Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial.

Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded. Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians. Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks. Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32). Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT02901626.

Conservative Management of Huge Symptomatic Endocervical Polyp in Pregnancy: A Case Report.

Cervical polyp is very rare in pregnancy, usually asymptomatic and small. There are several reports of different sizes of cervical polyp in pregnancy but, huge cervical polyp causing funnelling and shortening of cervical length was first reported in 2014. It was managed by polypectomy causing cervical length to return to normal value. We present the second case report in literature of a huge endocervical polyp in pregnancy that caused funnelling and shortening of cervical length. Unlike the earlier report this patient presented with preterm contractions and antepartum haemorrhage (APH). She was managed conservatively by polypectomy at 38 weeks of gestation without complications. This is the first case report in the literature of a huge symptomatic endocervical polyp in pregnancy presenting with preterm contractions and APH that was conservatively managed. The role of such management has been emphasized.

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

BACKGROUND: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/DESIGN: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. TRIAL REGISTRATION: Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Fetal fibronectin testing in patients with short cervix in the midtrimester: can it identify optimal candidates for ultrasound-indicated cerclage?

OBJECTIVE: The objective of the study was to determine the relationship between fetal fibronectin (fFN) testing prior to ultrasound-indicated cerclage and obstetric outcome. STUDY DESIGN: Singleton pregnancies between 18 and 24 weeks' gestation with an ultrasound-diagnosed short cervix (< 25 mm) and funneling (> 25%) of the chorioamniotic membranes into the endocervical canal were analyzed. The fFN testing was performed and patients were randomized to cerclage or no-cerclage. Groups were stratified by fFN result. Cerclage patients were compared with no-cerclage patients. The primary outcome was delivery prior to 35 weeks' gestation. RESULTS: Spontaneous preterm birth prior to 35 weeks' gestation occurred in 15 (44.1%) fFN-positive-cerclage patients and 16 (55.2%) fFN-positive no-cerclage patients (P = .45). Similarly, it occurred in 16 (17.8%) fFN-negative cerclage patients and 11 (17%) fFN-no-cerclage patients (P = .99). CONCLUSION: fFN did not identify optimal candidates for cerclage. However, fFN testing before an ultrasound-indicated cerclage aids in counseling patients, anticipating the outcome of pregnancies complicated by cervical shortening.

Clinical management of the short cervix.

Cervical cerclage is associated with prolongation of gestation in singleton pregnancies with prior spontaneous preterm delivery and a short cervix on vaginal ultrasonography in the mid-trimester. Ultrasound screening of cervical length is not indicated in low-risk singleton pregnancies and in women with multiple gestations. 17α-Hydroxyprogesterone does not prevent preterm delivery in twin gestations with a short cervix. Cervical cerclage may cause detrimental effects in twin gestations. Vaginal pessary for the prevention of preterm birth in women with a short cervix is currently under active investigation.