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Article ; Online: Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS)—an international multi-stakeholder Delphi study

Shawn Walker / Tisha Dasgupta / Andrew Shennan / Jane Sandall / Catey Bunce / Phoebe Roberts

Trials, Vol 23, Iss 1, Pp 1-

study protocol

2022 Volume 8

Abstract: Abstract Background Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not ... ...

Abstract	Abstract Background Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth. Methods The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study’s pre-established Patient and Public Involvement (PPI) group, to enable service user perspectives on the results of the literature review to influence the design of the Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritise outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies. Discussion The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration Core Outcome Measures in Effectiveness Trials (COMET) #1749
Keywords	Consensus ; Core outcome set ; Delphi ; Breech presentation ; Clinical trial ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Understanding challenges as they impact on hospital-level care for pre-eclampsia in rural Ethiopia

Andrew Shennan / Charlotte Hanlon / Jane Sandall / Rosie Mayston / Tanya Robbins / Tigist Eshetu Guangul / Rahel Demissew / Ahmed Abdella

BMJ Open, Vol 13, Iss

a qualitative study

2023 Volume 4

Abstract: Objective To explore hospital-level care for pre-eclampsia in Ethiopia, considering the perspectives of those affected and healthcare providers, in order to understand barriers and facilitators to early detection, care escalation and appropriate ... ...

Abstract	Objective To explore hospital-level care for pre-eclampsia in Ethiopia, considering the perspectives of those affected and healthcare providers, in order to understand barriers and facilitators to early detection, care escalation and appropriate management.Setting A primary and a general hospital in southern Ethiopia.Participants Women with lived experience of pre-eclampsia care in the hospital, families of women deceased due to pre-eclampsia, midwives, doctors, integrated emergency surgical officers and healthcare managers.Results This study identified numerous systemic barriers to provision of quality, person-centred care for pre-eclampsia in hospitals. Individual staff efforts to respond to maternal emergencies were undermined by a lack of consistency in availability of resources and support. The ways in which policies were applied exacerbated inequities in care. Staff improvised as a means of managing with limited material or human resources and knowledge. Social hierarchies and punitive cultures challenged adequacy of communication with women, documentation of care given and supportive environments for quality improvement.Conclusions Quality care for pre-eclampsia requires organisational change to create a safe space for learning and improvement, alongside efforts to offer patient-centred care and ensure providers are equipped with knowledge, resources and support to adhere to evidence-based practice.
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: OptiBreech collaborative care versus standard care for women with a breech-presenting fetus at term

Shawn Walker / Emma Spillane / Kate Stringer / Lauren Trepte / Siân M Davies / Jacana Bresson / Jane Sandall / Andrew Shennan / OptiBreech Collaborative

PLoS ONE, Vol 18, Iss 11, p e

A pilot parallel group randomised trial to evaluate the feasibility of a randomised trial nested within a cohort.

2023 Volume 0294139

Abstract: OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 ... ...

Abstract	OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus > 33 weeks, at four sites in England, January-June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a 'new care process', with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January-June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Recent advances in the diagnosis and management of pre-eclampsia [version 1; referees

Kate Duhig / Brooke Vandermolen / Andrew Shennan

F1000Research, Vol

2 approved]

2018 Volume 7

Abstract: Pre-eclampsia is a leading cause of maternal mortality, responsible annually for over 60,000 maternal deaths around the globe. Pre-eclampsia is a multisystem disease featuring hypertension, proteinuria, and renal, hepatic, and neurological involvement. ... ...

Abstract	Pre-eclampsia is a leading cause of maternal mortality, responsible annually for over 60,000 maternal deaths around the globe. Pre-eclampsia is a multisystem disease featuring hypertension, proteinuria, and renal, hepatic, and neurological involvement. Diagnosis is often elusive, as clinical presentation is highly variable. Even those with severe disease can remain asymptomatic. Angiogenic factors are emerging as having a role in the diagnosis of pre-eclampsia and in prognostication of established disease. In this article, we summarize new developments and focus on angiogenic biomarkers for prediction of disease onset. We also discuss recent advances in management strategies for patients with hypertensive disorders of pregnancy.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2018-02-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Role of PTB Clinics

Gabrielle Vernet / Helena Watson / Alex Ridout / Andrew Shennan

Women’s Health Bulletin, Vol 4, Iss 4, Pp 1-

A Review of the Screening Methods, Interventions and Evidence for Preterm Birth Surveillance Clinics for High-Risk Asymptomatic Women

2017 Volume 9

Abstract: Context: Preterm birth accounts for significant neonatal mortality and morbidity as well as substantial health costs. As our understanding of aetiology and risk factors for preterm birth increases, predictive tools and prophylactic interventions have ... ...

Abstract	Context: Preterm birth accounts for significant neonatal mortality and morbidity as well as substantial health costs. As our understanding of aetiology and risk factors for preterm birth increases, predictive tools and prophylactic interventions have been developed to improve maternal and fetal outcomes. These are effective, but require surveillance of asymptomatic high-risk women, as well as ultrasound and surgical expertise. This has led to the development of preterm birth surveillance clinics (PSCs), which pool these resources together and have changed the focus of care from reactive to predictive and preventative management. Methods: A literature review of the evidence surrounding the predictive tests (cervical length, fetal fibronectin, Actim Partus, Partosure) and prophylactic interventions (cerclage, progesterone, Arabin pessary, antibiotics, and steroids) for preterm birth to understand what preterm birth surveillance clinics do and how effective they are. Results: Measuring cervical length and fetal fibronectin levels are two of the most accurate predictive tests preterm birth, especially when used in combination. Other predictive tools like Actim Partus and Partosure are effective for symptomatic women, but their role in surveillance of asymptomatic women is unclear. Cervical cerclage is effective in reducing preterm birth in women with previous losses, but the role of progesterone and pessaries remains debated. Steroids remain one of the most effective antenatal intervention, but they need to be administered within a tight timeframe in order to confer maximal benefit. The role of PSCs in predicting the timing of birth and targeting women at highest risk to appropriate interventions is therefore crucial in optimizing care and improving outcomes. Conclusions: Nearly every step of management is still debated although many have a strong evidence-base and effective interventions do exist. The challenge is finding the optimal management pathway, and details of which populations benefit from which ...
Keywords	preterm birth ; predictive ; fetal fibronectin ; cervical length ; cervical cerclage ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2017-10-01T00:00:00Z
Publisher	Shiraz University of Medical Sciences
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The feasibility of team care for women seeking to plan a vaginal breech birth (OptiBreech 1)

Shawn Walker / Emma Spillane / Kate Stringer / Amy Meadowcroft / Tisha Dasgupta / Siân M. Davies / Jane Sandall / Andrew Shennan / the OptiBreech Collaborative

Pilot and Feasibility Studies, Vol 9, Iss 1, Pp 1-

an observational implementation feasibility study in preparation for a pilot trial

2023 Volume 16

Abstract: Abstract Background OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of ... ...

Abstract	Abstract Background OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of implementing OptiBreech team care prior to proceeding with a planned pilot randomised controlled trial. Methods Our design was an observational implementation feasibility assessment across England and Wales, January 2021–June 2022. Our objectives were to determine whether Trusts could provide attendants with advanced training (implementation feasibility), who deliver protocol-consistent care (fidelity), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility). Participants included women > 37 weeks pregnant with a breech-presenting foetus, requesting support for a vaginal breech birth following standard counselling, and staff involved in the study. No randomisation occurred in this first stage of feasibility work. Results Thirteen National Health Service sites were recruited. A total of 82 women planned births in the study. Sites with a breech specialist midwife recruited at double the rate of sites without (0.90/month, 95% CI 0.64–1.16 vs 0.40, 95% CI 0.12–0.68). Referrals into the study came from midwives (46%), obstetricians (34%) and women themselves (20%). Vaginal births were attended by staff with OptiBreech training at 87.5% (35/40, 95% CI 0.732–0.958) and by staff who met additional proficiency criteria at 67.5% (27/40, 95% CI 0.509–0.814). Fidelity criteria were more consistently met by staff who also met proficiency criteria. There were four neonatal admissions (4.9%, 4/82), including one serious adverse outcome (1.2%, 1/82). Conclusions A prospective observational cohort of OptiBreech collaborative care, which could potentially support nested or cluster randomisation, appears feasible in sites willing to establish a dedicated clinic and strategically develop further ...
Keywords	Feasibility ; Implementation ; Breech presentation ; Intrapartum care ; Medicine (General) ; R5-920
Subject code	420
Language	English
Publishing date	2023-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Brain volumetry in fetuses that deliver very preterm

Lisa Story / Alice Davidson / Prachi Patkee / Bobbi Fleiss / Vanessa Kyriakopoulou / Kathleen Colford / Srividhya Sankaran / Paul Seed / Alice Jones / Jana Hutter / Andrew Shennan / Mary Rutherford

NeuroImage: Clinical, Vol 30, Iss , Pp 102650- (2021)

An MRI pilot study

2021

Abstract: Background: Infants born preterm are at increased risk of neurological complications resulting in significant morbidity and mortality. The exact mechanism and the impact of antenatal factors has not been fully elucidated, although antenatal infection/ ... ...

Abstract	Background: Infants born preterm are at increased risk of neurological complications resulting in significant morbidity and mortality. The exact mechanism and the impact of antenatal factors has not been fully elucidated, although antenatal infection/inflammation has been implicated in both the aetiology of preterm birth and subsequent neurological sequelae. It is therefore hypothesized that processes driving preterm birth are affecting brain development in utero. This study aims to compare MRI derived regional brain volumes in fetuses that deliver < 32 weeks with fetuses that subsequently deliver at term. Methods: Women at high risk of preterm birth, with gestation 19.4–32 weeks were recruited prospectively. A control group was obtained from existing study datasets. Fetal MRI was performed on a 1.5 T or 3 T MRI scanner: T2-weighted images were obtained of the fetal brain. 3D brain volumetric datsets were produced using slice to volume reconstruction and regional segmentations were produced using multi-atlas approaches for supratentorial brain tissue, lateral ventricles, cerebellum cerebral cortex and extra-cerebrospinal fluid (eCSF). Statistical comparison of control and high-risk for preterm delivery fetuses was performed by creating normal ranges for each parameter from the control datasets and then calculating gestation adjusted z scores. Groups were compared using t-tests. Results: Fetal image datasets from 24 pregnancies with delivery < 32 weeks and 87 control pregnancies that delivered > 37 weeks were included. Median gestation at MRI of the preterm group was 26.8 weeks (range 19.4–31.4) and control group 26.2 weeks (range 21.7–31.9). No difference was found in supra-tentorial brain volume, ventricular volume or cerebellar volume but the eCSF and cerebral cortex volumes were smaller in fetuses that delivered preterm (p < 0.001 in both cases). Conclusion: Fetuses that deliver preterm have a reduction in cortical and eCSF volumes. This is a novel finding and needs further investigation. If ...
Keywords	Preterm birth ; fetal MRI ; Infection ; Brain volume ; Cortex ; Cerebrospinal fluid ; Computer applications to medicine. Medical informatics ; R858-859.7 ; Neurology. Diseases of the nervous system ; RC346-429
Subject code	610
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Planned delivery to improve postpartum cardiac function in women with preterm pre-eclampsia

Fergus P McCarthy / Jamie O’Driscoll / Paul Seed / Anna Brockbank / Alice Cox / Carolyn Gill / Marcus Green / Mike Marber / Lucilla Poston / Anna Placzek / Andrew Shennan / Jenie Sparkes / Paul Leeson / Basky Thilaganathan / Lucy C Chappell

Efficacy and Mechanism Evaluation, Vol 8, Iss

the PHOEBE mechanisms of action study within the PHOENIX RCT

2021 Volume 12

Abstract: Background: Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-eclampsia, are at increased risk of long-term cardiovascular morbidity and mortality. Objectives: To investigate the hypothesis that ... ...

Abstract	Background: Women whose pregnancies are affected by hypertensive disorders of pregnancy, in particular preterm pre-eclampsia, are at increased risk of long-term cardiovascular morbidity and mortality. Objectives: To investigate the hypothesis that prolongation of a pregnancy affected by preterm pre-eclampsia managed by expectant management compared with planned early delivery would result in worse cardiovascular function 6 months postpartum. Design: A randomised controlled trial. Setting: 28 maternity hospitals in England and Wales. Participants: Women who were eligible for the Pre-eclampsia in HOspital: Early iNductIon or eXpectant management (PHOENIX) study were approached and recruited for the PHOEBE study. The PHOENIX (Pre-eclampsia in HOspital: Early iNductIon or eXpectant management) study was a parallel-group, non-masked, multicentre, randomised controlled trial that was carried out in 46 maternity units across England and Wales. This study compared planned early delivery with expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia who were 34 weeks’ gestation to less than 37 weeks’ gestation and having a singleton or dichorionic diamniotic twin pregnancy. Interventions: Postpartum follow-up included medical history, blood pressure assessment and echocardiography. All women had blood sampling performed on at least two time points from recruitment to the 6-month follow-up for assessment of cardiac necrosis markers. Main outcome measures: Primary outcome was a composite of systolic and/or diastolic dysfunction (originally by 2009 guidelines then updated by 2016 guidelines, with an amended definition of diastolic dysfunction). Analyses were by intention to treat, together with a per-protocol analysis for the primary and secondary outcomes. Results: Between 27 April 2016 and 30 November 2018, 623 women were found to be eligible, of whom 420 (67%) were recruited across 28 maternity units in England and Wales. A total of 133 women were allocated to planned ...
Keywords	preterm pre-eclampsia ; cardiac ; heart ; dysfunction ; echocardiography ; chronic hypertension ; postpartum ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	NIHR Journals Library
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: C-STICH

Fidan Israfil-Bayli / Victoria Hodgetts Morton / Catherine A. Hewitt / Andrew K. Ewer / Jim Gray / Jane Norman / Christoph Lees / Nigel A. B. Simpson / Andrew Shennan / Konstantinos Tryposkiadis / Max Hughes / Jane Daniels / Peter Brocklehurst / Katie Morris / Lee Middleton / Philip Toozs-Hobson

Trials, Vol 22, Iss 1, Pp 1-

Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes—a multicentre randomised controlled trial

2021 Volume 14

Abstract: Abstract Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the ... ...

Abstract	Abstract Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. ...
Keywords	Obstetrics and gynaecology ; Preterm birth ; Cervical cerclage ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2)

Jane E Norman / John Norrie / Graeme MacLennan / David Cooper / Sonia Whyte / Sue Chowdhry / Sarah Cunningham-Burley / Xue W Mei / Joel B E Smith / Andrew Shennan / Stephen C Robson / Steven Thornton / Mark D Kilby / Neil Marlow / Sarah J Stock / Phillip R Bennett / Jane Denton / STOPPIT-2 collaborative group

PLoS Medicine, Vol 18, Iss 3, p e

An open-label randomised trial and updated meta-analysis.

2021 Volume 1003506

Abstract: Background Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in ...

Abstract	Background Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. Methods and findings We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. Conclusions These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. Trial registration ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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