Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Study Overview
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Brief Summary
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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

Official Title
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Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Arabin cervical pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical pessary<br>Arabin cervical pessary | Device: Arabin cervical pessary<br> <br> |
| No Intervention: Standard care<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth (SPTB) |  | Less than 34 weeks gestation | 

Secondary Outcome Measures

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