Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix (PWK)
Primary Purpose
Preterm Birth
Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Arabin cervical pessary
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility 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
Sites / Locations
- University of Naples Federico II
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cervical pessary
Standard care
Arm Description
Arabin cervical pessary
No treatment
Outcomes
Primary Outcome Measures
Spontaneous preterm birth (SPTB)
Secondary Outcome Measures
Spontaneous preterm birth (SPTB)
Gestational age at delivery
mean gestational age at delivery
Latency
mean latency in days (from randomization to delivery)
Birth weight
mean birth weight in grams
Admission to neonatal intensive care unit
respiratory distress syndrome
low birth weight
birth weight <2500 grams
intraventricular hemorrhage
grade 3 or 4
neonatal mortality
death of a live-born baby within the first 28 days of life
Full Information
NCT ID
NCT02849301
First Posted
July 27, 2016
Last Updated
November 15, 2018
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02849301
Brief Title
Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
Acronym
PWK
Official Title
Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
different protocol started, new registration
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical pessary
Arm Type
Experimental
Arm Description
Arabin cervical pessary
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Device
Intervention Name(s)
Arabin cervical pessary
Primary Outcome Measure Information:
Title
Spontaneous preterm birth (SPTB)
Time Frame
Less than 34 weeks gestation
Secondary Outcome Measure Information:
Title
Spontaneous preterm birth (SPTB)
Time Frame
Less than 37,35,32,28 and 24 weeks gestation
Title
Gestational age at delivery
Description
mean gestational age at delivery
Time Frame
Delivery (at birth)
Title
Latency
Description
mean latency in days (from randomization to delivery)
Time Frame
Delivery (at birth)
Title
Birth weight
Description
mean birth weight in grams
Time Frame
Delivery (at birth)
Title
Admission to neonatal intensive care unit
Time Frame
Delivery (at birth)
Title
respiratory distress syndrome
Time Frame
Delivery (at birth)
Title
low birth weight
Description
birth weight <2500 grams
Time Frame
Delivery (at birth)
Title
intraventricular hemorrhage
Description
grade 3 or 4
Time Frame
Between birth and 28 days of age
Title
neonatal mortality
Description
death of a live-born baby within the first 28 days of life
Time Frame
Between birth and 28 days of age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
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Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
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