778: Off-label use of Dinoprostone in women after 3 deliveries or more: efficacy and safety (original) (raw)
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Journal of Clinical Medicine, 2021
Background: Vaginal dinoprostone (PGE2) is currently used as the prostaglandin of choice in many obstetric units. However, few studies have evaluated its safety, especially in women who previously had a cesarean section. Objective: To evaluate the efficacy and safety of PGE2 in pregnant women who are undergoing induction of labor (IOL), and who have had a previous cesarean section. Materials and Methods: A prospective observational study was conducted in La Mancha Centro Hospital in Alcázar de San Juan, Spain, from 1 February 2019 to 30 August 2020. Obstetric and neonatal outcomes, following IOL with PGE2, in 47 pregnant women who wanted a trial of labor after cesarean (TOLAC), and 377 pregnant women without a history of cesarean section, were analyzed. The outcomes were analyzed by bivariate and multivariate analyses using binary and multiple linear regression. Results: A total of 424 women were included in this study. The percentage of cesarean sections in the TOLAC group was 44.7...
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.
Background: Cesarean delivery has become the most common major surgical procedure in many parts of the world. Induction of labor in women with prior cesarean delivery is an alternative to mitigate the rising cesarean rates. Objectives: To compare the VBAC success rate between two vaginal forms of dinoprostone for labor induction in women with prior cesarean section. Material and Methods: A pilot study was conducted at a large Governmental Hospital, Dhahran, Saudi Arabia, including 200 women with prior cesarean section and planned for labor induction. Participants were randomly allocated into two groups. Group A (n = 100) received dinoprostone 1.5 mg vaginal tablet. Group B (n = 100) received 10 mg dinoprostone sustained release vaginal pessary. Primary outcome was vaginal delivery rate. Secondary outcomes included maternal and neonatal outcomes. Results: The dinoprostone vaginal tablet and dinoprostone vaginal pessary had a comparable vaginal delivery rate (67% and 64%, respectively; p = 0.78). The median patient satisfaction with the birth process was superior in the dinoprostone vaginal pessary group (p = 0.04). Maternal and neonatal outcomes were similar in both groups. Conclusion: Both forms of dinoprostone were effective methods for labor induction in women with prior cesarean section. However, the patient satisfaction with the birth process was in favor of the dinoprostone sustained release vaginal pessary.
Archives of Gynecology and Obstetrics, 2020
Purpose This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrelreleasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). Methods We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. Results Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. Conclusion Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.
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...
International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 2017
Background: The aim of induction of labour is to achieve vaginal delivery in advance of the normal timing of parturition and to avoid operative delivery. The objective was to study the incidence of instrumental delivery and cesarean section in nulliparous women with unfavourable bishops score at term.Methods: This study was conducted on 200 patients in nulliparous women with unfavourable bishop score, cephalic presentation and no previous history of abortion.Results: The most frequent cause of induction of labour was postdatism (47.5%) followed by PIH (25.5%) and PROM (13%). 143 (71.5%) women had normal vaginal delivery whereas in 54 women (27%) cesarean section was done. 2 women (1%) had forceps application for delivery and remaining 1 women (0.5%) had ventouse delivery. Out of 200 patients 9 had maternal complication of induction of labour.Conclusions: In present study 71.5% women had normal vaginal delivery, 27% had cesarean section. Mean bishop score at induction was 3.31 which ...
VBAC In Women Undergoing IOL With Dinoprostone Versus Spontaneous Labor
The Internet journal of gynecology and obstetrics, 2015
OBJECTIVE: To compare the rate of vaginal birth in women attempting vaginal birth after caesarean delivery (VBAC) through labour induction with dinoprostone versus a trial of spontaneous labour. METHODS: A 10-year retrospective cohort study in a tertiary care hospital of women with one prior caesarean delivery. Women who attempted VBAC with labour induction with dinoprostone were compared with women undergoing spontaneous labour. Logistic regression analyses were performed to assess the relationship between VBAC success and labour induction taking into account confounding variables. Both maternal and neonatal safety were studied to find a difference between the group with spontaneous labour versus the group labour induction. RESULTS: A total of 1076 women in the cohort attempted VBAC (649 with spontaneous labour and 427 with induced labour). Women who were given a trial of spontaneous labour were more likely to have a successful VBAC (70.3% compared with 48.7%, odds ratio (OR) 2.49,...
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.
Concurrent Dinoprostone and Oxytocin for Labor Induction in Term Premature Rupture of Membranes
Obstetrics & Gynecology, 2009
To estimate the effect of concurrent vaginal dinoprostone and oxytocin infusion against oxytocin infusion for labor induction in premature rupture of membranes (PROM) on vaginal delivery within 12 hours and patient satisfaction. METHODS: Nulliparas with uncomplicated PROM at term, a Bishop score less than or equal to 6, and who required labor induction were recruited for a doubleblind randomized trial. Participants were randomly assigned to 3-mg dinoprostone pessary and oxytocin infusion or placebo and oxytocin infusion. A cardiotocogram was performed before induction and maintained to delivery. Dinoprostone pessary or placebo was placed in the posterior vaginal fornix. Oxytocin intravenous infusion was commenced at 2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min. Oxytocin infusion rate was titrated to achieve four contractions every 10 minutes. Primary outcomes were vaginal delivery within 12 hours and maternal satisfaction with the birth process using a visual analog scale (VAS) from 0 to 10 (higher score, greater satisfaction). RESULTS: One hundred fourteen women were available for analysis. Vaginal delivery rates within 12 hours were 25 of 57 (43.9%) for concurrent treatment compared with 27/57 (47.4%) (relative risk 0.9, 95% confidence interval 0.6-1.4, P)58.؍ for oxytocin only; median VAS was 8 (interquartile range [IQR] 2) compared with 8 (IQR 2), P.83.؍ Uterine hyperstimulation was 14% compared with 5.3%, P;02.؍ overall vaginal delivery rates were 59.6% compared with 64.9%, P;07.؍ and induction to vaginal delivery interval 9.7 hours compared with 9.4 hours P57.؍ for concurrent treatment compared with oxytocin, respectively. There was no significant difference for any other outcome. CONCLUSION: Concurrent vaginal dinoprostone and intravenous oxytocin for labor induction of term PROM did not expedite delivery or improve patient satisfaction.
Role of dinoprostone gel in induction of labour
International journal of reproduction, contraception, obstetrics and gynecology, 2021
Labor is a process through which the fetus moves from the intrauterine to the extrauterine environment. It is a clinical diagnosis defined as the initiation and perpetuation of uterine contractions with the goal of producing progressive cervical effacement and dilatation. Induction of labor is common in obstetric practice. It means deliberate termination of pregnancy beyond 28 weeks by any method which aims at the initiation of labor and vaginal delivery. 1-3 The goal of modern obstetrics is to improve the safety of the mother and the fetus during the antenatal period as well as parturition. 4,5 The lowest incidence of perinatal morbidity and mortality occurs around 39-40 weeks of gestation. Therefore, some have advocated induction of uncomplicated singleton gestations once they reach full-term. METHODS This retrospective clinical trial was carried out in the department of obstetrics and gynecology at V. S. General hospital and Sardar Vallabhbhai Patel institute of medical science and research, Ahmedabad from May 2019 to May 2020. The purpose of this study was to evaluate the safety and efficacy of intracervical PGE2 as an inducing agent in women with an unfavorable cervix, at term (Bishop score ≤6). This study comprised of 110 women who required labor induction. Inclusion criteria: Singleton pregnancy between 36-40 weeks live ABSTRACT Background: Labour induction is one of the most common intervention in obstetric practice. A simple application of PGE2 intracervical gel can ripen the cervix effectively and improve Bishop's score there by helping in successful vaginal delivery. Considering its good performance, the dinoprostone slow-release vaginal insert is the first choice for elective induction of labour in postdate pregnancy and in patients with term pregnancy of premature rupture of membranes. Methods: This was a single year retrospective study conducted in a tertiary care center of western India from May 2019 to May 2020. Results: In group I women who delivered within 24 hours were included, in group II women who required reinstillation were included. The most common indication for induction in both the groups was past dates (accounting for 36.1% in group I and 47.3% in group II). The success rate in group I was 68.1% while in group II was 36.8%. The rate of cesarean delivery in group I was 25.9%, while in Group II, it was 60.1%. Negligible maternal and neonatal complications were seen in both the groups. Conclusions: The study showed that intracervical application of prostaglandin E2 is an effective, safe and acceptable method for induction of labor in women with unfavorable cervix and indications for induction. All these effects were achieved without increasing maternal and neonatal morbidity