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

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

Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): effect of therapeutic cerclage with bed rest vs. bed rest only on cervical length

Objective: To compare the effects of therapeutic cerclage and bed rest vs. just bed rest on cervical length and to relate these effects to the risk of preterm delivery. Design Cervical length was measured in patients at high risk of cervical incompetence. When a cervical length < 25 mm was measured before 27 weeks’ gestation, randomization for therapeutic cerclage and bed rest vs. just bed rest was performed. After randomization, cervical length was measured weekly. For statistical analysis, t-test and Fisher's exact tests were used and P < 0.05 was considered statistically significant. Results Nineteen women were randomly allocated to receive a therapeutic cerclage and bed rest and 16 were allocated to receive bed rest only. Mean cervical lengths and mean gestational ages before randomization were comparable between both groups, overall 19.8 mm and 20.7 weeks. Cervical length was measured again at a mean gestation of 22.1 weeks. Mean cervical length (31 mm) was significantly ( P < 0.0001) longer after cerclage than after bed rest only (19 mm). A cervical length ≥ 25 mm was measured in 22 of the 35 included women, 16 in the cerclage group and six in the bed-rest group ( P = 0.006). Of these 22 women, only one delivered before 34 weeks’ gestation, which was significantly less frequent than six out of 13 women with a cervical length < 25 mm ( P = 0.006). Conclusions: Therapeutic cerclage with bed rest increases cervical length more often than bed rest alone. A postintervention cervical length ≥ 25 mm reduces the risk of preterm delivery in women at high risk of cervical incompetence and a preintervention cervical length < 25 mm