Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Phase 3

Withdrawn

• Conditions: Preterm Birth
• Interventions: Device: Arabin cervical pessary

• Registration Number: NCT02849301
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-29
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical pessary	Arabin cervical pessary	Arabin cervical pessary

Primary Outcome Measures

Name	Time	Method
Spontaneous preterm birth (SPTB)	Less than 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Spontaneous preterm birth (SPTB)	Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery	Delivery (at birth)	mean gestational age at delivery
Admission to neonatal intensive care unit	Delivery (at birth)
intraventricular hemorrhage	Between birth and 28 days of age	grade 3 or 4
Latency	Delivery (at birth)	mean latency in days (from randomization to delivery)
Birth weight	Delivery (at birth)	mean birth weight in grams
respiratory distress syndrome	Delivery (at birth)
low birth weight	Delivery (at birth)	birth weight \<2500 grams
neonatal mortality	Between birth and 28 days of age	death of a live-born baby within the first 28 days of life

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy