Clinical trial NCT02716909: Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Official title: Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 300
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: Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Singleton pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa

Primary outcomes:
measure: Spontaneous preterm birth (SPTB) <34 weeks
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: SPTB <37w
timeFrame: Less than 37 weeks gestation
measure: SPTB <32w
timeFrame: Less than 32 weeks gestation
measure: SPTB <28w
timeFrame: Less than 32 weeks gestation
measure: Gestational age at delivery
timeFrame: Time of delivery
measure: Latency
timeFrame: time of delivery
measure: preterm premature rupture of membranes
timeFrame: Less than 34 weeks gestation
measure: Type of delivery
timeFrame: time of delivery
measure: Maternal side effects
timeFrame: Time of delivery
measure: Birth weight
timeFrame: Time of delivery
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: perinatal death
timeFrame: fetal death after 20 weeks
measure: Composite adverse perinatal outcome
timeFrame: Between birth and 28 days of age
measure: Chorioamnionitis
timeFrame: Time of delivery
measure: Adminssion to neonatal intensive care unit
timeFrame: Between birth and 28 days of age
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
References:
citation: Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956.