Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy - PubMed (original) (raw)

Review

Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy

Timothy J Rafael et al. Cochrane Database Syst Rev. 2014.

Abstract

Background: Cervical cerclage is a surgical intervention involving placing a stitch around the uterine cervix. The suture material aims to prevent cervical shortening and opening, thereby reducing the risk of preterm birth. The effectiveness and safety of this procedure in multiple gestations remains controversial.

Objectives: To assess whether the use of a cervical cerclage in multiple gestations, either at high risk of pregnancy loss based on just the multiple gestation (history-indicated cerclage), the ultrasound findings of 'short cervix' (ultrasound-indicated cerclage), or the physical exam changes in the cervix (physical exam-indicated cerclage), improves obstetrical and perinatal outcomes. The primary outcomes assessed were perinatal deaths, serious neonatal morbidity, and perinatal deaths and serious neonatal morbidity.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2014) and reference lists of retrieved studies.

Selection criteria: All randomised controlled trials (RCTs) of cervical cerclage in multiple pregnancies. Quasi-RCTs and RCTs using a cluster-randomised design were eligible for inclusion (but none were identified). Studies using a cross-over design and those presented only as abstracts were not eligible for inclusion.We included studies comparing cervical cerclage with no cervical cerclage in multiple pregnancies.Studies comparing cervical stitch versus any other preventative therapy (e.g. progesterone) in multiple pregnancies, and studies involving comparisons between different cerclage protocols (history-indicated versus ultrasound-indicated versus physical exam-indicated cerclage) were also eligible for inclusion but none were identified.

Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias. Two review authors extracted data. Data were checked for accuracy.

Main results: We included five trials, which in total randomised 1577 women, encompassing both singleton and multiple gestations. After excluding singletons, the final analysis included 128 women, of which 122 women had twin gestations, and six women had triplet gestations. Two trials (n = 73 women) assessed history-indicated cerclage, while three trials (n = 55 women) assessed ultrasound-indicated cerclage. The five trials were judged to be of average to above average quality, with three of the trials at unclear risk regarding selection and detection biases.Concerning the primary outcomes, when outcomes for cerclage were pooled together for all indications and compared with no cerclage, there was no statistically significant differences in perinatal deaths (19.2% versus 9.5%; risk ratio (RR) 1.74, 95% confidence intervals (CI) 0.92 to 3.28, five trials, n = 262), serious neonatal morbidity (15.8% versus 13.6%; average RR 0.96, 95% CI 0.13 to 7.10, three trials, n = 116), or composite perinatal death and neonatal morbidity (40.4% versus 20.3%; average RR 1.54, 95% CI 0.58 to 4.11, three trials, n = 116).Among the secondary outcomes, there were no significant differences between the cerclage and the no cerclage groups. To name a few, there were no significant differences among the following: preterm birth less than 34 weeks (average RR 1.16, 95% CI 0.44 to 3.06, four trials, n = 83), preterm birth less than 35 weeks (average RR 1.11, 95% CI 0.58 to 2.14, four trials, n = 83), low birthweight less than 2500 g (average RR 1.10, 95% CI 0.82 to 1.48, four trials, n = 172), very low birthweight less than 1500 g (average RR 1.42, 95% CI 0.52 to 3.85, four trials, n = 172), and respiratory distress syndrome (average RR 1.70, 95% CI 0.15 to 18.77, three trials, n = 116). There were also no significant differences between the cerclage and no cerclage groups when examining caesarean section (elective and emergency) (RR 1.24, 95% CI 0.65 to 2.35, three trials, n = 77) and maternal side-effects (RR 3.92, 95% CI 0.17 to 88.67, one trial, n = 28).Examining the differences between prespecified subgroups, ultrasound-indicated cerclage was associated with an increased risk of low birthweight (average RR 1.39, 95% CI 1.06 to 1.83, Tau² = 0.01, I² = 15%, three trials, n = 98), very low birthweight (average RR 3.31, 95% CI 1.58 to 6.91, Tau² = 0, I² = 0%, three trials, n = 98), and respiratory distress syndrome (average RR 5.07, 95% CI 1.75 to 14.70, Tau² = 0, I² = 0%, three trials, n = 98). However, given the low number of trials, as well as substantial heterogeneity and subgroup differences, these data must be interpreted cautiously.No trials reported on long-term infant neurodevelopmental outcomes. There were no physical exam-indicated cerclages available for comparison among the studies included.

Authors' conclusions: This review is based on limited data from five small studies of average to above average quality. For multiple gestations, there is no evidence that cerclage is an effective intervention for preventing preterm births and reducing perinatal deaths or neonatal morbidity.

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Conflict of interest statement

While the above authors contributed to the review as stated above, given that VB is the author of one of the included studies, ZA and TR alone were responsible for assessing studies for inclusion, performing data extraction, data entry and analysis, and assessing risk of biases. All three authors contributed to writing the review. No conflict of interest that might be perceived by others as being capable of influencing their judgements, including personal, political, academic and other possible conflicts, as well as financial conflict exist. There are no additional sources of support.

Figures

1

1

Study flow diagram.

2

2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

3

3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

1.1

1.1. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 1 Perinatal deaths.

1.2

1.2. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 2 Serious neonatal morbidity (defined by trialists).

1.3

1.3. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 3 Composite – Perinatal deaths and serious neonatal morbidity.

1.4

1.4. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 4 Stillbirth (fetal demise after 20 weeks’ gestation, prior to delivery).

1.5

1.5. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 5 Neonatal death (after birth, and before 29 days of neonatal life or discharge from hospital).

1.6

1.6. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 6 Preterm birth less than 28 weeks.

1.7

1.7. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 7 Preterm birth less than 32 weeks.

1.8

1.8. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 8 Preterm birth less than 34 weeks.

1.9

1.9. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 9 Preterm birth less than 35 weeks.

1.10

1.10. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 10 Preterm birth less than 37 weeks.

1.11

1.11. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 11 Mean gestational age at delivery.

1.12

1.12. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 12 Low birthweight defined as less than 2500 grams.

1.13

1.13. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 13 Very low birthweight defined as less than 1500 grams.

1.14

1.14. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 14 Respiratory distress syndrome (defined by trialists).

1.15

1.15. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 15 Intraventricular hemorrhage (defined by trialists).

1.16

1.16. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 16 Necrotising enterocolitis (defined by trialists).

1.17

1.17. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 17 Sepsis (defined by trialists).

1.18

1.18. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 18 Neonatal intensive care unit admission.

1.20

1.20. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 20 Caesarean section (elective and emergency).

1.21

1.21. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 21 Maternal infection requiring intervention, e.g. antibiotics or delivery (including chorioamnionitis and endometritis).

1.22

1.22. Analysis

Comparison 1 Cerclage versus no cerclage, Outcome 22 Maternal side‐effects (vaginal discharge, bleeding, pyrexia not requiring antibiotics).

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References

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