scholarly journals C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes—a multicentre randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fidan Israfil-Bayli ◽  
Victoria Hodgetts Morton ◽  
Catherine A. Hewitt ◽  
Andrew K. Ewer ◽  
Jim Gray ◽  
...  
Keyword(s):  
At Risk ◽  
Preterm Birth ◽  
Informed Consent ◽  
High Risk ◽  
Perinatal Mortality ◽  
Controlled Trial ◽  
Core Outcome Set ◽  
Cervical Cerclage ◽  
History Of ◽  
Randomised Controlled

Abstract Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. Discussion Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates. Trial registration ISRCTN 15373349. Registered before recruitment on 03 December 2014 prior to first recruit.

scholarly journals C-STICH: Cerclage Suture Type for an Insufficient Cervix and its Effect on Health Outcomes. A Multicentre Randomised Controlled Trial.

2021 ◽  
Author(s):  
Fidan Israfil-Bayli ◽  
Victoria Ann Hodgetts Morton ◽  
Catherine A Hewitt ◽  
Andrew K Ewer ◽  
Jim Grey ◽  
...  
Keyword(s):  
At Risk ◽  
Preterm Birth ◽  
Informed Consent ◽  
High Risk ◽  
Perinatal Mortality ◽  
Controlled Trial ◽  
Core Outcome Set ◽  
Cervical Cerclage ◽  
History Of ◽  
Randomised Controlled

Abstract Background: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either: a history of three or more previous mid trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women; who have taken part in C-STICH previously, aged less than 18 years old at the time of presentation, requiring a rescue cerclage, who are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life) and secondary outcomes include the core outcome set for preterm birth trials.Discussion: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates.Trial registration: ISRCTN 15373349 registered before recruitment 03/12/2014 prior to first recruit.

scholarly journals Cord Blood Haptoglobin, Cerebral Palsy and Death in Infants of Women at Risk for Preterm Birth: A Secondary Analysis of a Randomised Controlled Trial

2019 ◽  
Vol 9 ◽  
pp. 11-18 ◽  
Author(s):  
Catalin S. Buhimschi ◽  
Kathleen A. Jablonski ◽  
Dwight J. Rouse ◽  
Michael W. Varner ◽  
Uma M. Reddy ◽  
...  
Keyword(s):  
At Risk ◽  
Cerebral Palsy ◽  
Preterm Birth ◽  
Randomised Controlled Trial ◽  
Cord Blood ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Randomised Controlled

scholarly journals Effects of stratified medication review in high-risk patients at admission to hospital: a randomised controlled trial

2020 ◽  
Vol 11 ◽  
pp. 204209862095714
Author(s):  
Dorthe Krogsgaard Bonnerup ◽  
Marianne Lisby ◽  
Eva Aggerholm Sædder ◽  
Birgitte Brock ◽  
Tania Truelshøj ◽  
...  
Keyword(s):  
At Risk ◽  
High Risk ◽  
Medication Errors ◽  
Medication Review ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Prescribing Errors ◽  
Medication Reviews ◽  
Randomised Controlled

Background: Patients at high risk of medication errors will potentially benefit most from medication reviews. An algorithm, MERIS, can identify the patients who are at highest risk of medication errors. The aim of this study was to examine the effects of performing stratified medication reviews on patients who according to MERIS were at highest risk of medication errors. Methods: A randomised controlled trial was performed at the Acute Admissions Unit, Aarhus University Hospital, Denmark. Patients were included at admission to the hospital and were randomised to control or intervention. The intervention consisted of stratified medication review at admission on patients with a high MERIS score. Clinical pharmacists and clinical pharmacologists performed the medication reviews; the clinical pharmacologists performed the reviews on patients with the highest MERIS score. The primary outcome measure was the number of prescribing errors during the hospitalisation. Secondary outcomes included self-experienced quality of life, health-care utilisation and mortality measured at follow-up 90 days after discharge. Results: A total of 375 patients were included, of which medication reviews were performed in 64 patients. The medication reviews addressed 63 prescribing errors in 37 patients and 60 other drug-related problems. No difference in the number of prescribing errors during hospitalisation between the intervention group ( n = 165) and control group ( n = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08–0.14) versus 0.13 per drug (95% CI: 0.09–0.16), respectively. No differences in secondary outcomes were observed. Conclusion: A stratified medication review approach based on the individual patient’s risk of medication errors did not show impact on the chosen outcomes. Plain language summary How does a medication review at admission affect patients who are in high risk of medication errors? Patients are at risk of medication errors at admission to hospital. Medication reviews aim to detect and solve these. Yet, due to limited resources in healthcare, it would be beneficial to detect the patients who are most at risk of medication errors and perform medication reviews on those patients. In this study we investigated whether an algorithm, MERIS, could detect patients who are at highest risk of medication errors; we also studied whether performing medication reviews on patients at highest risk of medication errors would have an effect on, for example, the number of medication errors during hospitalisation, qualify of life and number of readmissions. We included 375 patients in a Danish acute admission unit and they were divided into control group and intervention group. Patients in the intervention group received a medication review at admission if they were considered at high risk of medication errors, assessed with the aid of MERIS. In summary, 64 patients in the intervention group were most at risk of medication errors and therefore received a medication review. We conclude in the study that MERIS was useful in identifying relevant patients for medication reviews. Yet, the medication reviews performed at admission did not impact on the chosen outcomes.

scholarly journals Effects of cognitive therapy on the longitudinal development of psychotic experiences in people at high risk of developing psychosis

2007 ◽  
Vol 191 (S51) ◽  
pp. s82-s87 ◽  
Author(s):  
P. French ◽  
N. Shryane ◽  
R. P. Bentall ◽  
S. W. Lewis ◽  
A. P. Morrison
Keyword(s):  
At Risk ◽  
High Risk ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Psychotic Experiences ◽  
Treatment As Usual ◽  
Psychological Treatments ◽  
Emotional Dysfunction ◽  
Randomised Controlled ◽  
Anxiety Depression

BackgroundThere have been recent advances in the identification of people at high risk of psychosis and psychological treatments have shown promise for preventionAimsTo compare the longitudinal course of psychotic experiences and emotional dysfunction in high-risk participants receiving cognitive therapy with those receiving treatment as usualMethodData from a recent randomised controlled trial of cognitive therapy for people at risk of developing psychosis were utilised to examine three different statistical models that were based on 432 measurements of psychotic experiences and 421 of emotional dysfunction (anxiety–depression) contributed by 57 participants across the 13 measurement occasions (monthly monitoring for a year)ResultsPsychotic experiences and emotional dysfunction were correlated and decreased significantly over the course of the study, with most improvement in the early months. The reduction in positive symptoms, but not emotional dysfunction, was enhanced by allocation to cognitive therapyConclusionsPsychotic experiences and emotional dysfunction appear to interact in people at risk of developing psychosis. There appears to be a specific benefit of cognitive therapy

scholarly journals Cerclage outcomes in singleton pregnancies at risk for preterm birth following assisted reproductive treatments

2021 ◽  
Vol 3 (3) ◽  
pp. 78-82
Author(s):  
Gülnaz Şahin ◽  
Ferruh Acet ◽  
Ege Nazan Tavmergen Goker ◽  
Erol Tavmergen
Keyword(s):  
At Risk ◽  
Preterm Birth ◽  
Gestational Age ◽  
Cervical Insufficiency ◽  
Special Group ◽  
Cervical Cerclage ◽  
Unicornuate Uterus ◽  
Gestational Age At Delivery ◽  
History Of ◽  
Singleton Pregnancies

Objective: We aimed to evaluate the obstetric and neonatal outcomes of singleton pregnancies at risk for preterm birth (PTB) following assisted reproductive treatments and underwent cervical cerclage placement. Material and methods: A total of 42 women with singleton pregnancies following ART who underwent cerclage between 2009-2021 were included in this retrospective study.  Indications of the cerclage procedure, gestational age at cerclage placement and delivery, neonatal birthweight, and requirement for admission to the neonatal unit of newborns were evaluated. Results: Of those cerclage placement performed in women with a history of second-trimester loss (19%), women with suspected cervical insufficiency according to pre-pregnancy evaluation (52.4%), women with the unicornuate uterus (4.8%), women with cervical shortening/or suspicious changes on ultrasonography (11.9%), and women with detection of cervical dilatation/shortening beyond 20 weeks of gestation (11.9%). Of the total group, 7.1% resulted in late miscarriages, while the remaining 92.9% ended with a live birth with mean gestational age at delivery of 37.0±2.5 weeks. Of those live births, 92.3% (36/39) delivered at >34 weeks and %74.4 (29/39) delivered at term. Except one neonatal death due to extremely PTB at 26th weeks, all infants were discharged from the hospital with well condition. Conclusion: ART pregnancies are evaluated as a special group as having a higher PTB risk at baseline. Cerclage may be considered in broader indications for suspected cervical insufficiency in these pregnancies. There is need for further studies on the effectiveness of cerclage in these ART pregnancies with suspected cervical insufficiency based on different criterions used.

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