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

F

Federico II University

Status and phase

Withdrawn
Phase 3

Conditions

Preterm Birth

Treatments

Device: Arabin cervical pessary

Study type

Interventional

Funder types

Other

Identifiers

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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