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

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ClinicalTrials.gov Identifier: NCT02849301
Recruitment Status : Withdrawn (different protocol started, new registration)
First Posted : July 29, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

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


Condition or disease Intervention/treatment Phase
Preterm Birth Device: Arabin cervical pessary Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Cervical pessary
Arabin cervical pessary
Device: Arabin cervical pessary
No Intervention: Standard care
No treatment



Primary Outcome Measures :
  1. Spontaneous preterm birth (SPTB) [ Time Frame: Less than 34 weeks gestation ]

Secondary Outcome Measures :
  1. Spontaneous preterm birth (SPTB) [ Time Frame: Less than 37,35,32,28 and 24 weeks gestation ]
  2. Gestational age at delivery [ Time Frame: Delivery (at birth) ]
    mean gestational age at delivery

  3. Latency [ Time Frame: Delivery (at birth) ]
    mean latency in days (from randomization to delivery)

  4. Birth weight [ Time Frame: Delivery (at birth) ]
    mean birth weight in grams

  5. Admission to neonatal intensive care unit [ Time Frame: Delivery (at birth) ]
  6. respiratory distress syndrome [ Time Frame: Delivery (at birth) ]
  7. low birth weight [ Time Frame: Delivery (at birth) ]
    birth weight <2500 grams

  8. intraventricular hemorrhage [ Time Frame: Between birth and 28 days of age ]
    grade 3 or 4

  9. neonatal mortality [ Time Frame: Between birth and 28 days of age ]
    death of a live-born baby within the first 28 days of life



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849301


Locations
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Italy
University of Naples Federico II
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University

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Responsible Party: Gabriele Saccone, MD, Federico II University
ClinicalTrials.gov Identifier: NCT02849301     History of Changes
Other Study ID Numbers: 2378
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications