Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Conditions
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Preterm Labor

Intervention / Treatment
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* Device: cervical pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical pessary, preterm labor, Cervical insufficiency