NCT03096691

Use of Pessary in Case of Cervical Insufficiency and Short Cervix

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 17 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DEVICE	cervical pessary	Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-30
• Completion: 2017-03-30
• First posted: 2017-03-30
• Last updated: 2017-03-31

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study