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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Jul 2016

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

July 1, 2016

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed

Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

July 27, 2016

Last Update Submit

November 15, 2018

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

Spontaneous preterm birth (SPTB)
Less than 34 weeks gestation

Secondary Outcomes (9)

Spontaneous preterm birth (SPTB)
Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery
Delivery (at birth)
Latency
Delivery (at birth)
Birth weight
Delivery (at birth)
Admission to neonatal intensive care unit
Delivery (at birth)
+4 more secondary outcomes

Study Arms (2)