Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group

Introduction There are several local treatment methods for cervical intraepithelial neoplasia that remove or ablate a cone-shaped part of the uterine cervix. There is evidence to suggest that these increase the risk of preterm birth (PTB) and that this is higher for techniques that remove larger par...

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Main Authors: Orestis Efthimiou, Georgia Salanti, Huseyin Naci, Philip Bennett, Antonios Athanasiou, Areti Angeliki Veroniki, Ilkka Kalliala, Sarah Bowden, Maria Paraskevaidi, Pierre Martin-Hirsch, Evangelos Paraskevaidis, Maria Kyrgiou
Format: Article
Language:English
Published: BMJ Publishing Group 2019-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/10/e028009.full
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author Orestis Efthimiou
Georgia Salanti
Huseyin Naci
Philip Bennett
Antonios Athanasiou
Areti Angeliki Veroniki
Ilkka Kalliala
Sarah Bowden
Maria Paraskevaidi
Pierre Martin-Hirsch
Evangelos Paraskevaidis
Maria Kyrgiou
author_facet Orestis Efthimiou
Georgia Salanti
Huseyin Naci
Philip Bennett
Antonios Athanasiou
Areti Angeliki Veroniki
Ilkka Kalliala
Sarah Bowden
Maria Paraskevaidi
Pierre Martin-Hirsch
Evangelos Paraskevaidis
Maria Kyrgiou
author_sort Orestis Efthimiou
collection DOAJ
description Introduction There are several local treatment methods for cervical intraepithelial neoplasia that remove or ablate a cone-shaped part of the uterine cervix. There is evidence to suggest that these increase the risk of preterm birth (PTB) and that this is higher for techniques that remove larger parts of the cervix, although the data are conflicting. We present a protocol for a systematic review and network meta-analysis (NMA) that will update the evidence and compare all treatments in terms of fertility and pregnancy complications.Methods and analysis We will search electronic databases (CENTRAL, MEDLINE, EMBASE) from inception till October 2019, in order to identify randomised controlled trials (RCTs) and cohort studies comparing the fertility and pregnancy outcomes among different excisional and ablative treatment techniques and/or to untreated controls. The primary outcome will be PTB (<37 weeks). Secondary outcomes will include severe or extreme PTB, prelabour rupture of membranes, low birth weight (<2500 g), neonatal intensive care unit admission, perinatal mortality, total pregnancy rates, first and second trimester miscarriage. We will search for published and unpublished studies in electronic databases, trial registries and we will hand-search references of published papers. We will assess the risk of bias in RCTs and cohort studies using tools developed by the Cochrane collaboration. Two investigators will independently assess the eligibility, abstract the data and assess the risk of bias of the identified studies. For each outcome, we will perform a meta-analysis for each treatment comparison and an NMA once the transitivity assumption holds, using the OR for dichotomous data. We will use CINeMA (Confidence in Network meta-analysis) to assess the quality of the evidence for the primary outcome.Ethics and dissemination Ethical approval is not required. Results will be disseminated to academic beneficiaries, medical practitioners, patients and the public.PROSPERO registration number CRD42018115495
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spelling doaj-art-67f9e39169bf4e4a877332a248b7b8eb2025-08-20T01:55:41ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2018-028009Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE groupOrestis Efthimiou0Georgia Salanti1Huseyin Naci2Philip Bennett3Antonios Athanasiou4Areti Angeliki Veroniki5Ilkka Kalliala6Sarah Bowden7Maria Paraskevaidi8Pierre Martin-Hirsch9Evangelos Paraskevaidis10Maria Kyrgiou11senior lecturer4 Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerlandassociate professor3Rheumatology and Radiology departments at hospitals at Zealand, Jutland and Funen, Copenhagen, Slagelse, Aarhus, Silkeborg, Odense, Hjørring and Graasten, Denmarkclinical research fellow1 Knowledge Translation Program, Li Ka Shing Knowledge Institute, St Michael`s Hospital, Toronto, Ontario, CanadaDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College, London, UK1 Department of Surgery and Cancer, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College London, London, UKDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine, Institute of Reproductive and Developmental Biology, Imperial College, London, UK7 Department of Gynaecologic Oncology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKDepartment of Obstetrics & Gynaecology, University of Ioannina, Ioannina, Greeceprofessor of gynaecological oncology, Institute of Reproductive and Developmental BiologyIntroduction There are several local treatment methods for cervical intraepithelial neoplasia that remove or ablate a cone-shaped part of the uterine cervix. There is evidence to suggest that these increase the risk of preterm birth (PTB) and that this is higher for techniques that remove larger parts of the cervix, although the data are conflicting. We present a protocol for a systematic review and network meta-analysis (NMA) that will update the evidence and compare all treatments in terms of fertility and pregnancy complications.Methods and analysis We will search electronic databases (CENTRAL, MEDLINE, EMBASE) from inception till October 2019, in order to identify randomised controlled trials (RCTs) and cohort studies comparing the fertility and pregnancy outcomes among different excisional and ablative treatment techniques and/or to untreated controls. The primary outcome will be PTB (<37 weeks). Secondary outcomes will include severe or extreme PTB, prelabour rupture of membranes, low birth weight (<2500 g), neonatal intensive care unit admission, perinatal mortality, total pregnancy rates, first and second trimester miscarriage. We will search for published and unpublished studies in electronic databases, trial registries and we will hand-search references of published papers. We will assess the risk of bias in RCTs and cohort studies using tools developed by the Cochrane collaboration. Two investigators will independently assess the eligibility, abstract the data and assess the risk of bias of the identified studies. For each outcome, we will perform a meta-analysis for each treatment comparison and an NMA once the transitivity assumption holds, using the OR for dichotomous data. We will use CINeMA (Confidence in Network meta-analysis) to assess the quality of the evidence for the primary outcome.Ethics and dissemination Ethical approval is not required. Results will be disseminated to academic beneficiaries, medical practitioners, patients and the public.PROSPERO registration number CRD42018115495https://bmjopen.bmj.com/content/9/10/e028009.full
spellingShingle Orestis Efthimiou
Georgia Salanti
Huseyin Naci
Philip Bennett
Antonios Athanasiou
Areti Angeliki Veroniki
Ilkka Kalliala
Sarah Bowden
Maria Paraskevaidi
Pierre Martin-Hirsch
Evangelos Paraskevaidis
Maria Kyrgiou
Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
BMJ Open
title Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
title_full Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
title_fullStr Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
title_full_unstemmed Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
title_short Comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE group
title_sort comparative fertility and pregnancy outcomes after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer protocol for a systematic review and network meta analysis from the circle group
url https://bmjopen.bmj.com/content/9/10/e028009.full
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