Dataset Information

Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event.

ABSTRACT: OBJECTIVE:To assess adverse event (AE) resolution, delivery mode and neonatal outcomes after misoprostol or dinoprostone vaginal insert (MVI or DVI) retrieval due to AE during induction of labour (IOL). DESIGN:Randomised, double-blind trial, EXPEDITE. SETTING:Thirty five obstetric departments, USA. POPULATION:Consisted of 1358 pregnant women with modified Bishop score ?4 eligible for pharmacological IOL. METHODS:Post hoc analysis. MAIN OUTCOME MEASURES:AEs prompting insert retrieval, times to AE resolution, delivery, delivery mode and neonatal intensive care unit (NICU) admissions. RESULTS:77/678 (11.4%) and 27/680 (4.0%) women had MVI and DVI retrieved due to AE, respectively (P < 0.001). The most common AEs prompting retrieval were uterine tachysystole with fetal heart rate (FHR) involvement and category II/III FHR pattern. Time to AE resolution varied for both treatments depending on the type of AE. For uterine tachysystole with FHR involvement, median resolution times were 1 hour 34.5 minutes (n = 36) and 8.5 minutes (n = 8) for MVI and DVI, respectively. Caesarean delivery occurred in a high proportion of women with insert retrieved due to AE (MVI: 44/77 (57.1%); DVI: 19/27 (70.4%)); the majority of caesareans were performed at least several hours after insert retrieval. Median times from retrieval to any delivery were not increased for women with insert retrieved due to AE. NICU admissions were 8/77 (10.4%) and 1/27 (3.7%) for MVI and DVI, respectively (P = 0.440). CONCLUSIONS:AEs leading to insert retrieval were primarily uterine tachysystole with FHR involvement and category II/III FHR patterns. Insert retrieval due to an AE did not prolong time to delivery for either prostaglandin insert. TWEETABLE ABSTRACT:Induction with prostaglandin vaginal inserts: outcomes following retrieval due to intrapartum adverse event.

SUBMITTER: Rugarn O

PROVIDER: S-EPMC5396314 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event.

Rugarn O O Tipping D D Powers B B Wing D A DA

BJOG : an international journal of obstetrics and gynaecology 20160616 5

<h4>Objective</h4>To assess adverse event (AE) resolution, delivery mode and neonatal outcomes after misoprostol or dinoprostone vaginal insert (MVI or DVI) retrieval due to AE during induction of labour (IOL).<h4>Design</h4>Randomised, double-blind trial, EXPEDITE.<h4>Setting</h4>Thirty five obstetric departments, USA.<h4>Population</h4>Consisted of 1358 pregnant women with modified Bishop score ≤4 eligible for pharmacological IOL.<h4>Methods</h4>Post hoc analysis.<h4>Main outcome measures</h4> ...[more]

PMID: 27307397

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Project description:BackgroundProstaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses on prostaglandins given per vaginam, evaluating these in comparison with placebo (or expectant management) and with each other; prostaglandins (PGE2 and PGF2a); different formulations (gels, tablets, pessaries) and doses.ObjectivesTo determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol).Search methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2014) and bibliographies of relevant papers.Selection criteriaClinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment, with each other, or other methods listed above it on a predefined list of labour induction methods.Data collection and analysisWe assessed studies and extracted data independently.Main resultsSeventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains.Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain.PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance.Authors' conclusionsProstaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important.

Project description:BACKGROUND:A newly developed multiple use applicator for vaginal tablets/vaginal inserts* was evaluated for its general suitability. There are no standard procedures described in guidelines or general accepted publications as to how this kind of product should be tested for suitability of purpose. METHODS:Due to the lack of existing standard procedures, three separate tests were designed and successful executed: (a) First, a patient acceptability evaluation was carried out as part of a phase III trial (registered in EudraCT on 9 Jan 2017, number 2017-000142-22 2. https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number%3A2017-000142-22 ). (b) Secondly, a cleaning procedure for the applicator after simulated multiple use was developed and verified in order to prove a minimized risk of microbiological contamination of the device. A newly developed vaginal fluid to simulate multiple applications was applied for this trial. (c) Lastly, a third trial evaluated the mechanical stability and proper functionality of the applicator after multiple simulated uses. Even potential abrasion of material of the device was checked. RESULTS:Acceptable patient compliance of the new multiple use applicator was verified after 2 weeks of daily use. Furthermore, diary data assessments of patients participating in the Pharmacodynamic part of the trial were evaluated as well. Overall, patient acceptability of the new applicator was proven. The easy-to-use cleaning procedure for the applicator, which can even be carried out in a domestic environment, was developed and successfully verified for effectiveness, meeting all microbiological acceptance criteria for vaginal products of the European Pharmacopeia. The mechanical stability and proper functionality of the applicator after 50 simulated uses was also evaluated. All tested applicator batches (fresh and aged) passed the final evaluation, with no limitations in functionality. CONCLUSION:The tests developed and executed consider various compliance aspects of the newly developed applicator. Results of these individual tests met the expectations and/or the predefined acceptance criteria. All included trials performed produced results justifying and qualifying the applicator for the intended multiple-use. The procedures outlined may also be a guide as to how this kind of medical device can be tested for suitability. Trial registration Registered in EudraCT, number 2017-000142-22, start date 24 May 2017.

Project description:BackgroundWith the development of China's two-child-policy, vaginal birth after cesarean section (VBAC) has aroused public concern. It is important to understand the labour characteristics and intrapartum management of women attempting VBAC to enhance the rates of successful VBAC. The purpose of our research was to investigate the differences in the characteristics of labor, intervention measures and perinatal outcomes between women who had a VBAC and primiparas or multiparas not undergoing VBAC, providing clinical references of intrapartum management for women who are planning a VBAC.Material and methodsThis observational retrospective study enrolled all women who laboured spontaneously and who had a VBAC (n = 139) at the Second Affiliated Hospital of Wenzhou Medical University in China between 2016 and 2019. They were allocated into VBAC group A (the previous cesarean section was performed before dilation of the cervix) and VBAC group B (the previous cesarean section was performed after dilation of the cervix). The primipara control group included 149 primiparae, and the multipara control group included 155 multiparae with second vaginal birth. Durations of labor, intervention measures and perinatal outcomes were compared among the groups.ResultsThe durations of labor, intrapartum interventions and maternal and neonatal outcomes in VBAC group A were similar to those of the VBAC group B. However, all women who had a VBAC and those in VBAC group A had shorter first, second and the total stages of labor than primiparae. All women with VBAC and those in VBAC group B had longer second stage of labor, but shorter third stage of labor than multiparae. Oxytocin, labor analgesia and artificial rupture of membranes were administered less often in women with VBAC than in primiparae, while phloroglucinol was administered more often in women with VBAC than in multiparae. Women who had a VBAC were more likely to receive episiotomy and had higher incidences of postpartum hemorrhage than primipara and multipara women.ConclusionsLabor characteristics, intrapartum interventions and perinatal outcomes in women who had a VBAC with cervical dilation were similar to those in women who had a VBAC without cervical dilation before the previous cesarean section, but differed significantly from those of multiparae and primiparae who did not undergo VBAC.

Dataset Information

Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event.

Publications

Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event.

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