A mathematical model to predict mean time to delivery following cervical ripening with dinoprostone vaginal insert.
ABSTRACT: The main objective of our study was to analyze the mean time to delivery following cervical ripening with a 10 mg dinoprostone vaginal insert. We performed a retrospective observational study at the level III maternity ward of Angers university hospital. We included all women who had cervical ripening with dinoprostone between January 1st, 2015 and September 30th, 2016. Overall, 405 patients were included, and 59.3% (240/405) were nulliparous. The mean time to delivery was 20h39 min ± 10h49 min. 21% of deliveries (86/405) occurred between midnight and 6 h a.m., and the cesarean section rate was 33% (132/405). Multiple regression analysis showed that nulliparity, overweight (BMI ≥ 25), a closed cervix on initial examination and the absence of premature rupture of membranes (PRM) all significantly increased the mean time to delivery. We developed a mathematical model integrating the aforementioned factors and their impact to help predict the mean time to delivery following cervical ripening with dinoprostone vaginal insert: Y = 961.188-80.346 × parity + 21.437 × BMI-165.263 × cervical dilation-241.759 × PRM. This equation allows obstetricians to calculate a personalized time to delivery for each patient, allowing a precise scheduling of dinoprostone insert placement, and thus improving the organization in busy maternity wards.
Project description:BACKGROUND:Successful labor induction depends on the cervical status at the time of induction. Currently, both a Foley catheter and a dinoprostone insert are used for effective cervical ripening. This study compared the efficacy and safety of the intracervical Foley catheter and dinoprostone insert for cervical ripening to achieve successful labor induction. METHODS:PubMed, Embase, and the Cochrane Library were searched from January 2000 to February 2017 for relevant articles. Only published randomized, controlled trials comparing the dinoprostone insert with the Foley catheter were included. RESULTS:Eight trials including 1191 women who received the intracervical Foley catheter balloon and 1199 who received the dinoprostone insert were used for this study. There was no significant difference between the 2 groups regarding the induction-to-delivery (I-D) interval in a random effect model (mean difference, 0.71?hours; 95% confidence interval [CI], -2.50 to 3.91; P?=?.67). The highly significant heterogeneity (I?=?97%) could be explained by the subgroup analysis of the type of Foley catheter and balloon volume. There was no significant difference between the 2 methods regarding the cesarean delivery rate (relative risk, 0.91; 95% CI, 0.78-1.07; P?=?.24), Apgar score, or side effects, including maternal infection rate, postpartum hemorrhage, and hyperstimulation. No obvious publication bias was found. CONCLUSIONS:According to the cesarean delivery rate, the intracervical Foley catheter balloon was as efficient as the dinoprostone insert. A moderate balloon volume (30?mL) and higher dose of dinoprostone (?6?mg) were related to shorter I-D intervals. Additionally, there was no significant difference between the two methods regarding maternal or neonatal safety.
Project description:BACKGROUND:Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24?h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery. METHODS:RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ? 18?years of age at >?37?weeks of gestation who exhibit unfavorable cervical conditions (Bishop score?<?6) 24?h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality. DISCUSSION:This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus. TRIAL REGISTRATION:Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).
Project description:INTRODUCTION:Induction of labour for prolonged pregnancies (PP) when the cervix is unfavourable is a challenging situation. Cervical ripening by pharmacological or mechanical techniques before oxytocin administration is used to increase the likelihood of vaginal delivery. Both techniques are equally effective in achieving vaginal delivery but excessive uterine activity, which induces fetal heart rate (FHR) anomalies, is more frequent after the pharmacological intervention. We hypothesised that mechanical cervical ripening could reduce the caesarean rate for non-reassuring FHR especially in PP where fetuses are already susceptible to this. METHODS AND ANALYSIS:A multicentre, superiority, open-label, parallel-group, randomised controlled trial that aims to compare cervical ripening with a mechanical device (Cervical Ripening Balloon, Cook-Medical Europe, Ireland) inserted in standardised manner for 24?hours to pharmacological cervical ripening (Propess system for slow release system of 10?mg of dinoprostone, Ferring SAS, France) before oxytocin administration. Women (n=1220) will be randomised in a 1:1 ratio in 15 French units. Participants will be women with a singleton pregnancy, a vertex presentation, a term ?41+0?and?42+0?week's gestation, and for whom induction of labour is planned. Women with a Bishop score ?6, a prior caesarean delivery, premature rupture of membranes or with any contraindication for vaginal delivery will be excluded. The primary endpoint is the caesarean rate for non-reassuring FHR. Secondary outcomes are related to delivery and perinatal morbidity. As study investigators and patients cannot be masked to treatment assignment, to compensate for the absence of blinding, an independent endpoint adjudication committee, blinded to group allocation, will determine whether the caesarean for non-reassuring FHR was justified. ETHICS AND DISSEMINATION:Written informed consent will be obtained from all participants. The Tours Research ethics committee has approved this study (2016-R23, 29 November 2016). Study findings will be submitted for publication and presented at relevant conferences. TRIAL REGISTRATION NUMBER:NCT02907060; pre-results.
Project description:Background:The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting. Methods:An 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 outpatient 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. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire. Results:During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. -?21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. Conclusions:A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers. Trial registration:NCT03199820. Registered on June 27, 2017.
Project description: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.
Project description:BACKGROUND:Among the various methods available, the administration of prostaglandins is the most effective for inducing labour in women with an unfavourable cervix. Recent studies have compared treatment with various titrated doses of oral misoprostol with vaginal misoprostol or dinoprostone, indicating that the use of an escalating dose of an oral misoprostol solution is associated with a lower rate of caesarean sections and a better safety profile. The objective of this study is to assess which of these three therapeutic options (oral or vaginal misoprostol or vaginal dinoprostone) achieves the highest rate of vaginal delivery within the first 24?h of drug administration. METHODS:An open-label randomised controlled trial will be conducted in Araba University Hospital (Spain). Women at ?41?weeks of pregnancy requiring elective induction of labour who meet the selection criteria will be randomly allocated to one of three groups: 1) vaginal dinoprostone (delivered via a controlled-release vaginal insert containing 10?mg of dinoprostone, for up to 24?h); 2) vaginal misoprostol (25??g of vaginal misoprostol every 4?h up to a maximum of 24?h); and 3) oral misoprostol (titrated doses of 20 to 60??g of misoprostol following a 3?h on +?1?h off regimen up to a maximum of 24?h). Both intention-to-treat analysis and per-protocol analysis will be performed. DISCUSSION:The proposed study seeks to gather evidence on which of these three therapeutic options achieves the highest rate of vaginal delivery with the best safety profile, to enable obstetricians to use the most effective and safe option for their patients. TRIAL REGISTRATION:NCT02902653 Available at: https://clinicaltrials.gov/show/NCT02902653 (7th September 2016).
Project description:To determine induction start time(s) that would maximise daytime deliveries when using prostaglandin vaginal inserts.Women enrolled into the Phase III trial, EXPEDITE (clinical trial registration: NCT01127581), had labour induced with either a misoprostol or dinoprostone vaginal insert (MVI or DVI). A secondary analysis was conducted to determine the optimal start times for induction by identifying the 12-h period with the highest proportion of deliveries by parity and treatment.Optimal start times for achieving daytime deliveries when using MVI appear to be 19:00 in nulliparae and 23:00 in multiparae. Applying these start times, the median time of onset of active labour would be approximately 08:30 for both parities and the median time of delivery would be the following day at approximately 16:30 for nulliparae and 12:00 (midday) for multiparae. Optimal start times when using DVI appear to be 07:00 for nulliparae and 23:00 for multiparae. Using these start times, the median time of onset of active labour would be the following day at approximately 04:00 and 11:50, and the median time of delivery would be approximately 13:40 and 16:10, respectively.When optimising daytime deliveries, different times to initiate induction of labour may be appropriate depending on parity and the type of retrievable prostaglandin vaginal insert used.
Project description:INTRODUCTION:Labour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC). METHODS AND ANALYSIS:This single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (?5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12?hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12?hours' observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ?6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24?hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population. ETHICS AND DISSEMINATION:Ethical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24?hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses. TRIAL REGISTRATION NUMBER:NCT03471858; Pre-results.
Project description:The safest, most effective and fastest combined approaches to induction of labor is unknown. In an open-label randomized clinical trial we evaluated the efficacy of combination of extra-amniotic Foley's catheter and vaginal misoprostol compared to vaginal misoprostol alone for cervical ripening and induction of labor on the incidence of failed induction, induction-to-delivery interval and adverse maternal and perinatal outcomes.Pregnant women at gestational age of 28 weeks or greater admitted at Kenyatta National Hospital, Kenya for induction of labor were enrolled then randomized to either a combination of extra-amniotic Foley's catheter inflated by 30 cm3 of normal saline and 25 micrograms of vaginal misoprostol or 25 micrograms of vaginal misoprostol alone. Women underwent 6 hourly reviews and additional misoprostol inserted if required. The primary outcome was incidence of failed induction. Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. Induction-to-delivery interval were compared using the log-rank test. P-values of <?0.05 and 95% confidence intervals that excluded the null were considered statistically significant.Between February and May 2016, we enrolled 180 of 237 pregnant women admitted for induction of labor and randomized them to either a combination of extra-amniotic Foley's catheter and vaginal misoprostol (n =?90) or vaginal misoprostol alone (n =?90). The socio-demographic and obstetric characteristics were similar between the two groups. Failed induction rates were lower but not statistically significant following combined extra-amniotic Foley's catheter and vaginal misoprostol (8.9%) versus vaginal misoprostol alone (11.1%). The mean induction-to-delivery time was 4.8 h shorter in the combined extra-amniotic Foley's catheter and vaginal misoprostol (mean 18.9, standard deviation (SD) 7.2 h) compared to misoprostol only group (mean 14.1, SD 6.9 h) (log-rank test, p <?0.001). Maternal and perinatal complications were similar between the two groups.Extra-amniotic Foley's catheter and vaginal misoprostol for cervical ripening and induction of labor did not significantly lower the incidence of failed induction but safely shortened induction-to-delivery time compared to vaginal misoprostol only.Trial was retrospectively registered on 14-03-2016 PACTR201604001535825.
Project description:BACKGROUND:There is increasing interest in carrying out pre-induction cervical ripening on an outpatient basis. However, there are concerns about the use of prostaglandins, the agents commonly used in hospital settings for this indication, because prostaglandins induce uterine contractions that may lead to fetal hypoxia. Indeed, in a recent study we demonstrated abnormalities in 9% of fetal heart rate tracings performed following prostaglandin induced cervical ripening at term. In contrast, we confirmed in the same study that isosorbide mononitrate (IMN) (administered on an inpatient basis) was both effective in inducing cervical ripening at term, and was associated with no associated fetal heart rate abnormalities. METHODS/DESIGN:The aim of this study is to determine whether IMN self administered by women on an outpatient basis improves the process of induction of labour. Specifically, we hypothesise that the use of outpatient IMN will result in a shorter inpatient stay before delivery, decreased costs to the health service and greater maternal satisfaction with ripening and induction of labour, compared with placebo treatment. In the study described here (the "IMOP" study), women scheduled for induction of labour at term, and who require pre-induction cervical ripening will be randomised to self-administer at home either IMN 40 mg, or a placebo, each vaginally, at 48 hours, 32 hours and 16 hours before scheduled hospital admission. After admission to hospital, treatment will revert to the usual induction of labour protocol. We will compare the primary outcomes of the elapsed time interval from hospital admission to vaginal delivery, the costs to the health service of induction of labour, and women's experience of induction of labour in the two groups. DISCUSSION:This trial will provide evidence on the efficacy of outpatient IMN for pre-induction cervical ripening at term. We will study a formulation of IMN which is cheap and widely available. If the treatment is effective, acceptable to women, and cost effective, it could be implemented into obstetric practice worldwide. TRIAL REGISTRATION:The trial has been registered on the International Standard Randomised Controlled Trial Number Register (ISRCTN) and given the registration number ISRTN39772441.