Comparative fertility and pregnancy outcomes after local treatment for cervical intra-epithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group
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Published version
Author(s)
Type
Journal Article
Abstract
Introduction: There are several local treatment methods for cervical intra-epithelial 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 and that this is higher for techniques that remove larger parts of the cervix, although the data is conflicting. We present a protocol for a systematic review and network meta-analysis 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 amongst different excisional and ablative treatment techniques and/or to untreated controls. The primary outcome will be preterm birth (PTB; <37weeks). Secondary outcomes will include severe or extreme PTB, prelabour rupture of membranes, low birth weight (<2500gr), neonatal intensive care unit admission, perinatal mortality, total pregnancy rates, 1st and 2nd 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 We will search for published and unpublished studies in electronic databases, trial registries and we will hand-search references of published papers.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 a network meta-analysis once the transitivity assumption holds, using the odds ratio for dichotomous data. We will use CINEMA 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
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 amongst different excisional and ablative treatment techniques and/or to untreated controls. The primary outcome will be preterm birth (PTB; <37weeks). Secondary outcomes will include severe or extreme PTB, prelabour rupture of membranes, low birth weight (<2500gr), neonatal intensive care unit admission, perinatal mortality, total pregnancy rates, 1st and 2nd 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 a network meta-analysis once the transitivity assumption holds, using the odds ratio for dichotomous data. We will use CINEMA 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
Date Issued
2019-10-21
Date Acceptance
2019-09-12
Citation
BMJ Open, 2019, 9
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
9
Copyright Statement
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor
Imperial College Healthcare NHS Trust
Grant Number
RDD09 79560
Subjects
"Ablation Techniques
"Cervical Intraepithelial Neoplasia
"Conization
"Pregnancy
"Premature Birth"[Mesh]
adverse effects"[Mesh]
complications"[Mesh]
surgery"[Mesh]
therapy"[Mesh]
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Article Number
ARTN e028009
Date Publish Online
2019-10-01