Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

NCT ID: NCT02849301

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-03-31

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

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervical pessary

Arabin cervical pessary

Group Type: EXPERIMENTAL

Arabin cervical pessary

Intervention Type: DEVICE

Standard care

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Arabin cervical pessary

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Naples, , Italy

Countries

Italy

Other Identifiers

2378

Identifier Type: -

Identifier Source: org_study_id