Use of Pessary in Case of Cervical Insufficiency and Short Cervix

March 29, 2017 updated by: Dilsad Herkiloglu, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34718
        • Recruiting
        • Zeynep Kamil Maternity and Children's Hospital
        • Contact:
        • Principal Investigator:
          • dilsad herkiloglu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: short cervix group
cervical pessary in group with first pregnancy or no preterm labor
Device: cervical pessary
Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.
Other Names:
  • arabin pessary
Active Comparator: group with cervical insufficiency
cervical pessary in group with multiple preterm labor
Device: cervical pessary
Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.
Other Names:
  • arabin pessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm delivery
Time Frame: Less than 34 weeks gestation
Spontaneous delivery before 34 completed weeks
Less than 34 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Principal Investigator: dilsad herkiloglu, MD, Zeynep Kamil Maternity and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

March 30, 2017

Study Completion (Anticipated)

March 30, 2017

Study Registration Dates

First Submitted

March 25, 2017

First Submitted That Met QC Criteria

March 25, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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