Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix (PWK)

Federico II University

Status and phase: Withdrawn; Phase 3

Conditions: Preterm Birth

Treatments: Device: Arabin cervical pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02849301

2378

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cervical pessary

Experimental group

Description:

Arabin cervical pessary

Treatment:

Device: Arabin cervical pessary

Standard care

No Intervention group

Description:

No treatment