Foley catheter compared with controlled release dinoprostone vaginal insert for labor induction after one previous cesarean delivery: A randomized trial (original) (raw)
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BACKGROUND Induction of labor (IOL) can be defined as the artificial initiation of labor, before its spontaneous onset, for the purpose of delivery of the fetoplacental unit 1. Need for mandatory induction of preterm labor is increasing with the increasing incidence of hypertensive disorders, diabetes mellitus, oligohydramnios, intra uterine fetal deaths (IUFD), eclampsia, and lethal congenital anomalies. OBJECTIVES 1. To assess the clinical profile of the patient undergoing preterm induction of labor. 2. To determine the efficacy and safety profile of the two common methods of induction,namely intrauterine Foley's catheter alone and intrauterine Foley's catheter along with intracervicalDinoprostal gel METHODS The study was conducted in Gandhi Hospital from November 2017 to April 2019. 100 women who underwent preterm mandatory induction of labor were taken into the study. RESULTS Thepost induction Bishops score, mean time taken for bulb expulsion, induction to delivery interval and rate of failed induction was statistically significant. 1) The post induction Bishops scores were 5.66 and 6.38 respectively in induction with Foleys catheter and Foleys with Dinoprostone gel groups. 2) The mean time for bulb expulsion was 17 and 10.95 hours respectively. 3) The mean time of induction to delivery interval was 24.06 and 17.82 hours respectively. 4) Out of 50 cases in each group 7 cases underwent deflation of Foleys bulb after 24 hours in Foleys group and 4 underwent deflation in Foleys with Dinoprostone gel group. Thus, we conclude that preterm induction of labor by Foleys catheter with Dinoprostone gel was superior to Foleys catheter alone in terms of induction to delivery interval without affecting caesarean section rate, hyperstimulation, chorioamnionitis, endometritis and other complications. CONCLUSION Our study involved comparing the efficacy of Foleys catheter with combined method i.e., Foleys with Dinoprostone gel, showed that combined method was more superior than Foleys alone in terms of induction delivery interval without any complications when prompt delivery is necessitated.
Foley Catheter Compared With the Controlled-Release Dinoprostone Insert
Obstetrics & Gynecology, 2014
To assess efficacy of the Foley catheter compared with the dinoprostone vaginal insert for beginning labor inductions at or near term. METHODS: We performed a multicenter randomized controlled trial. We enrolled women at 36 weeks of gestation or greater with a singleton live fetus in cephalic presentation, intact membranes, an unfavorable cervix (dilation less than 3 cm; if 2 cm, less than 80% effaced), and no contraindication to labor or either study agent. Women were allocated to either a cervical Foley catheter inflated to 30 mL or dinoprostone for up to 12 hours. Oxytocin was allowed only after study agent removal. The primary outcome was time from agent placement to delivery. Secondary outcomes included delivery by 24 hours, vaginal delivery by 24 hours, time to vaginal delivery, cesarean delivery rate, and rate of tachysystole. Analysis was by intent-to-treat. RESULTS: We enrolled 376 patients, 185 allocated to Foley catheter and 191 to dinoprostone. In the Foley catheter group, time to delivery was shorter (median 21.6 compared with 26.6 hours; P5.003), more patients delivered within 24 hours (56% compared with 40%; P5.003), more delivered vaginally within 24 hours (44% compared with 30%; P5.004), and time to vaginal delivery was shorter (median 20.1 compared with 24.3 hours; P5.005). The cesarean delivery rates were 29% compared with 39% (P5.07). Uterine tachysystole occurred in 0% compared with 3% (P5.06). CONCLUSION: Starting labor inductions with a Foley catheter, compared with the dinoprostone vaginal insert, results in a shorter time to delivery and a higher proportion of women delivered and delivered vaginally within 24 hours. Cesarean delivery rates were not statistically significantly different.
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.
INDIAN JOURNAL OF APPLIED RESEARCH, 2021
BACKGROUND: The uterus remains quiescent throughout 9 months and begins to act on its own when full term is approached. Almost 50% women deliver in the duration of one week before and after the calculated EDD; and induction of labour is needed in about 20% of women: to increase the success of labour induction, to reduce the duration and complications of labour and to diminish the rate of caesarean sections. Cervical ripening is needed before induction of labour. There are many methods for induction of labour; however till date, none of them can claimed to be the best. To compare the AIM OF PRESENT STUDY: safety and efcacy of Dinoprostone gel versus intracervical foley's catheter for ripening of cervix and induction of labour. Compara MATERIAL AND METHODS: tive prospective study was conducted on 400 full term uncomplicated primigravida women needing induction of labour between January 2019 to June 2020 in department of obstetrics & gynecology at GMC Kota in Rajasthan.Group A: 20...
Journal of Perinatal Medicine, 2011
Objective: To compare the efficacy and safety of two methods for induction of labor after previous cesarean section. Methods: To compare 247 women with a previous cesarean section who were induced with a dinoprostone vaginal insert and 279 women with a previous cesarean section induced with oxytocin, between 2001 and 2008. We evaluated vaginal delivery rate, maternal morbidity and newborn morbidity and mortality. Results: The overall rate of vaginal delivery was 65.2%. We did not find significant differences between induction with dinoprostone vaginal insert and oxytocin in the rate of cesarean section performed (35.6% vs. 34.1%, Ps0.71). There were nine cases of uterine rupture (rate of 1.7%), of which four occurred with dinoprostone vaginal insert and five when using oxytocin (Ps0.89). We found no significant differences in neonatal outcomes. Conclusions: Both tested methods appear to be equally safe and effective for induction of labor in women with a previous cesarean section.
Medical Archives, 2022
Background: Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. It is usually performed in high-risk pregnancies, but can also be beneficial in low-risk populations, as shown in the ARRIVE trial. Objective: To evaluate the effectiveness and safety of slow-release vaginal dinoprostone (prostaglandin E2 10 mg) for labor induction in women with low-risk pregnancies. Methods: A prospective study was performed at Hanoi Obstetrics and Gynecology Hospital, Vietnam. We recruited women with low-risk pregnancies from 39 weeks + 0 days to 40 weeks + 6 days of gestation and an unfavorable cervix. Women who participated received 10 mg intravaginal slow-release dinoprostone (Propess) for induction of labor. Labor, deliveries, and post-partum management were performed according to the local protocol. Results: From September 2020 to March 2021, 102 low-risk women were eligible to participate in the study. Among these women, 67.6% had vaginal deliveries, 6.9% had postpartum bleeding, and 3.9% experienced tachysystole. All newborns were healthy, with good APGAR scores. None of the women needed respiratory support or intensive care unit admission. All other maternal or fetal complications were explored. The rate of cesarean section was 3.8 higher in nulliparous than multiparous women and 2.2 times higher in women who did not receive epidural analgesia than in those who did. The risk of cesarean section increased if the time between labor induction and active labor was greater than 12.5 hours. Conclusion: Slow-release dinoprostone insert is safe and effective for the induction of labor in low-risk pregnant women. The risk of cesarean section was elevated in nulliparous patients and those who did not receive epidural analgesia during labor. As the time from labor induction to active labor increased, the risk of cesarean section increased.
Effects Foley catheter placement to expedite the process of delivery
International Journal of Research in Medical Sciences, 2015
Stimulate labor is one of the most common and essential actions in obstetric and labor induction has been done in more than 15 percent of pregnancies and now amniotomy and oxytocin induction of labor are common methods. 1-3 The success of these approaches related to the degree of readiness of the cervix (cervical) and in unfavorable cervix with Bishop Score less than 6, the induction is common. 4 For the success of labor induction in inappropriate cervical addition to the preparation medication methods like prostaglandin E 2 , the mechanical methods such as Foley catheter can be used. 5 Prostaglandin E 2 has been better the preparation of the cervix physiologically by increasing the water under cervical mucus and change collagen bands and increase the uterine myometrium sensitivity to oxytocin. 6-7 Foley catheter through the cervix is an effective, low-cost and uncomplicated method which locally stimulates the release of prostaglandins by press at the top of the inner ABSTRACT Background: Finding a suitable procedure in cases requiring termination of pregnancy without having a ready cervix to induction of labor, is a considerable problem in midwifery. The aim of this study was to compare the effect of Foley catheter placement with oxytocin to expedite the process of delivery. Methods: This is an interventional study. In this study, patient information including age, gestational age, residence place, education, induction time, induction complications, cesarean delivery after induction were entered in a checklist. Collected data analyzed by descriptive and analytical statistical methods in SPSS.16. Results: In this study 100 pregnant women were enrolled in two equal size groups, case (receiving a Foley catheter and oxytocin) and control (receiving oxytocin), each with 50 patient. The mean age of cases was 24.7±3.4 years and controls were 23.9±2.3 years and the most prevalent age group in both was 20-30. In cases 14 % and in controls 12 % were with underlying disease and 14% of women in case group and 24% of women in control group had narrowing of vaginal canal. The most common reason for starting induction in cases was lack of progress in labor and in controls dilation of delivery. The mean gestational age in cases was 39.9±1.9 and in control 39.2±1.8 weeks. In relation to dilatation progress, results showed that in cases individuals reached to full dilatation early and this difference was, in cases 14 % and in controls 22% of deliveries are ended to caesarean. 14% of deliveries in cases and 22% in controls are ended to Caesarean section. There was no significant difference between two groups in birth time Apgar score and 5 minutes after birth time. Conclusions: Results showed that, Foley catheter could significantly reduce induction time significantly and resulted to faster labor but did not reduce the rate of caesarean.
BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the out-patient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥16 years, undergoing Induction of labour (IoL) at term, with intact membranes and deemed suitable for out-patient IoL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Health economics data were collected. Women who declined to participate were also requested to complete a decliners’ questionnaire.ResultsDuring the study period 274 eligible women were identified. 230 (83.9%) were approached for participation of whom 84 (36.5%) agreed. Of these, 38 were randomised to Propess (n=20) and CRB (n=18). T...
Acta Obstetricia et Gynecologica Scandinavica, 2010
Objective. To compare 24-hour controlled-release vaginal dinoprostone pessary vs. gel for induction of labor at term in women with an unfavorable cervix. Design. Randomized controlled trial. Setting. University hospital. Population. A total of 133 women with singleton pregnancies, fetal cephalic presentation, Bishop score £ 4, gestational age of 37-42 weeks, no previous cesarean section and intact membranes admitted for induction of labor. Methods. Random allocation to either 24-hour 10-mg controlled-release vaginal dinoprostone pessary or repeat doses of 2 mg vaginal dinoprostone gel. Main outcome measures. Rate of spontaneous vaginal, operative vaginal and cesarean delivery. Results. The rate of spontaneous vaginal delivery was significantly higher in the pessary group (72%) than in the gel group (54%), paralleled by a lower rate of operative vaginal deliveries (3 vs. 15%). The difference in cesarean section rate (25 vs. 31%) did not reach statistical significance. Both methods of induction of labor appeared to be safe, with no cases of 5-minute Apgar scores < 7 or episodes of uterine hyperstimulation in either group. The medication cost was lower in the pessary group, with a median saving of 50.20e compared to the gel group.
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2017
We assessed whether early amniotomy, after ripening with a dinoprostone insert, reduces the duration of labor or increases the rate of delivery within the following 24 ho. A prospective randomized controlled study was conducted of 200 consenting, at term pregnant women at the Zeynep Kamil Maternity and Children's Training and Research Hospital. Each participant received vaginal inserts of 10 mg dinoprostone. The women were assigned randomly one of two groups: early amniotomy (artificial rupture of membranes when cervical dilation was at 3 cm) or standard amniotomy (the membranes were left to rupture spontaneously). The primary outcome measures were the time from induction to delivery, and the proportion of women who delivered within 24 h. The median time interval from induction to delivery (13.72 h compared to 22.73 h) were significantly shorter for women who underwent early amniotomy(p<0.05). The frequency of vaginal delivery within 24 h was higher in women with early amniot...