Cerclage for short cervix in twin pregnancies: Systematic review and meta-analysis of randomized trials using individual patient-level data

OBJECTIVE: To evaluate the efficacy of cerclage for preventing preterm birth in twin pregnancies with a short cervical length. DESIGN: We performed an individual patient data meta-analysis. Searches were performed in electronic databases. SETTING: Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA. POPULATION: Twin pregnancies in mothers with short cervical length. METHODS: We performed an individual patient data meta-analysis of randomized trials of twin pregnancies screened by transvaginal ultrasound in second trimester and where mothers had a short cervical length <25 mm before 24 weeks. Eligible women had to be randomized to cerclage vs. no-cerclage (control). MAIN OUTCOME MEASURES: The primary outcome was preterm birth <34 weeks. RESULTS: Three trials with 49 twin gestations with a short cervical length were identified. All original databases for each included trial were obtained from the primary authors. Risk factors were similar in the cerclage and control groups, except that previous preterm birth was more frequent and gestational age at randomization and delivery were earlier in the cerclage group compared with the control group. Adjusting for previous preterm birth and gestational age at randomization, there were no statistically significant differences in primary (adjusted odds ratio 1.17, 95% confidence interval 0.23-3.79) and secondary outcomes. Rates of very low birthweight and of respiratory distress syndrome were significantly higher in the cerclage group than in the control group. CONCLUSION: Based on these Level 1 data, cerclage cannot currently be recommended for clinical use in twin pregnancies with a maternal short cervical length in the second trimester. Large trials are still necessary

Individual patient data meta-analysis : Cervical stitch (cerclage) for preventing pregnancy loss in women

BACKGROUND: Cervical cerclage is a surgical procedure involving suturing the cervix with a purse type stitch to keep it closed during pregnancy. This procedure has been used widely in the management of pregnancies considered at high risk of preterm delivery. Several observational studies into the efficacy of cervical cerclage have claimed high rates of successful pregnancy outcome in women with a poor obstetric history attributed to cervical incompetence. However, a recent aggregate data Cochrane review found no such conclusive evidence from seven included randomised studies. Current data suggests that cervical cerclage is likely to benefit women considered to be 'at very high risk' of a second trimester miscarriage due to a cervical factor, however identifying such women remains elusive and many women may be treated unnecessarily. Undertaking an individual patient data (IPD) meta-analysis of the studies will allow us to investigate whether treatment is more effective in particular subgroups. Such an analysis will also provide a more powerful analysis of the predictors of preterm delivery and pregnancy loss, including ultrasound measurement of cervical length, and will allow a more complete analysis of 'time to event' outcomes. METHODS/DESIGN: The analysis will include data from randomised trials comparing the intervention of elective cerclage versus no cerclage or bedrest to prevent miscarriage or pre-term labour. A specific list of data will be requested for each trial, including demographic and obstetric history data. The primary outcomes of interest will be neonatal mortality/morbidity. Attention will also be given to secondary outcomes such as time from randomisation to delivery, preterm delivery before 32 weeks and maternal morbidity. An intention to treat analysis will be performed, with attention paid to assessing clinical and statistical heterogeneity. Multilevel models with patients and trials as the two levels will be explored to investigate treatment effect on various outcomes. Patient-level covariates will be incorporated into the models in an attempt to account for statistical heterogeneity as well as to investigate interactions with treatment effect. DISCUSSION: Predictive models generated from our analysis should lead to more effective counselling of women at risk and a more cost effective use of cerclage

Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data

OBJECTIVE: The aim of this systematic review and meta-analysis was to quantify the efficacy of cervical cerclage in preventing preterm birth (PTB) in asymptomatic singleton pregnancies with a short mid-trimester cervical length (CL) on transvaginal sonography (TVS) and without prior spontaneous PTB. METHODS: Electronic databases were searched from inception of each database until February 2017. No language restrictions were applied. All randomized controlled trials (RCTs) of asymptomatic singleton pregnancies without prior spontaneous PTB, found to have short CL < 25 mm on mid-trimester TVS and then randomized to management with either cerclage or no cerclage, were included. Corresponding authors of all the included trials were contacted to obtain access to the data and perform a meta-analysis of individual patient-level data. Data provided by the investigators were merged into a master database constructed specifically for the review. Primary outcome was PTB < 35 weeks. Summary measures were reported as relative risk (RR) with 95% CI. The quality of the evidence was assessed using the GRADE approach. RESULTS: Five RCTs, including 419 asymptomatic singleton gestations with TVS-CL < 25 mm and without prior spontaneous PTB, were analyzed. In women who were randomized to the cerclage group compared with those in the control group, no statistically significant differences were found in PTB < 35 (21.9% vs 27.7%; RR, 0.88 (95% CI 0.63-1.23); I2  = 0%; five studies, 419 participants), < 34, < 32, < 28 and < 24 weeks, gestational age at delivery, preterm prelabor rupture of membranes (PPROM) and neonatal outcomes. In women who received cerclage compared with those who did not, planned subgroup analyses revealed a significantly lower rate of PTB < 35 weeks in women with TVS-CL < 10 mm (39.5% vs 58.0%; RR, 0.68 (95% CI, 0.47-0.98); I2  = 0%; five studies; 126 participants) and in women who received tocolytics (17.5% vs 32.7%; RR, 0.54 (95% CI, 0.31-0.93); I2  = 0%; four studies; 169 participants) or antibiotics (18.3% vs 31.5%; RR, 0.58 (95% CI, 0.33-0.98); I2  = 0%; three studies; 163 participants) as additional therapy to cerclage. The quality of evidence was downgraded two levels because of serious imprecision and indirectness, and therefore was judged as low. CONCLUSIONS: In singleton gestations without prior spontaneous PTB but with TVS-CL < 25 mm in the second trimester, cerclage does not seem to prevent preterm delivery or improve neonatal outcome. However, in these pregnancies, cerclage seems to be efficacious at lower CLs, such as < 10 mm, and when tocolytics or antibiotics are used as additional therapy, requiring further studies in these subgroups. Given the low quality of evidence, further well-designed RCTs are needed to confirm the findings of this study

Risk factors for pre-term birth in Iraq: a case-control study

BACKGROUND: Preterm birth (PTB)is a major clinical problem associated with perinatal mortality and morbidity. The aim of the present study is to identify risk factors associated with PTB in Mosul, Iraq. METHODS: A case-control study was conducted in Mosul, Iraq, from 1(st )September, 2003 to 28(th )February, 2004. RESULTS: A total of 200 cases of PTB and 200 controls of full-term births were screened and enrolled in the study. Forward logistic regression analysis was used in the analysis. Several significant risk associations between PTB and the following risk factors were identified: poor diet (OR = 4.33), heavy manual work (OR = 1.70), caring for domestic animals (OR = 5.06), urinary tract infection (OR = 2.85), anxiety (OR = 2.16), cervical incompetence (OR = 4.74), multiple pregnancies (OR = 7.51), direct trauma to abdomen (OR = 3.76) and abortion (OR = 6.36). CONCLUSION: The main determinants of PTB in Iraq were low socio-economic status and factors associated with it, such as heavy manual work and caring for domestic animals, in addition to urinary tract infections and poor obstetric history

Controversies regarding cervical incompetence, short cervix, and the need for cerclage

Copyright © 2004 Elsevier Inc.Cervical incompetence (CI) is not an all or nothing phenomenon but a continuous variable. CI and preterm labor are not distinct entities but rather part of a spectrum leading to preterm delivery. Cervical length (CL) is an independent variable in the prediction of preterm delivery, to which it is inversely related. Application of a primary transvaginal cervical cerclage appears to be an unnecessary intervention in about 50% of women presenting with a history suggesting cervical incompetence. A better alternative for women with a history of or risk factors for CI is transvaginal ultrasonographic follow-up of CL. To facilitate the comparison of studies of CI, the authors suggest a nomenclature reflecting the different stages of prevention: primary, secondary, and tertiary transvaginal cervical cerclage.http://www.elsevier.com/wps/find/journaldescription.cws_home/623324/description#descriptio

A five century evolution of cervical incompetence as a clinical entity

Copyright © 2005 Bentham Science Publishers LtdSince cervical incompetence was introduced in the English literature in 1678, our understanding and obstetric management of this clinical entity, have changed tremendously over the years. This review shows the historical perspective of the development of cervical incompetence as a distinct clinical entity and an all or nothing phenomenon to cervical incompetence as part of a spectrum leading to preterm delivery, which can express differently in subsequent pregnancies. These changes in our understanding imply consequences for the obstetric management of cervical incompetence. This review focuses on the obstetric management of women considered to be at high risk of preterm delivery due to cervical incompetence, by transvaginal ultrasonographic follow-up of cervical length and transvaginal cervical cerclagehttp://www.bentham.org/cpd/contabs/cpd11-6.htm##link

Cervical incompetence: A reappraisal of an obstetric controversy

Cervical incompetence is not a categoric but rather a continuous variable, meaning that there are various degrees in the competency of the cervix. Furthermore, a certain degree of competency of the cervix can be expressed differently in subsequent pregnancies. Women with risk factors for cervical incompetence in their gynecological/obstetric history should be followed by transvaginal ultrasonography. History alone is not an indication for a prophylactic cerclage. Although transvaginal ultrasonography identifies women at high risk of preterm delivery, it does not discriminate between different underlying pathologies. Short cervical length alone is not an indication for a therapeutic cerclage. Serial transvaginal ultrasonographic measurements of cervical length in women with risk factors can identify those women truly at high risk of preterm delivery. A transvaginal cervical cerclage with bed rest reduces preterm delivery and improves perinatal outcome in women with a short cervical length and risk factors for cervical incompetence.Sietske M. Althuisius, Gustaaf A. Dekker, and Herman P. van Geijnhttp://journals.lww.com/obgynsurvey/Abstract/2002/06000/Cervical_Incompetence__A_Reappraisal_of_an.23.asp

Modern management of preterm labour

Preterm birth is the leading cause of neonatal morbidity and mortality. Cervical insufficiency is not an all or nothing phenomenon but a continuous variable which can lead to preterm deliveries at different gestational ages. The relationship between shortened cervical length and spontaneous preterm birth is consistent in several studies. Shortened cervical length can be diagnosed by transvaginal ultrasonography and treated by transvaginal cervical cerclage (TCC). A nomenclature to the different stages of prevention, as primary, secondary and tertiary was suggested to facilitate comparison of studies. Apart from cervical cerclage, the most widely used tocolytics are betamimetics. Although they have been shown to delay delivery, betamimetics have not been shown to improve perinatal outcome, and they have a high frequency of unpleasant and even fatal and maternal side effects. There is growing interest in calcium channel blockers which appear to be more effective than beta-sympathomimetic drugs and have few side-effects

Cervical incompetence prevention randomized cerclage trial: Emergency cerclage with bed rest versus bed rest alone

© 2003 Mosby, Inc. All rights reserved.Objective: The purpose of this study was to compare preterm delivery rates and neonatal morbidity/mortality rates for women with cervical incompetence with membranes at or beyond a dilated external cervical os that was treated with emergency cerclage, bed rest plus indomethacin, versus just bed rest. Study design: Women with cervical incompetence with membranes at or beyond a dilated external cervical os, before 27 weeks of gestation, were treated with antibiotics and bed rest and randomly assigned for emergency cerclage and indomethacin or bed rest only. Results: Twenty-three women were included; 13 women were allocated randomly to the emergency cerclage and indomethacin group, and 10 women were allocated randomly to the bed rest–only group. Gestational age at time of randomization was 22.2 weeks in the emergency cerclage and indomethacin group and 23.0 weeks in the bed rest–only group. Mean interval from randomization until delivery was 54 days in the emergency cerclage and indomethacin group and 20 days in the bed rest–only group (P=.046). Mean gestational age at delivery was 29.9 weeks in the emergency cerclage and indomethacin group and 25.9 weeks in the bed rest–only group. Preterm delivery before 34 weeks of gestation was significantly lower in the emergency cerclage and indomethacin group, with 7 of 13 deliveries versus all 10 deliveries in the bed rest–only group (P=.02). Conclusions: Emergency cerclage, indomethacin, antibiotics, and bed rest reduce preterm delivery before 34 weeks compared with bed rest and antibiotics alone.Sietske M Althuisius, Gustaaf A Dekker, Pieter Hummel, Herman P van Geij