Atosiban versus placebo for threatened preterm birth (APOSTEL 8): a multicentre, randomised controlled trial. Tocolytics are recommended in international guidelines as treatment for threatened preterm birth. Atosiban, an oxytocin receptor antagonist, is a registered tocolytic drug specifically indicated for the treatment of threatened preterm birth. Although tocolytics have been shown to delay birth, benefits on neonatal outcomes have not been demonstrated. In the APOSTEL 8 trial we aimed to assess superiority of tocolysis with atosiban compared with placebo in threatened preterm birth from 30 weeks and 0 days (30 weeks) to 33 weeks of gestation in improving neonatal morbidity and mortality. This was an international, multicentre, randomised, double-blind, superiority trial conducted in 26
Atosiban in individuals with previous implantation failure undergoing frozen blastocyst transfer: a randomized controlled trial. Does the intravenous administration of Atosiban around the time of frozen blastocyst transfer to reduce uterine contractility increase the likelihood of live birth in individuals undergoing ART treatment? In individuals with a history of one previous implantation failure, Atosiban did not significantly increase the live birth rates following frozen blastocyst transfer. Excessive uterine contraction waves during the embryo transfer procedure have been associated with decreased pregnancy rates. Atosiban, an oxytocin receptor antagonist, could reduce uterine contractions and potentially enhance implantation success in ART. However, data are inconclusive. This study
A randomized double blind comparison of atosiban in patients with recurrent implantation failure undergoing IVF treatment. Patients with recurrent implantation failure (RIF) may have more uterine contractions. Several observational studies suggested that atosiban administration around embryo transfer resulted in higher pregnancy rates in RIF patients. This study aimed to evaluate the effect of atosiban given before fresh embryo transfer on pregnancy outcomes of women with RIF. A prospective, randomized, double-blind controlled clinical trial was performed in IVF center of Shanghai First Maternity and Infant Hospital. According to a computer-generated randomization list, 194 infertile women with RIF received fresh embryo transfer between July 2017 and December 2019 were randomly allocated
Atosiban versus ritodrine as tocolytics in external cephalic version. To assess the efficacy of atosiban versus ritodrine as tocolytics in external cephalic version (ECV). A prospective comparative trial was carried out in a tertiary hospital. 430 women with singleton breech pregnancies ≥36 weeks were recruited for ECV, 215 with ritodrine and 215 with atosiban as tocolytic agents. The efficacy , complications and perinatal outcomes were compared between both groups. The associations between variables were analyzed using the chi-square test (χ) (qualitative), Student's test (quantitative, parametric) or Mann-Whitney test (nonparametric). Statistical significance was established as < .05. The overall ECV success rate was 47.9% (206/430), 46.0% in the atosiban group (99/215) and 49.8% in the ritodrine
Randomized Trials of Retosiban Versus Placebo or Atosiban in Spontaneous Preterm Labor. The aim of this study is to assess the efficacy and safety of retosiban in spontaneous preterm labor (sPTL). Two multicenter, randomized, and double-blind trials compared retosiban with placebo and retosiban with atosiban in women with a singleton pregnancy and intact membranes in sPTL at 24 to 33 weeks ' gestation. Coprimary endpoints in the placebo-controlled trial were time to delivery (TTD) or treatment failure (whichever occurred first) and neonatal composite morbidity and mortality. The primary endpoint of the atosiban comparator trial was TTD. The trials were terminated early because of slow recruitment. The placebo-controlled trial enrolled 23 participants (February 2016-July 2017; 2.6% of target
Effects of atosiban on uterine peristalsis following frozen embryo transfer: A randomized controlled trial. To compare the effects of atosiban (oxytocin antagonist) on uterine peristalsis and pregnancy outcomes in the frozen embryo transfer (FET) cycle. Srinagarind Hospital, a university hospital, Khon Kaen, Thailand. A randomized, double-blinded, controlled trial. Fifty infertile women were randomized into the atosiban (n = 25) and placebo group (n = 25). Women in the study group received intravenous atosiban 6.75 mg, 30 min before embryo transfer, and continued infusion at 18 mg/h for 1 h. The dose was reduced to 6 mg/h for another 2 h. Saline solution was applied in the placebo group. The uterine peristalsis frequency was measured by transvaginal ultrasound 30 min before and 3 h after
Atosiban Combined with Ritodrine for Late Threatened Abortion or Threatened Premature Labor Patients with No Response to Ritodrine: A Clinical Trial. BACKGROUND Premature labor is an important cause of infant death and long-term disability. This study aimed to explore the safety and effectiveness of combining the tocolytic agents atosiban and ritodrine to extend gestation. MATERIAL AND METHODS The study included 52 patients with late threatened abortion and threatened premature labor between 20⁰⸍⁷ and 33⁶⸍⁷ weeks' gestation who were administrated continuous tocolytic agents for 48 h. Patients were divided into a research group receiving ritodrine combined with atosiban, owing to having no response to ritodrine alone (n=30), and a control group receiving ritodrine alone (n=22). The mean infusion
Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years. The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group. Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems and general health. The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years. Of the 426 women eligible for follow-up, 196 (46
Effectiveness and safety of atosiban versus conventional treatment in the management of preterm labor. To compare the efficacy of atosiban with conventional treatment of the threatened preterm labor. All the data of pregnant women with threatened preterm labor from January 1 to December 31, 2017, who received atosiban were collected. Pregnant women with conventional treatment (including β -agonists, indomethacin, magnesium sulphate and calcium channel blockers, alone or in combination) were used as control. The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33) (P < 0.0001). For therapy efficacy
The Effect of Atosiban on Patients With Difficult Embryo Transfers Undergoing In Vitro Fertilization-Embryo Transfer. The purpose of this study was to evaluate the effect of atosiban on the outcomes of infertile women undergoing in vitro fertilization (IVF) with difficult embryo transfers (ETs). This randomized double-blind study enrolled 204 infertile women with difficult ETs during IVF treatment between June 2014 and June 2018. According to a computer-generated randomization list, participants were randomized into placebo (n = 102) and atosiban (n = 102) groups. In atosiban group, atosiban with a total dose of 37.5 mg was administered. All of the patients underwent IVF-ET using cryopreserved embryos. The clinical pregnancy rate per cycle and implantation rate per transfer (45.1
Cost effectiveness of nifedipine compared to atosiban in the treatment of threatened preterm birth (APOSTEL III trial). To assess the cost-effectiveness of treatment with nifedipine compared with atosiban in women with threatened preterm birth. An economic analysis alongside a randomised clinical trial (the APOSTEL III study). Obstetric departments of 12 tertiary hospitals and seven secondary hospitals in the Netherlands and Belgium. Women with threatened preterm birth between 25 and 34 weeks of gestation, randomised for tocolysis with either nifedipine or atosiban. We performed an economic analysis from a societal perspective. We estimated costs from randomisation until discharge. Analyses for singleton and multiple pregnancies were performed separately. The robustness of our findings
Bryophyllum pinnatum enhances the inhibitory effect of atosiban and nifedipine on human myometrial contractility: an in vitro study. The herbal medicine Bryophyllum pinnatum has been used as a tocolytic agent in anthroposophic medicine and, recently, in conventional settings alone or as an add-on medication with tocolytic agents such as atosiban or nifedipine. We wanted to compare the inhibitory effect of atosiban and nifedipine on human myometrial contractility in vitro in the absence and in the presence of B. pinnatum press juice (BPJ). Myometrium biopsies were collected during elective Caesarean sections. Myometrial strips were placed under tension into an organ bath and allowed to contract spontaneously. Test substances alone and at concentrations known to moderately affect contractility
Coadministration of the prostaglandin F2α receptor antagonist preterm labour drug candidate OBE022 with magnesium sulfate, atosiban, nifedipine and betamethasone. To investigate presence or absence of clinically relevant drug interactions (pharmacokinetic and safety/tolerability) of OBE022 with standard-of-care medicines for preterm labour, enabling coadministration and further clinical development. Part A: open-label, randomized, 3-period crossover assessing coadministration of single doses of OBE022 (1100 mg) and MgSO . Part B: open-label, single-sequence crossover assessing the interactions following administration of OBE022 (1000 mg/day) at steady state coadministered with single doses of atosiban, nifedipine and betamethasone. Twenty-five healthy nonpregnant women of reproductive age
A Prospective Case-control Trial to Evaluate and Compare the Efficacy and Safety of Atosiban versus Placebo in Recent developments in assisted reproductive technology focus on potential advances to improve its success rate. Atosiban, a combined oxytocin/vasopressin V1a receptor antagonist, is a novel class of drug involved in basic priming of the uterus for successful implantation during embryo transfer (ET). The objective of this study is to evaluate the efficacy of atosiban (study group) in ET patients in comparison to placebo (control group) regarding implantation rate (IR), clinical pregnancy rate (CPR), and ongoing pregnancy rate and to assess the safety profile of atosiban. A total of 320 women undergoing fertilization-ET at a tertiary care hospital were enrolled in the study
Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial. To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. Multicentre, open label, randomised controlled trial. Eight hospitals in the Netherlands, August 2009 to May 2014. 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV. The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation
The effects of nifedipine and atosiban on perinatal brain injury: a secondary analysis of the APOSTEL III trial. Brain injury in neonates born prematurely is associated strongly with poor neurodevelopmental outcome. The aim of this study was to evaluate whether tocolysis with nifedipine or atosiban in women with threatened preterm birth can reduce the incidence of overall brain injury in neonates born prematurely. This was a secondary analysis of the APOSTEL-III trial (Dutch Clinical Trial Registry, no. NTR2947), a randomized clinical trial in which women with threatened preterm labor between 25 and 34 weeks of gestation were allocated to treatment with nifedipine or atosiban. In this secondary analysis, women delivered at ≤ 32 weeks of gestational age in the two main contributing
Differential Effects of Oxytocin Receptor Antagonists, Atosiban and Nolasiban, on Oxytocin Receptor–Mediated Signaling in Human Amnion and Myometrium One of the most established roles of oxytocin (OT) is in inducing uterine contractions and labor. Apart from inducing contractions, our recent studies showed that OT can also activate proinflammatory pathways in both human myometrial and amnion cells, which suggests that the proinflammatory role of OT should be taken into account when developing tocolytics targeting the OT/oxytocin receptor (OTR) system. The OTR antagonist, atosiban, is currently used therapeutically for the treatment of preterm labor. We previously showed that atosiban fails to inhibit the proinflammatory effects of OT in human amnion; atosiban alone activates nuclear
Evaluation of the efficacy of atosiban in pregnant women with threatened preterm labor associated with assisted reproductive technology. The present study aimed to investigate the effectiveness of atosiban in treating women with threatened preterm labor who had become pregnant through assisted reproductive technology (ART) and the corresponding pregnancy outcomes. Seventy pregnant women with threatened preterm labor after ART were randomly divided into two groups, with 35 cases in the atosiban group and 35 in the ritodrine group. The post-treatment effects and the corresponding pregnancy outcomes were observed. The efficacy of extending gestational age by 48 hours was significantly higher in the atosiban group than in the ritodrine group (p<0.05), whereas the efficacy of extending gestational
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB) After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.