孕中期流产和早产是一个重大的全球性问题。手术宫颈环扎术是为了防止妊娠丢失和早产。它利用单丝或编织缝合线。假设编织材料被病原菌定植,导致阴道菌群失调,感染和环扎失败。
该研究的主要目的是检查使用单丝缝合材料而不是编织缝合材料对需要阴道宫颈环扎术的女性妊娠损失的有效性。
■优势开放随机对照试验。
■英国有75个产妇站点。
单胎妊娠需要宫颈环扎术的妇女。
■单丝缝合线或编织缝合线。
■主要结局是妊娠丢失(流产和围产期死亡率,包括生命第一周内的任何死产或新生儿死亡)。次要结果包括早产的核心结果集。
■女性被按1:1的比例随机分配到单丝或编织环扎组,使用定制的随机服务,并根据网站进行最小化。环扎的适应症,打算使用黄体酮和计划的手术技术。纳入标准是三个或更多以前的中期流产或早产,在先前的怀孕中插入环扎术,在当前妊娠或临床医生认为有早产风险的妇女中,有中期流产或早产的病史,宫颈长度缩短。排除标准是急诊或抢救环扎术,年龄<18岁,无法给予知情同意或环扎术必须放在腹部。原始样本量是基于相对风险降低41%,从编织组的19%的妊娠损失率降低到单丝组的11%,功率为90%,α为p=0.05。独立数据监测委员会注意到试验中汇总事件的发生率低于预期,并建议将样本量增加到2050年。使用孕产妇和新生儿医疗记录中的临床记录表收集结果数据,并报告给伯明翰临床试验单位。
■共有2049名女性被随机分组,在提款和后续损失后,纳入了单丝组1005名女性和编织组993名女性的数据.两组之间的基线人口统计学相似。没有证据表明单丝和编织组之间的妊娠损失率存在差异(80/1003vs.75/993;调整风险比:1.05,95%置信区间:0.79~1.40;调整风险差:0.002,95%置信区间:-0.02~0.03)。
■该试验未收集长期儿科结局。没有安全问题。
■没有证据表明单丝缝合线和编织缝合线之间的妊娠损失有差异。
■在C-STICH(宫颈不足的环扎缝合类型及其对健康结果的影响)试验中出生的新生儿的长期随访。
■本试验注册为ISRCTN15373349。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖项编号:13/04/107)资助,并在《卫生技术评估》中全文发布。28号40.有关更多奖项信息,请参阅NIHR资助和奖励网站。
宫颈环扎术是在怀孕期间进行的防止流产和早产的手术。宫颈环扎术有时被推荐用于在之前有早产婴儿或之前有宫颈手术的妇女。环扎手术涉及在子宫(子宫颈)的颈部插入针迹,以在怀孕期间保持其闭合并防止其过早打开。执行操作时,医生可以使用由不同材料制成的不同类型的线。用于执行操作的线称为缝线。一种缝合线类型是单股或单丝线,另一种是多丝编织线,有许多细丝线编织在一起。一些证据表明,使用单丝缝合线通过防止感染来防止妊娠损失。因此,我们进行了一项使用单丝缝合线与编织缝合线的随机对照试验,旨在减少作为常规护理一部分的环扎术妇女的妊娠损失。这些妇女同意参加这项研究,并被随机分配使用单丝或编织缝合线进行环扎术;他们计划的怀孕护理没有其他变化。从他们的医疗记录中记录并分析了他们怀孕期间发生的事情。共有2049名妇女同意参加这项研究,并同意分析她们的怀孕和新生儿结局。宫颈不足的环扎缝合类型及其对健康结局的影响表明,两种缝合线之间的妊娠损失没有差异。在接受单丝缝合的妇女中,母体败血症减少,绒毛膜羊膜炎(这是分娩期间子宫内的感染)减少,这需要进一步调查。尽管更多使用单丝线进行环扎术的女性需要进行小手术和麻醉,通常在36到37周之间,在阴道分娩前移除单丝缝合线,他们的婴儿的结局没有差异。
UNASSIGNED: Second trimester miscarriage and preterm birth is a significant global problem. Surgical cervical cerclage is performed to prevent pregnancy loss and preterm birth. It utilises either a monofilament or braided suture. It is hypothesised that a braided material becomes colonised with pathogenic bacteria that causes vaginal dysbiosis, infection and cerclage failure.
UNASSIGNED: The primary objective of the study was to examine the effectiveness of using a monofilament suture material as opposed to a braided suture material on pregnancy loss in women requiring a vaginal cervical cerclage.
UNASSIGNED: Superiority open randomised controlled trial.
UNASSIGNED: Seventy-five maternity sites across the UK.
UNASSIGNED: Women experiencing a singleton pregnancy requiring a cervical cerclage.
UNASSIGNED: Monofilament suture or braided suture.
UNASSIGNED: The primary outcome was pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life). Secondary outcomes included the core outcome set for preterm birth.
UNASSIGNED: Women were randomised on a 1 : 1 basis to monofilament or braided cerclage utilising a bespoke randomisation service with minimisation dependent on the site, indication for cerclage, intention to use progesterone and planned surgical technique. The inclusion criteria were three or more previous mid-trimester losses or preterm births, insertion of a cerclage in a previous pregnancy, a history of a mid-trimester loss or preterm birth with a shortened cervical length in the current pregnancy or in women who clinicians deemed at risk of preterm birth. The exclusion criteria were an emergency or rescue cerclage, age of < 18 years, being unable to give informed consent or the cerclage having to be placed abdominally. The original sample size was calculated based on a relative risk reduction of 41% from a pregnancy loss rate of 19% in the braided group to 11% in the monofilament group with 90% power and alpha at p = 0.05. The independent data monitoring committee noted a lower-than-anticipated pooled event rate within the trial and recommended an increase in sample size to 2050. The outcome data were collected using clinical record forms from the maternal and neonatal medical records and reported to Birmingham Clinical Trials Unit.
UNASSIGNED: A total of 2049 women were randomised, after withdrawals and loss to follow-up, data on 1005 women in the monofilament group and 993 women in the braided group were included. The baseline demographics between the groups were similar. There was no evidence of a difference in pregnancy loss rates between the monofilament and braided groups (80/1003 vs. 75/993; adjusted risk ratio: 1.05, 95% confidence interval: 0.79 to 1.40; adjusted risk difference: 0.002, 95% confidence interval: -0.02 to 0.03).
UNASSIGNED: The trial did not collect long-term paediatric outcomes. There were no safety concerns.
UNASSIGNED: There was no evidence of a difference in pregnancy loss between a monofilament suture and a braided suture.
UNASSIGNED: Long-term follow-up of neonates born within the C-STICH (cerclage suture type for an insufficient cervix and its effects on health outcomes) trial.
UNASSIGNED: This trial is registered as ISRCTN15373349.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/04/107) and is published in full in Health Technology Assessment; Vol. 28, No. 40. See the NIHR Funding and Awards website for further award information.
Cervical cerclage is an operation performed in pregnancy to prevent miscarriage and preterm birth. A cervical cerclage is sometimes recommended in women who have had babies born prematurely before or who have had previous cervical surgery. A cerclage operation involves a stitch being inserted around the neck of the womb (cervix) to keep it closed during pregnancy and to prevent it opening prematurely. When performing the operation, the doctor can use different types of threads made of different materials. The threads used to perform the operation are called sutures. One suture type is a single strand or monofilament thread, and the other is a multifilament braided thread with lots of thin strands woven together. Some evidence has suggested that using a monofilament suture thread prevented pregnancy loss by preventing infection. Therefore, we performed a randomised controlled trial of the use of monofilament suture thread versus braided suture thread, aiming to reduce pregnancy loss in women who were having a cerclage as part of their routine care. The women consented to take part in the study and were randomly allocated to their cerclage performed with either a monofilament or braided suture thread; there was no other change to their planned pregnancy care. What happened in their pregnancy was recorded from their medical records and analysed. A total of 2049 women agreed to take part in the study and consented to the analysis of their pregnancy and neonatal outcomes. Cerclage suture type for an insufficient cervix and its effects on health outcomes showed that there was no difference in pregnancy loss between the two suture threads. There was decreased maternal sepsis and decreased chorioamnionitis (which is an infection inside the womb during labour) in the women who received a monofilament suture, which needs further investigation. Although more women who had a cerclage using the monofilament thread needed a small operation and an anaesthetic, often between 36 and 37 weeks, to remove the monofilament suture prior to a vaginal birth, there were no differences in the outcomes for their babies.