Clinical trial NCT02849301: Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
Official title: Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-07-29
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: Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.

Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.

The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) \<25mm


Eligibility criteria: Inclusion Criteria:

* 18-50 ages
* Singleton pregnancy
* 24(0) - 34(6) weeks of gestation
* Arrested preterm labor after primary tocolysis
* Transvaginal ultrasound cervical length less than 25mm at admission
* Agreement to regular follow-up and provision of written informed consent

Exclusion Criteria:

* pessary and no cerclage in situ
* vaginal bleeding
* placeta previa/accreta
* multiple gestations
* \<24(0) or \>24(6) weeks of gestation
* Cervical dilatation greater than 3 cm
* Chorioamnionitis
* Major fetal abnormalities
* Abruptio placentae
* PPROM
* Polyhydramnios or oligohydramnios
* IUGR/FGR with or without Doppler abnormalities
* Preeclampsia or pregnancy-related hypertension

Primary outcomes:
measure: Spontaneous preterm birth (SPTB)
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Spontaneous preterm birth (SPTB)
timeFrame: Less than 37,35,32,28 and 24 weeks gestation
measure: Gestational age at delivery
timeFrame: Delivery (at birth)
measure: Latency
timeFrame: Delivery (at birth)
measure: Birth weight
timeFrame: Delivery (at birth)
measure: Admission to neonatal intensive care unit
timeFrame: Delivery (at birth)
measure: respiratory distress syndrome
timeFrame: Delivery (at birth)
measure: low birth weight
timeFrame: Delivery (at birth)
measure: intraventricular hemorrhage
timeFrame: Between birth and 28 days of age
measure: neonatal mortality
timeFrame: Between birth and 28 days of age
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: