Dataset Information

CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk.

ABSTRACT:

Background

Full dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown.

Methods

There are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG).

Craft-obs

Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth.

Craft-rct

Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section.

Craft-img

Imaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche.

Discussion

The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.

Trial registration

CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ).

SUBMITTER: Carlisle N

PROVIDER: S-EPMC7667480 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

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Project description:Background:During the last decades, the rate of caesarean section is increasing and this can increase the mortality and morbidity. Up to one third of the caesarean sections are attributed to the elective repeat caesarean section (ERCS). This study aims to evaluate attitudes and factors affecting the choice of pregnant women with one previous caesarean section regarding their mode of delivery in their second pregnancy. By assessing these attitudes, this study can help the efforts in developing strategies to increase the rates of vaginal delivery. Material and methods:A cross-sectional design was conducted by a structured questionnaire on 166 pregnant women who had delivered once by caesarean section for their first pregnancy and were in the third trimester of their second pregnancy. Any women with an absolute indication for caesarean section was excluded. The study comprises women who attend the clinic at our center in Northern of Jordan. Proper statistical tests were performed to assess the association between the choice of delivery and selected demographic and clinical factors. Results:About 55.4% responded that they would choose ERCS (n = 92) and the remaining participants chose trial of labour after caesarean section (TOLAC) (n = 74). Fear of pain was the most common reason for choosing caesarean section, accounting for 55.4%. Interestingly, our study did not show a significant association between the mode of delivery and demographic factors, such as age, educational level and occupation. The single independent significant factor influencing patients' choice that our study revealed was "being informed about the complications of TOLAC". The choice of TOLAC was almost four times higher for those participants who had been informed about the complications, compared to those who had not been informed. Conclusion:Proper counselling is a main factor that affected the patients' choice toward the mode of delivery. Proper pain management may encourage patients to choose TOLAC because fear of pain was a main reason that patients requested ERCS instead of TOLAC.