Punto de sutura cervical (cerclaje) en combinación con otros tratamientos para prevenir el nacimiento prematuro espontáneo en embarazos únicos
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012871.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 24 septiembre 2020see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Embarazo y parto
- Copyright:
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- Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
George Eleje conceived the review question and protocol, assessed studies for inclusion, extracted data, assessed risk of bias, carried out GRADE assessments, contributed to writing the review and approved the final draft.
Ahizechukwu Eke assessed studies for inclusion, assessed risk of bias, carried out GRADE assessments, contributed to writing the review and approved the final
draft.
Joseph Ikechebelu extracted data, contributed to writing the review and approved the final draft.
Princeston Okam searched for studies, screened studies, contributed to writing the review and approved the final draft.
Ifeanyichukwu Ezebialu assessed studies for inclusion, extracted data, assessed risk of bias, carried out GRADE assessments, contributed to writing the review and approved the final draft.
Chito Ilika searched for studies, screened studies, contributed to writing the review and approved the final draft.
Declarations of interest
George U Eleje: none known.
Joseph I Ikechebelu: none known.
Ahizechukwu C Eke: none known.
Princeston C Okam: none known.
Ifeanyichukwu U Ezebialu: none known.
Chito P Ilika: none known.
Acknowledgements
We would like to thank the previous Managing Editor of the Pregancy and Childbirth Group, Sonja Henderson, for her encouragement and advice that led to the registration of the topic for this protocol. We also thank Frances Kellie, the current Managing Editor of the Pregnancy and Chilbirth Group, for her numerous encouragements and words of advice.
Special thanks to Tamara Kredo, Elizabeth Pienaar, Babalwa Zani, Joy Oliver, Solange Durao, Charles Okwundu and Kholiswa Dube of the South African Cochrane Centre for encouraging us in the writing of protocols for systematic reviews. We are grateful to the Nigerian branch of the South African Cochrane Centre (SACC) and GJ Hofmeyr of the Effective Care Research Unit, East London, for training us in the conduct of protocol writing. We would also like to thank Denise Atherton, the Administrative Assistant of the Cochrane Pregnancy and Childbirth Group for all her support towards the completion of this protocol.
GE acknowledges the Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Nnewi Campus, for providing the enabling environment that allowed him to complete this review.
We would like to thank Emily Miller for answering our queries and providing additional data in relation to Miller 2014.
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
As part of the pre‐publication editorial process, this review has been commented on by four peers (an editor and three referees who are external to the editorial team), a member of our international panel of consumers and our Group's Statistical Adviser. The authors are grateful to the peer reviewers (who wish to remain anonymous) for their time and comments.
Version history
| Published | Title | Stage | Authors | Version |
| 2020 Sep 24 | Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies | Review | George U Eleje, Ahizechukwu C Eke, Joseph I Ikechebelu, Ifeanyichukwu U Ezebialu, Princeston C Okam, Chito P Ilika | |
| 2017 Nov 15 | Cervical cerclage in combination with other treatments for preventing preterm birth in singleton pregnancies | Protocol | George U Eleje, Joseph I Ikechebelu, Ahizechukwu C Eke, Princeston C Okam, Ifeanyichukwu U Ezebialu, Chito P Ilika | |
Differences between protocol and review
The differences between our published protocol (Eleje 2017a) and the full review are outlined below.
In our protocol, we stated that we would exclude studies published in abstract form only. No abstracts were identified or excluded in this version of the review. However, in future updates, we will classify potentially eligible studies presented only as abstract as ’Studies awaiting classification’ pending their full publication.
Review title: we have edited the review title from ‘cervical cerclage’ to ‘cervical stitch (cerclage)’ to clarify the intervention for the reader.
Methods/types of outcomes: our protocol included three outcomes listed separately as ‘not prespecified outcomes’. The outcomes were:
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Any intravenous, oral or combined tocolysis – now listed as ‘tocolysis (intravenous, oral or combined)'
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Preterm premature rupture of the membranes – now listed as 'preterm premature rupture of membranes'
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Chorioamnionitis ‐ now incorporated into the edited secondary outcome, ‘maternal infection, including chorioamnionitis, requiring intervention, e.g. antibiotics or delivery’
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Albuterol [therapeutic use];
- Analgesics, Opioid [therapeutic use];
- Anti-Bacterial Agents [therapeutic use];
- Bias;
- Cefazolin [therapeutic use];
- Cerclage, Cervical [*methods];
- Clindamycin [therapeutic use];
- Indomethacin [therapeutic use];
- Opium [therapeutic use];
- Premature Birth [epidemiology, *prevention & control];
- Randomized Controlled Trials as Topic;
- Stillbirth [epidemiology];
- Tocolytic Agents [therapeutic use];
Medical Subject Headings Check Words
Female; Humans; Pregnancy;
PICO
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 1: Serious neonatal morbidity
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 2: Perinatal loss: all ‐ including miscarriages and stillbirth (but no data for neonatal death)
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 3: Stillbirth (intrauterine fetal death at 24 weeks or more)
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 4: Miscarriages (perinatal loss before 24 weeks)
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 5: Preterm birth < 28 weeks
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 6: Preterm birth < 34 weeks
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 7: Preterm birth < 37 weeks
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 8: Serious intracranial pathology
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 9: Serious respiratory morbidity
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 10: Necrotising enterocolitis
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 11: Retinopathy of prematurity
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 12: Maternal infection, including chorioamnionitis, requiring intervention (chorioamnionitis)
Comparison 1: Cervical cerclage in combination with antibiotic and tocolytic versus cervical cerclage alone, Outcome 13: Preterm premature rupture of membranes
| Cervical cerclage in combination with antibiotics and tocolytics versus cervical cerclage alone for preventing preterm birth in singleton pregnancies | ||||||
| Participants: pregnant women with singleton pregnancies in the second trimester of pregnancy and with risk factors for cervical insufficiency undergoing cervical cerclage in addition to other treatments Settings: hospital in Chicago, USA Comparison: cervical cerclage alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with cervical cerclage alone | Risk with cervical cerclage in combination with antibiotics and tocolytics | |||||
| Serious neonatal morbidity (Reported in Miller 2014 as 'composite adverse outcome', which included the following neonatal morbidities: respiratory distress syndrome, necrotising enterocolitis, intraventricular haemorrhage, retinopathy of prematurity, patent ductus arteriosus, sepsis) | Study population | RR 0.62 | 50 | ⊕⊝⊝⊝ | ||
| 500 per 1,000 | 310 per 1,000 | |||||
| Perinatal loss: all ‐ including miscarriages and stillbirth (Note: data not available for neonatal death) | Study population | RR 0.46 | 50 | ⊕⊝⊝⊝ | ||
| 250 per 1,000 | 115 per 1,000 | |||||
| Baby discharged home healthy | See comment | Miller 2014 only reported the number of babies who survived until discharge, not the number of babies discharged home healthy which was the outcome of interest in this review. Survival until discharge reported narratively in this review. | ||||
| Neonatal death before discharge | See comment | This outcome was not reported by Miller 2014 and these data were not available from the trial authors. Miller 2014 did report 'survival until discharge' (reported narratively in this review). | ||||
| Stillbirth: intrauterine death at 24 or more weeks | Study population | Not estimable | 50 | ⊕⊝⊝⊝ | We sought this data from Miller 2014 who confirmed there were no stillbirths (50 infants). | |
| 0 per 1,000 | 0 per 1,000 | |||||
| Preterm birth < 34 completed weeks of pregnancy | Study population | RR 0.78 | 50 | ⊕⊝⊝⊝ | Data obtained from trialist Miller 2014. | |
| 542 per 1,000 | 423 per 1,000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded (‐1) for serious concerns around limitations in study design (risk of bias ‐ there was no blinding of participants and personnel (risk of performance bias)) | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Serious neonatal morbidity Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.62 [0.31, 1.24] |
| 1.2 Perinatal loss: all ‐ including miscarriages and stillbirth (but no data for neonatal death) Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.13, 1.64] |
| 1.3 Stillbirth (intrauterine fetal death at 24 weeks or more) Show forest plot | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.4 Miscarriages (perinatal loss before 24 weeks) Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.13, 1.64] |
| 1.5 Preterm birth < 28 weeks Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.59 [0.27, 1.27] |
| 1.6 Preterm birth < 34 weeks Show forest plot | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.78 [0.44, 1.40] |
| 1.7 Preterm birth < 37 weeks Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.86 [0.54, 1.38] |
| 1.8 Serious intracranial pathology Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | Not estimable |
| 1.9 Serious respiratory morbidity Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.13, 1.64] |
| 1.10 Necrotising enterocolitis Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.46 [0.04, 4.77] |
| 1.11 Retinopathy of prematurity Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.14, 6.05] |
| 1.12 Maternal infection, including chorioamnionitis, requiring intervention (chorioamnionitis) Show forest plot | 1 | 50 | Risk Ratio (M‐H, Random, 95% CI) | 1.38 [0.44, 4.32] |
| 1.13 Preterm premature rupture of membranes Show forest plot | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.08 [1.12, 3.87] |
