Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Not Applicable

• Conditions: Preterm Labor
• Interventions: Device: cervical pessary

• Registration Number: NCT03096691
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Study Timeline

• Study Start: 2016-02-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-25
• Study First Submitted QC: 2017-03-25
• Last Update Submitted: 2017-03-29
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Study First Posted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short cervix group	cervical pessary	cervical pessary in group with first pregnancy or no preterm labor
group with cervical insufficiency	cervical pessary	cervical pessary in group with multiple preterm labor

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Less than 34 weeks gestation	Spontaneous delivery before 34 completed weeks

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Children's Hospital; 🇹🇷 Istanbul, Turkey