Dataset Information

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

ABSTRACT:

Objective

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.

Design

Multicentre, open label, randomised controlled trial.

Setting

Eight hospitals in the Netherlands, August 2009 to May 2014.

Participants

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 ?g fenoterol (n=414) intravenously for uterine relaxation before ECV.

Main outcome measures

The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis.

Results

Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events.

Conclusions

In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.

Trial registration

Dutch Trial Register, NTR 1877.

SUBMITTER: Velzel J

PROVIDER: S-EPMC5421458 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

Velzel Joost J Vlemmix Floortje F Opmeer Brent C BC Molkenboer Jan F M JF Verhoeven Corine J CJ van Pampus Mariëlle G MG Papatsonis Dimitri N M DN Bais Joke M J JM Vollebregt Karlijn C KC van der Esch Liesbeth L Van der Post Joris A M JA Mol Ben Willem BW Kok Marjolein M

BMJ (Clinical research ed.) 20170126

<h4>Objective</h4> 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.<h4>Design</h4> Multicentre, open label, randomised controlled trial.<h4>Setting</h4> Eight hospitals in the Netherlands, August 2009 to May 2014.<h4>Participants</h4> 830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were rando ...[more]

PMID: 28126898

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Project description:Introduction Fetal breech presentation at terms occurs in 3 - 6% of pregnancies. External cephalic version can reduce the number of cesarean sections and vaginal breech deliveries. Different approaches are used to carry out external cephalic version. This study looked at the different approaches used in Germany and compared the approach used with the recommendations given in German and international guidelines. Material and Methods An anonymized online survey of 234 hospitals in Germany was carried out in 2018. In addition to asking about hospital structures, questions also focused on how external version was carried out in practice (preparations, tocolysis, anesthetics, etc.), on relative and absolute contraindications and on the success rate. Results 37.2% of the hospitals approached for the survey participated in the study. Of these, 98.8% performed external version procedures. The majority of participating hospitals were university hospitals (26.4%) and maximum care hospitals (35.6%) with an average number of more than 2000 births per year (60.9%). External cephalic version is the preferred (61.7%) obstetrical procedure to deal with breech presentation, rather than vaginal breech birth or primary cesarean section. 45.8% of respondents carry out external version procedures on an outpatient basis, and 42.1% of hospitals perform the procedure as an inpatient intervention, especially from the 37th week of gestation. Prior to performing an external version procedure, 21.6% of surveyed institutions carry out a vaginal examination to evaluate possible fixation of the fetal rump. 95.5% of institutions used fenoterol for tocolytic therapy; the majority using it for continuous tocolysis (70.2%). 1 - 3 attempts at external version (8.4%) were usually carried out by a specific senior physician. In most cases, no analgesics were administered. The reported rate of emergency cesarean sections was very low. The most common indication for emergency C-section was pathological CTG (56,7%). The assessment of relative and absolute contraindications varied, depending on the surveyed hospital. 67.5% asked patients to empty their bladders before carrying out external version, while 10.8% carried out external version when the bladder was filled. The reported success rate was more than 45%. After successful version, only 14.8% of hospitals arranged for patients to wear an abdominal binder. For 32.4%, the decision to apply an abdominal binder was taken on a case-by-case basis. Conclusion The approach used in Germany to carry out external cephalic version is based on the (expired) German guideline on breech presentation. Based on the evidence obtained, a number of individual recommendations should be re-evaluated. More recent international guidelines could be useful to update the standard procedure.

Project description:PURPOSE: To determine the maternal and fetal outcomes of successful external cephalic version (ECV) as well as factors predicting vaginal birth. METHODS: The ECV data over a period of three years at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) between 1 September 2008 and 30 September 2010 was reviewed. Sixty-seven patients who had successful ECV were studied and reviewed for maternal, fetal, and labour outcomes. The control group comprised patients with cephalic singletons of matching parity who delivered following the index cases. RESULTS: The mean gestational age at ECV was 263 ± 6.52 days (37.5 weeks ± 6.52 days). Spontaneous labour and transient cardiotocographic (CTG) changes were the commonest early adverse effects following ECV. The reversion rate was 7.46%. The mean gestational age at delivery of the two groups was significantly different (P = 0.000) with 277.9 ± 8.91 days and 269.9 ± 9.68 days in the study group and control groups, respectively. The study group needed significantly more inductions of labour. They required more operative deliveries, had more blood loss at delivery, a higher incidence of meconium-stained liquor, and more cord around the neck. Previous flexed breeches had a threefold increase in caesarean section rate compared to previous extended breeches (44.1% versus 15.2%, P = 0.010). On the contrary, an amniotic fluid index (AFI) of 13 or more is significantly associated with a higher rate of vaginal birth (86.8% versus 48.3%, P = 0.001). CONCLUSIONS: Patients with successful ECV were at higher risk of carrying the pregnancy beyond 40 weeks and needing induction of labour, with a higher rate of caesarean section and higher rates of obstetrics complications. Extended breech and AFI 13 or more were significantly more likely to deliver vaginally postsuccessful ECV. This additional information may be useful to caution a patient with breech that ECV does not bring them to behave exactly like a normal cephalic, so that they have more realistic expectations. However, these predictive factors needed further confirmation and hopefully, in the future, they would be able to further enhance counselling prior to ECV.

Project description:BackgroundWomen who have a breech presentation at term have to decide whether to attempt external cephalic version (ECV) and how they want to give birth if the baby remains breech, either by planned caesarean section (CS) or vaginal breech birth. The aim of this study was to explore the attitudes of women with a breech presentation and health professionals who manage breech presentation to ECV.MethodsWe carried out semi-structured interviews with pregnant women with a breech presentation (n=11) and health professionals who manage breech presentation (n=11) recruited from two hospitals in North East England. We used purposive sampling to include women who chose ECV and women who chose planned CS. We analysed data using thematic analysis, comparing between individuals and seeking out disconfirming cases.ResultsFour main themes emerged from the data collected during interviews with pregnant women with a breech presentation: ECV as a means of enabling natural birth; concerns about ECV; lay and professional accounts of ECV; and breech presentation as a means of choosing planned CS. Some women's attitudes to ECV were affected by their preferences for how to give birth. Other women chose CS because ECV was not acceptable to them. Two main themes emerged from the interview data about health professionals' attitudes towards ECV: directive counselling and attitudes towards lay beliefs about ECV and breech presentation.ConclusionsWomen had a range of attitudes to ECV informed by their preferences for how to give birth; the acceptability of ECV to them; and lay accounts of ECV, which were frequently negative. Most professionals described having a preference for ECV and reported directively counselling women to choose it. Some professionals were dismissive of lay beliefs about ECV. Some key challenges for shared decision making about breech presentation were identified: health professionals counselling women directively about ECV and the differences between evidence-based information about ECV and lay beliefs. To address these challenges a number of approaches will be required.

Dataset Information

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

Objective

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Trial registration

Publications

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

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