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Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Primary Purpose

Preterm Labor

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cervical pessary
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor focused on measuring cervical pessary, preterm labor, Cervical insufficiency

Eligibility Criteria

17 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with a cervical length of 25 mm> and a preterm labor history in the previous pregnancy

Exclusion Criteria:

  • Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis

Sites / Locations

  • Zeynep Kamil Maternity and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

short cervix group

group with cervical insufficiency

Arm Description

cervical pessary in group with first pregnancy or no preterm labor

cervical pessary in group with multiple preterm labor

Outcomes

Primary Outcome Measures

Preterm delivery
Spontaneous delivery before 34 completed weeks

Secondary Outcome Measures

Full Information

First Posted
March 25, 2017
Last Updated
March 29, 2017
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03096691
Brief Title
Use of Pessary in Case of Cervical Insufficiency and Short Cervix
Official Title
Use of Pessary in Case of Cervical Insufficiency and Short Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
March 30, 2017 (Anticipated)
Study Completion Date
March 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prematurity is the most important cause of obstetric morbidity and mortality. Health centers and obstetricians are trying to reduce the preterm birth rate by taking into account the permanent effects of premature birth on human life in the early and long term. The most effective solution of preterm delivery is to determine the patients entering the risk group and to prevent preterm labor by putting the correct diagnosis at the right time. Recently, there have been studies on the efficacy of pessary practice in preventing preterm birth, but with the positive results of these studies, there has been hope for early birth prevention as well as other treatments. The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.
Detailed Description
The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency. 100 pregnant women with a preterm delivery history and / or a cervical length of less than 25 mm will be included among the pregnancies between 16 and 24 weeks of gestation referred to obstetric and perinatology clinics. Information will be given about the success of treatment in the prevention of early birth of the pessary and the use of the disease pessary. Urine culture and cervical culture samples will be taken from both groups of patients. In the presence of infection, the patient's treatment will be planned and out of work. If no infection is detected and the patient agrees to use the pessary, the pessary will be used to prevent premature birth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
cervical pessary, preterm labor, Cervical insufficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
100 pregnant women with a preterm delivery history and / or a cervical length of less than 25 mm will be included among the pregnancies between 16 and 24 weeks of gestation referred to obstetric and perinatology clinics. Information about the use of disease pessaries and treatment success in preventing premature birth of the pessary will be provided. Urine culture and cervical culture samples will be taken from both groups of patients. In the presence of infection, the patient's treatment will be planned and out of work. If no infection is detected and the patient agrees to use the pessary, the pessary will be used to prevent premature birth.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short cervix group
Arm Type
Active Comparator
Arm Description
cervical pessary in group with first pregnancy or no preterm labor
Arm Title
group with cervical insufficiency
Arm Type
Active Comparator
Arm Description
cervical pessary in group with multiple preterm labor
Intervention Type
Device
Intervention Name(s)
cervical pessary
Other Intervention Name(s)
arabin pessary
Intervention Description
Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.
Primary Outcome Measure Information:
Title
Preterm delivery
Description
Spontaneous delivery before 34 completed weeks
Time Frame
Less than 34 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with a cervical length of 25 mm> and a preterm labor history in the previous pregnancy Exclusion Criteria: Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dilsad herkiloglu, MD
Phone
5428423742
Email
dilsadherkiloglu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dilsad herkiloglu, MD
Organizational Affiliation
Zeynep Kamil Maternity and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeynep Kamil Maternity and Children's Hospital
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dilsad herkiloglu, MD
Phone
5428423742
Email
dilsadherkiloglu@hotmail.com
First Name & Middle Initial & Last Name & Degree
dilsad herkiloglu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26981934
Citation
Nicolaides KH, Syngelaki A, Poon LC, Picciarelli G, Tul N, Zamprakou A, Skyfta E, Parra-Cordero M, Palma-Dias R, Rodriguez Calvo J. A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth. N Engl J Med. 2016 Mar 17;374(11):1044-52. doi: 10.1056/NEJMoa1511014.
Results Reference
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PubMed Identifier
22475493
Citation
Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. Erratum In: Lancet. 2012 May 12;379(9828):1790.
Results Reference
background
PubMed Identifier
19796732
Citation
Dharan VB, Ludmir J. Alternative treatment for a short cervix: the cervical pessary. Semin Perinatol. 2009 Oct;33(5):338-42. doi: 10.1053/j.semperi.2009.06.008.
Results Reference
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Use of Pessary in Case of Cervical Insufficiency and Short Cervix

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