Cervical pessary for the prevention of preterm delivery.

Not Applicable

• Conditions: Preterm Delivery

• Registration Number: JPRN-UMIN000025404
• Lead Sponsor: Department of Obstetrics and Gynecology Nagoya City University, Graduate School of Medical Sciences

Brief Summary

The results of this trial suggested that cervical pessary did not reduce preterm delivery, but may delay shortening of cervical length. Vaginal discharge was increased by using cervical pessary, no other adverse events were observed. There were no cases of intrauterine fetal demise in both groups. Cervical pessary may shorten duration of hospitalization and medication. In conclusion, cervical pessary may become one of a choice of prophylactic treatment for preterm delivery.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-15
• Study Completion: 2020-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 237

Inclusion Criteria

Not provided

Exclusion Criteria

1)Women with multiple pregnant. 2)Majior fetal anomalies. 3)Painful regular uterine contractions. 4)Active vaginal bleeding. 5)Placenta previa. 6)Cervical myoma. 7)History of cone biopsy or cervical cerclage in situ. 8)Other pregnant women when study doctores conclude that they are not eligible for study enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delivery less than 34 weeks gestation.

Secondary Outcome Measures

Name	Time	Method
A)Efficacy Delivery less than 37weeks, Delivery less than 28weeks, Rupture of membrane less than 34 weeks B)maternal background age, pregnancy history, previous medical history, hight, body weight, smoking C)Safty Way of delivery, Bleeding at delivery, Cevical laceration, Uterus rupture, pessaty withdrawal, Chorioamnionitis, Vaginitis D)Treatment for mother Cervical length, corticosteroid treatment for fetal maturation E)Background for baby body weight, Gestational weeks at birth, Apgar score, Evaluation fo umbilical arterial blood gas F)Safty for baby Fetal death, Neonatal death, Adverse outcomes(Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis) G)Treatment for baby Respiratory treatment, Photo therapy, Antibiotics, Blood transfurion