The learning curve in silicone ring around uterine cervix

Not Applicable

• Conditions: Maternal care for cervical incompetence; Preterm labor; preterm labor with preterm delivery; preterm labor with term delivery; O34.3; O60.1; O60.2

• Registration Number: RBR-46rgjc
• Lead Sponsor: niversidade Federal de São Paulo - UNIFESP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Pregnant women between 18th to 24th week of gestation with cervical length lower or equal 25 mm

Exclusion Criteria

Cervical cerclage in current pregnancy; Greater than 1 cm cervical dilatation; Painful uterine activity; Labor; Rupture of membranes; Protrusion of membranes in the gynecological examination; Active vaginal bleeding; Placenta previa; Severe hepatic disease; Cholestasis during pregnancy; Thromboembolic event during pregnancy; multiple pregnancies; Major fetal abnormalities; Fetal death

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease of rate of preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum, determining the learning curve.

Secondary Outcome Measures

Name	Time	Method
Evaluate the increase of the gestational age at birth, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.<br><br>;Evaluate the increase of the birthweigth, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the difference in individual performance of responsible researchers, regarding gestational age at inclusion, cervical length at inclusion and gestational age at delivery, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the Odds Ratio for preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.;Evaluate the Kaplan-Meyer Survival analysis for preterm birth below 34 weeks, by means of cervical pessary plus progesterone, from a detection of at least 50% variation on the cumulative sum.