Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Preterm Birth Clinical Trial

— PWK  

Official title:

Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02849301
• Other study ID #: 2378
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: November 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Device:
• Arabin cervical pessary

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous preterm birth (SPTB)		Less than 34 weeks gestation
Secondary	Spontaneous preterm birth (SPTB)		Less than 37,35,32,28 and 24 weeks gestation
Secondary	Gestational age at delivery	mean gestational age at delivery	Delivery (at birth)
Secondary	Latency	mean latency in days (from randomization to delivery)	Delivery (at birth)
Secondary	Birth weight	mean birth weight in grams	Delivery (at birth)
Secondary	Admission to neonatal intensive care unit		Delivery (at birth)
Secondary	respiratory distress syndrome		Delivery (at birth)
Secondary	low birth weight	birth weight <2500 grams	Delivery (at birth)
Secondary	intraventricular hemorrhage	grade 3 or 4	Between birth and 28 days of age
Secondary	neonatal mortality	death of a live-born baby within the first 28 days of life	Between birth and 28 days of age