 2001;185(4):906–10.

    CAS  PubMed  Article  Google Scholar 

  16. Khoury AN, Zhou QP, Gorenberg DM, Nies BM, Manley GE, Mecklenburg FE. A comparison of intermittent vaginal administration of two different doses of misoprostol suppositories with continuous dinoprostone for cervical ripening and labor induction. J Matern Fetal Med. 2001;10(3):186–92.

    CAS  PubMed  Article  Google Scholar 

  17. Kwon JS, Davies GAL, Mackenzie VP. A comparison of oral and vaginal misoprostol for induction of labour at term: a randomised trial. Br J Obstet Gynaecol. 2001;108(1):23–6.

    CAS  Google Scholar 

  18. Sciscione AC, Nguyen L, Manley J, Pollock M, Maas B, Colmorgen G. A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening. Obstet Gynecol. 2001;97(4):603–7.

    CAS  PubMed  Google Scholar 

  19. Shetty A, Danielian P, Templeton A. A comparison of oral and vaginal misoprostol tablets in induction of labour at term. Br J Obstet Gynaecol. 2001;108(3):238–43.

    CAS  Google Scholar 

  20. le Roux PA, Olarogun JO, Penny J, Anthony J. Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial. Obstet Gynecol. 2002;99(2):201–5.

    PubMed  Google Scholar 

  21. Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol–Foley catheter for labor induction. Am J Obstet Gynecol. 2003;189(4):1031–5.

    CAS  PubMed  Article  Google Scholar 

  22. Nopdonrattakoon L. A comparison between intravaginal and oral misoprostol for labor induction: a randomized controlled trial. J Obstet Gynaecol Res. 2003;29(2):87–91.

    CAS  PubMed  Article  Google Scholar 

  23. Ramsey PS, Harris DY, Ogburn PL Jr, Heise RH, Magtibay PM, Ramin KD. Comparative efficacy and cost of the prostaglandin analogs dinoprostone and misoprostol as labor preinduction agents. Am J Obstet Gynecol. 2003;188(2):560–5.

    CAS  PubMed  Article  Google Scholar 

  24. Shetty A, Livingstone I, Acharya S, Rice P, Danielian P, Templeton A. Oral misoprostol (100 microg) versus vaginal misoprostol (25 microg) in term labor induction: a randomized comparison. Acta Obstet Gynecol Scand. 2003;82(12):1103–6.

    PubMed  Article  Google Scholar 

  25. Paungmora N, Herabutya Y. P OP, Punyavachira P: Comparison of oral and vaginal misoprostol for induction of labor at term: a randomized controlled trial. J Obstet Gynaecol Res. 2004;30(5):358–62.

    CAS  PubMed  Article  Google Scholar 

  26. Rozenberg P, Chevret S, Senat MV, Bretelle F, Paule Bonnal A, Ville Y. A randomized trial that compared intravaginal misoprostol and dinoprostone vaginal insert in pregnancies at high risk of fetal distress. Am J Obstet Gynecol. 2004;191(1):247–53.

    CAS  PubMed  Article  Google Scholar 

  27. Adeniji OA, Oladokun A, Olayemi O, Adeniji OI, Odukogbe AA, Ogunbode O, Aimakhu CO, Omigbodun AO, Ilesanmi AO. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. J Obstet Gynaecol. 2005;25(2):134–9.

    CAS  PubMed  Article  Google Scholar 

  28. Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005;89(3):263–7.

    CAS  PubMed  Article  Google Scholar 

  29. Gelisen O, Caliskan E, Dilbaz S, Ozdas E, Dilbaz B, Ozdas E, Haberal A. Induction of labor with three different techniques at 41 weeks of gestation or spontaneous follow-up until 42 weeks in women with definitely unfavorable cervical scores. Eur J Obstet Gynecol Reprod Biol. 2005;120(2):164–9.

    CAS  PubMed  Article  Google Scholar 

  30. Owolabi AT, Kuti O, Ogunlola IO. Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. J Obstet Gynaecol. 2005;25(6):565–8.

    CAS  PubMed  Article  Google Scholar 

  31. Ayaz A, Saeed S, Farooq MU, Ahmad I, Bahoo MLA, Saeed M. Labor induction with randomized comparison of oral and intravaginal misoprostol in post date multigravida women. Malaysian J Med Sci. 2009;16(1):25–30.

    Google Scholar 

  32. Ozkan S, Caliskan E, Doger E, Yucesoy I, Ozeren S, Vural B. Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. Arch Gynecol Obstet. 2009;280(1):19–24.

    PubMed  Article  CAS  Google Scholar 

  33. Pennell CE, Henderson JJ, O’Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009;116(11):1443–52.

    CAS  PubMed  Article  Google Scholar 

  34. Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011;204(4):338 e331-337.

    Article  Google Scholar 

  35. Roudsari FV, Ayati S, Ghasemi M, Mofrad MH, Shakeri MT, Farshidi F, Shahabian M. Comparison of vaginal misoprostol with foley catheter for cervical ripening and induction of labor. Iran J Pharm Res. 2011;10(1):149–54.

    Google Scholar 

  36. Salim R, Zafran N, Nachum Z, Garmi G, Kraiem N, Shalev E. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol. 2011;118(1):79–86.

    PubMed  Article  Google Scholar 

  37. Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012;207(2):125 e121-127.

    Article  CAS  Google Scholar 

  38. Kandil M, Emarh M, Sayyed T, Masood A. Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations. Arch Gynecol Obstet. 2012;286(2):303–7.

    PubMed  Article  Google Scholar 

  39. Jozwiak M, Oude Rengerink K, Ten Eikelder ML, van Pampus MG, Dijksterhuis MG, de Graaf IM, van der Post JA, van der Salm P, Scheepers HC, Schuitemaker N, et al. Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):137–45.

    CAS  PubMed  Article  Google Scholar 

  40. Ugwu EO, Onah HE, Obi SN, Dim CC, Okezie OA, Chigbu CO, Okoro OS. Effect of the Foley catheter and synchronous low dose misoprostol administration on cervical ripening: a randomised controlled trial. J Obstet Gynaecol. 2013;33(6):572–7.

    CAS  PubMed  Article  Google Scholar 

  41. Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014;123(6):1280–7.

    CAS  PubMed  Article  Google Scholar 

  42. Jozwiak M, Ten Eikelder M, Rengerink KO, De Groot C, Feitsma H, Spaanderman M, Van Pampus M, De Leeuw JW, Mol BW, Bloemenkamp K. Foley catheter versus vaginal misoprostol: Randomized controlled trial (PROBAAT-M Study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014;31(2):145–55.

    PubMed  Google Scholar 

  43. Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med. 2014;42(2):213–8.

    CAS  PubMed  Article  Google Scholar 

  44. Wang W, Zheng J, Fu J, Zhang X, Ma Q, Yu S, Li M, Hou L. Which is the safer method of labor induction for oligohydramnios women? Transcervical double balloon catheter or dinoprostone vaginal insert. J Matern Fetal Neonatal Med. 2014;27(17):1805–8.

    PubMed  Article  Google Scholar 

  45. Chavakula PR, Benjamin SJ, Abraham A, Londhe V, Jeyaseelan V, Mathews JE. Misoprostol versus Foley catheter insertion for induction of labor in pregnancies affected by fetal growth restriction. Int J Gynaecol Obstet. 2015;129(2):152–5.

    CAS  PubMed  Article  Google Scholar 

  46. Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015;291(6):1221–7.

    PubMed  Article  Google Scholar 

  47. Ezechukwu PC, Ugwu EO, Obi SN, Chigbu CO. Oral versus vaginal misoprostol for induction of labor in Enugu, Nigeria: a randomized controlled trial. Arch Gynecol Obstet. 2015;291(3):537–44.

    PubMed  Article  Google Scholar 

  48. Noor N, Ansari M, Ali SM, Parveen S. Foley Catheter versus Vaginal Misoprostol for Labour Induction. Int J Reprod Med. 2015;2015:845735.

    PubMed  PubMed Central  Article  Google Scholar 

  49. Shechter-Maor G, Haran G, Sadeh-Mestechkin D, Ganor-Paz Y, Fejgin MD, Biron-Shental T. Intra-vaginal prostaglandin E2 versus double-balloon catheter for labor induction in term oligohydramnios. J Perinatol. 2015;35(2):95–8.

    CAS  PubMed  Article  Google Scholar 

  50. Hoppe KK, Schiff MA, Peterson SE, Gravett MG. 30 mL Single- versus 80 mL double-balloon catheter for pre-induction cervical ripening: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(12):1919–25.

    PubMed  Article  Google Scholar 

  51. Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016;42(11):1489–94. https://doi.org/10.1111/jog.13086.

    CAS  Article  PubMed  Google Scholar 

  52. Ten Eikelder ML, Mast K, van der Velden A, Bloemenkamp KW, Mol BW. Induction of Labor Using a Foley Catheter or Misoprostol: A Systematic Review and Meta-analysis. Obstet Gynecol Surv. 2016;71(10):620–30.

    PubMed  Article  Google Scholar 

  53. Yenuberi H, Abraham A, Sebastian A, Benjamin SJ, Jeyaseelan V, Mathews JE. A randomised double-blind placebo-controlled trial comparing stepwise oral misoprostol with vaginal misoprostol for induction of labour. Trop Doct. 2016;46(4):198–205. https://doi.org/10.1177/0049475515624856.

    Article  PubMed  Google Scholar 

  54. Somirathne D, Goonewardene M, Dasanayake L. Three doses of oral misoprostol versus an intra-cervical Foley catheter for 24 hours for pre-induction cervical ripening in post- dated pregnancies: a randomized controlled trial. Ceylon Med J. 2017;62(2):77. https://doi.org/10.4038/cmj.v62i2.8470.

    CAS  Article  PubMed  Google Scholar 

  55. Leigh S, Granby P, Haycox A, Mundle S, Bracken H, Khedikar V, Mulik J, Faragher B, Easterling T, Turner MA, et al. Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost-consequence analysis alongside a clinical trial. BJOG. 2018;125(13):1734–42.

    CAS  PubMed  PubMed Central  Article  Google Scholar 

  56. Abdi N, Alavi A, Pakbaz F, Darabi H. Vaginal misoprostol versus intracervical Foley catheter for cervical ripening in postdate primigravid women: a randomized clinical trial. BMC Pregnancy Childbirth. 2021;21(1):533. https://doi.org/10.1186/s12884-021-04011-0.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  57. Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021;34(7):1034–41. https://doi.org/10.1080/14767058.2019.1623776.

    Article  PubMed  Google Scholar 

  58. Jozwiak M, Mol BW, Bloemenkamp KW. Dutch consortium of studies in Obstetrics G, Fertility: Induction of labour in nulliparous women with an unfavourable cervix. BJOG. 2010;117(7):892; author reply 892-893.

    Article  Google Scholar 

  59. Sherman DJ, Frenkel E, Tovbin J, Arieli S, Caspi E, Bukovsky I. Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experience and review. Obstet Gynecol Surv. 1996;51(10):621–7.

    CAS  PubMed  Article  Google Scholar 

  60. Lajusticia H, Martinez-Dominguez SJ, Perez-Roncero GR, Chedraui P, Perez-Lopez FR, Health O, Systematic Analyses P. Single versus double-balloon catheters for the induction of labor of singleton pregnancies: a meta-analysis of randomized and quasi-randomized controlled trials. Arch Gynecol Obstet. 2018;297(5):1089–100.

    PubMed  Article  Google Scholar 

  61. de Los Reyes SX, Sheffield JS, Eke AC. Single versus Double-Balloon Transcervical Catheter for Labor Induction: A Systematic Review and Meta-Analysis. Am J Perinatol. 2019;36(8):790–7.

    PubMed  Article  Google Scholar 

  62. Liu YR, Pu CX, Wang XY, Wang XY. Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis. Arch Gynecol Obstet. 2019;299(1):7–12.

    CAS  PubMed  Article  Google Scholar 

  63. Liu X, Wang Y, Zhang F, Zhong X, Ou R, Luo X, Qi H. Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis. BMC Pregnancy Childbirth. 2019;19(1):358.

    PubMed  PubMed Central  Article  Google Scholar 

  64. Chen W, Xue J, Peprah MK, Wen SW, Walker M, Gao Y, Tang Y. A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. BJOG. 2016;123(3):346–54.

    CAS  PubMed  Article  Google Scholar 

  65. de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019;10:CD001233.

    PubMed  Google Scholar 

  66. Sanchez-Ramos L, Kaunitz AM, Wears RL, Delke I, Gaudier FL. Misoprostol for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 1997;89(4):633–42.

    CAS  PubMed  Article  Google Scholar 

  67. Bracken H, Mundle S, Faragher B, Easterling T, Haycox A, Turner M, Alfirevic Z, Winikoff B, Weeks A. Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol. BMC Pregnancy Childbirth. 2014;14:308.

    PubMed  PubMed Central  Article  Google Scholar 

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Authors

Contributions

GZ: manuscript writing, data collection, data analysis; GS: data collection, data analysis; JL: project development, manuscript writing. All authors have read and approved the manuscript.

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Correspondence to Jing Liu.

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The study was approved by the Institutional Review Board (IRB) of the First Affiliated Hospital of China Medical University (NO. 2022035 on February 25, 2022). The IRB waived the need for informed consent because this was a meta-analysis study based on published data.

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Supplementary Information

Additional file 1:

 TableS1. PRISMA Network Meta-analysis Checklist. TableS2. Strategy of this meta-analysis. TableS3. Head-to-head comparisons of cesarean delivery rate. Table S4. Head-to-head comparisons oftime from intervention-to-birth. TableS5. Head-to-head comparisons of achieving vaginal delivery within 24 hours.Table S6. Head-to-head comparisonsof Bishop score increment. Table S7. Head-to-head comparisons of uterine hyperstimulation with fetal heart ratechanges. Table S8. Head-to-headcomparisons of oxytocin augmentation. TableS9. Head-to-head comparisons of instrumental delivery. Table S10. Head-to-head comparisons of meconium-stained amnioticfluid. Table S11. Head-to-headcomparisons of chorioamnionitis. TableS12. Head-to-head comparisons of postpartum hemorrhage. Table S13. Head-to-head comparisons ofApgar score <7 in 5 min. Table S14.Head-to-head comparisons of Apgar score <7 in 1 min. Figure S15. Inconsistency test of Apgar score <7 in 1 min. Table S16. Head-to-head comparisons ofarterial pH. Table S17. Assessmentof publication bias for network meta-analysis. Figure S1. Risk of bias summary. Figure S2. Risk of bias graph. FigureS2. Risk of bias graph. Figure S4. Inconsistency test of cesarean delivery rate. Figure S5. Inconsistency test of Time from intervention-to-birth. Figure S6. Inconsistency test ofachieving vaginal delivery within 24 hours. Figure S7. Inconsistency test of Bishop score increment. Figure S8. Inconsistency test ofuterine hyperstimulation with fetal heart rate changes. Figure S9. Inconsistency test of oxytocin augmentation. Figure S10. Inconsistency test ofinstrumental delivery. Figure S11. Inconsistency test of meconium-stained amniotic fluid. Figure S12. Inconsistency test of chorioamnionitis. Figure S13. Inconsistency test ofpostpartum hemorrhage. Figure S14. Inconsistency test of Apgar score <7 in 5 min. Figure S15. Inconsistency test of Apgar score <7 in 1 min. Figure S16. Inconsistency test ofneonatal intensive care unit admission. Figure S17. Funnel plot of primary outcomes. Figure S18. Funnel plot of secondary outcomes.

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Zhao, G., Song, G. & Liu, J. Safety and efficacy of double-balloon catheter for cervical ripening: a Bayesian network meta-analysis of randomized controlled trials. BMC Pregnancy Childbirth 22, 688 (2022). https://doi.org/10.1186/s12884-022-04988-2

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Keywords

  • Cervical ripening
  • Labor induction
  • Double-balloon catheter
  • Foley
  • Dinoprostone
  • Misoprostol
  • Meta-analysis