The Renaissance of Transcervical Balloon Catheters for Cervical Ripening and Labour Induction (original) (raw)
Related papers
Outpatient Induction of Labor – Are Balloon Catheters an Appropriate Method?
Geburtshilfe und Frauenheilkunde, 2021
As the number of labor inductions in high-income countries has steadily risen, hospital costs and the additional burden on obstetric staff have also increased. Outpatient induction of labor is therefore becoming increasingly important. It has been estimated that 20 – 50% of all pregnant women requiring induction would be eligible for outpatient induction. The use of balloon catheters in patients with an unripe cervix has been shown to be an effective and safe method of cervical priming. Balloon catheters are as effective as the vaginal administration of prostaglandin E2 or oral misoprostol. The advantage of using a balloon catheter is that it avoids uterine hyperstimulation and monitoring is less expensive. This makes balloon catheters a suitable option for outpatient cervical ripening. Admittedly, intravenous administration of oxytocin to induce or augment labor is required in approximately 75% of cases. Balloon catheters are not associated with a higher risk of maternal and neonat...
BJOG: An International Journal of Obstetrics & Gynaecology, 2009
Objective To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices. Design Randomised controlled trial. Population A total of 330 nulliparous women with unfavourable cervices induced at term. Methods Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE 2 gel (2 mg) (113 women). Main outcome measures Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction. Results There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE 2 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE 2 (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE 2 group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE 2 group: median arterial pH double balloon 7.26 (range 7.03-7.40); single balloon 7.26 (7.05-7.44); PGE 2 7.25 (6.91-7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score ‡4: double balloon 55%, single balloon 36%, PGE 2 63%, P < 0.001). Conclusions Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
Obstetrics & Gynecology International Journal
Aim: To compare effectiveness and safety of double balloon catheter and prostaglandins for induction of labor. Methods: an observational ambidirectional cohort study was conducted at a tertiary care university hospital. A total of 666 women with a Bishop score ≤6 requiring labor induction were included. A cohort of 418 patients with double balloon catheter were compared with a retrospective cohort of 248 women induced with prostaglandins, either misoprostol or dinoprostone. Perinatal outcomes were compared between groups, with a p<0.05 considered statistically significant. Results: The cesarean-section rate was 27% in the double balloon group, compared with 27.8% in the prostaglandin group (p=0.352). The mean induction time-to-delivery was longer in the double balloon group as compared to the prostaglandin group (26.6±9.3 hrs vs 19.1±8.6 hrs, p<0.001). Hyperdynamia and umbilical-cord arterial pH<7.1 rates were significantly lower with the mechanical method compared to prost...
International Journal of Advanced Research (IJAR), 2019
Introduction:Induction of labour is an intervention after 28 weeks of gestation, intended to artificially initiate uterine contractions resulting in the progressive effacement and dilatation of the cervix and ending in vaginal delivery. Sometimes because of medical or obstetric complications of pregnancy, cervical ripening and induction of labour is often required. Induction of labour is indicated when the benefits to either the mother or fetus outweigh those of continuing the pregnancy [1]. Aim Of The Study:To compare efficacy and safety of intracervical Foley?s balloon catheter with intracervical prostaglandin E2 gel (dinoprostone) for induction of labour. Objectives:To compare cervical ripening, induction-delivery interval, mode of delivery, maternal complications and fetal outcome by two methods. Materials And Methods:Prospective randomized controlled study. SAMPLE SIZE- Each group 50, determined by statistical analysis. Successful induction considered if the patient entered the active phase of labour/ bishop score 6. Result:In present study, both groups were comparable in age distribution. In both the groups, most of the study subjects were between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley?s catheter group). Mean age in PGE2 gel group was 23.20?3.03 years while Mean age in Intra-Cervical Foley?s Catheter group was 23.92?3.11 years. Mean gestational age in PGE2 gel group was 39.12?1.33 weeks compared to 39.06?1.18 weeks in Intra-Cervical Foley?s Catheter group. At start of induction mean Bishop score was 1.62?1.10 in PGE2 gel group while it was 1.58?1.01 in Intra-Cervical Foley?s Catheter group. Deshmukh V et al also reported similar pre-induction mean Bishop score (1.48?0.67 in Foley?s Catheter group v/s 1.59?0.59 in pgE2 gel group). In our study, post-induction mean Bishop score at 6 hours was 6.56?2.13 in PGE2 gel group while it was 4.70?2.21 in Intra-Cervical Foley?s Catheter group. Mean change in Bishop score between 0 to 6 hours was significantly higher in pgE2 gel group (4.94?1.78) compare to Foley?s catheter group (3.12?1.78). The rate of LSCS in pgE2 gel group was 10% and 32% in Foley?s catheter group respectively. The induction delivery interval showed significantly higher time in intracervical Foley?s catheter groups. The mean induction delivery internal was 13.80?3.83 hrs in Foley?s group and 9.65?2.13 hrs in PGE2 group. In our study, common maternal complication observed were Intrapartum pyrexia (1 case in pgE2 gel group and 8 cases in Foley?s catheter group) and puerperal pyrexia (1 case in pgE2 gel group and 4 cases in Foley?s catheter group). 1 case of hyperstimulation was also seen in pgE2 gel group. Apart from that we have not seen any other complication in mothers. The present study shows that the fetal outcome results were also comparable in both the groups. Conclusion:The results of this trial tended to favor the prostaglandins use over Foley catheter use. The main advantage of the PGE2 gel is that early ripening of cervix, lesser caesarean rate and infection rate as compared to the Foley?s catheter while disadvantage is higher chances of uterine hypertonicity or tachysystole. but Foley?s catheter mimicked the physiology of the labour onset more closely, resulting in a less likelihood of hyperstimulation, fetal heart rate abnormalities and postpartum hemorrhage. Now, there is recent trend of reintroducing the mechanical methods like the Foley catheter, as there is an availability of sterile devices, controlling one of the principal contraindications- infection. Such mechanical methods are advantageous in terms of their reversibility and the reduced expenditure. But Foley?s catheter has been linked with a possibility of infections in some larger studies. Thus, tremendous attention should be drawn towards carrying out aseptic measures while it is being inserted, to avoid maternal and probable neonatal infections.
American Journal of Obstetrics and Gynecology, 2010
We performed a metaanalysis of publications comparing the efficacy and safety of cervical ripening and labor induction by Foley catheter balloon (FCB) vs locally applied prostaglandins (LAPG) in the third trimester of pregnancy. Twenty-seven randomized controlled trials (1966-2008; 3532 participants) were selected from MEDLINE, EMBASE, and CENTRAL searches. There was no significant difference between FCB and LAPG in cesarean delivery rates. LAPG had a significantly increased risk of excessive uterine activity (P ϭ .001). FCB had a significantly higher risk of oxytocin induction/augmentation during labor (P ϭ .0002). Cervical prostaglandin-E2 was less effective (P ϭ .04), and vaginal prostaglandin-E1 bore a significantly higher risk of excessive uterine activity (P Ͻ .0001) and meconium staining (P ϭ .04). We concluded that FCB and LAPG result in similar cesarean delivery rates, that FCB bears a higher risk of oxytocin use for labor induction and/or augmentation, and that LAPG carries a higher risk of contraction abnormalities.
BMC Pregnancy and Childbirth, 2014
Background: Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia, the only cure comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventionsoral misoprostol tablets and transcervical Foley catheterizationare already used by some in low resource settings, but their relative risks and benefits are not known. The trial will compare the risks, benefits, and trade-offs in efficacy, safety, acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension. Methods/Design: A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms. Women will be recruited at two hospitals in Nagpur, India. The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences. The Foley group will undergo induction using a Foley catheter (silicone, size 18 F with 30 ml balloon) which will remain until active labor starts, the Foley catheter falls out, or 12 hours have elapsed. The primary outcome will be the attainment of vaginal delivery within 24 hours. Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment.
Journal of the Turkish-German Gynecological Association
Objective: To compare the effectiveness and safety of oxytocin and a cervical ripening balloon in women with unfavorable cervices for inducing labor. Material and Methods: A total of eighty pregnant women between 37-41 gestational weeks having singleton pregnancies and intact membranes with unfavorable cervices were randomized into two groups, cervical ripening balloon (n=40) and oxytocin infusion (n=40). The primary outcomes were the labor time and the route of delivery. Secondary outcomes were the effect of parity on time of labor, and obstetric and perinatal outcomes. Results: The median time to delivery was 9.45 hours in cervical ripening balloon group and 13.2 hours in the oxytocin group in multiparous women. The differences were statistically significant (p<0.001). The median time until delivery was 11.48 hours in cervical ripening balloon group and 13.46 hours in the oxytocin group; the differences were statistically significant (p<0.001). Cesarean delivery ratios were similar in both groups (p=0.431). Conclusion: The results of the present study are promising for balloon use, especially in multiparous women. It is beneficial to support these data with wide ranging population-based studies.
Archives of Gynecology and Obstetrics, 2018
Purpose To analyze the effect of combined application of intravaginal PGE2 insert and intracervical Foley balloon catheter for induction of labor. Methods Patients with unfavorable cervices who required induction of labor from August 2017 to December 2017 were evaluated for the study. Three hundred and ten participants were randomly assigned to study (n:155) and control group (n:155). Nine patients in study group and seven patients in control group were excluded, because they declined to participate in the study. Totally, 294 women analyzed in this prospective randomized study: Group 1 (control group): labor induction with intravaginal PgE2 vaginal insert alone (n = 148) and Group 2 (study group): intracervical Foley balloon catheter insertion adjunct to the intravaginal PgE2 insert (n = 146). The primary outcome of our study was the period from induction to delivery. The secondary outcome was the period from induction to active phase of labor. Results In the analysis of primiparous pregnants, combination of intracervical Foley balloon catheter and intravaginal PgE2 insertion was shown to be associated with shorter duration from induction to active stage of labor (1000 vs. 585 min, P < 0.001) and also to delivery (1386 vs. 1001 min, P < 0.001). Groups were found to be similar in terms of duration from induction to active stage of labor (670.5 vs. 535.2, P > 0.05) and also to delivery (933.1 vs. 777.9, P > 0.05, Table 2) in subgroup of women with the previous vaginal delivery. Conclusions Combined application of intracervical Foley balloon catheter and intravaginal PgE2 insert may result in a shorter time from labor induction to delivery without rising the risk of cesarean section in primiparous women with an unfavorable cervix.
Journal of the Turkish-German Gynecological Association, 2018
Objective: To compare the effectiveness and safety of oxytocin and a cervical ripening balloon in women with unfavorable cervices for inducing labor. Material and Methods: A total of eighty pregnant women between 37-41 gestational weeks having singleton pregnancies and intact membranes with unfavorable cervices were randomized into two groups, cervical ripening balloon (n=40) and oxytocin infusion (n=40). The primary outcomes were the labor time and the route of delivery. Secondary outcomes were the effect of parity on time of labor, and obstetric and perinatal outcomes. Results: The median time to delivery was 9.45 hours in cervical ripening balloon group and 13.2 hours in the oxytocin group in multiparous women. The differences were statistically significant (p<0.001). The median time until delivery was 11.48 hours in cervical ripening balloon group and 13.46 hours in the oxytocin group; the differences were statistically significant (p<0.001). Cesarean delivery ratios were similar in both groups (p=0.431). Conclusion: The results of the present study are promising for balloon use, especially in multiparous women. It is beneficial to support these data with wide ranging population-based studies.