Clinical trial NCT02678026: Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Official title: Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) \< 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination.

Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage.

The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Singleton gestations
* Women with prior preterm birth and with short cervical length (TVU CL \<25 mm) who underwent UIC

Exclusion Criteria:

* multiple gestation
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina
* Painful regular uterine contractions
* Labor
* Placenta previa

Primary outcomes:
measure: Preterm delivery
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: Time of delivery
measure: Birth weight
timeFrame: Time of delivery
measure: Spontaneous preterm birth rates
timeFrame: Less than 24, 28, 34 and 37 weeks gestation
measure: Spontaneous rupture of membranes
timeFrame: Less than 34 weeks gestation
measure: Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
timeFrame: Time of delivery
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: Composite adverse neonatal outcome
timeFrame: Between birth and 28 days of age
measure: Admission to neonatal intensive care unit
timeFrame: Between birth and 28 days of age
measure: Chorioamnionitis
timeFrame: Time of delivery
measure: significant adverse maternal effects
timeFrame: Time of delivery
measure: Intolerance to pessary
timeFrame: prior to delivery
measure: Preterm delivery
timeFrame: Less than 24, 28 and 37 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.