Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

Launched by QH MEDICAL TECHNOLOGY LTD. · Aug 15, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a device called a cerclage pessary, which is designed to help prevent and treat preterm labor in women who are at high risk for having their babies too early. The study aims to see if this device is safe and effective for women who have previously had a preterm birth before 34 weeks of pregnancy or have experienced late miscarriage. Women between 18 and 40 weeks of pregnancy who meet these criteria may be eligible to participate.

If you join this study, you’ll receive the cerclage pessary, and doctors will monitor your pregnancy closely to see how well it works for you. Before joining, there are some important health factors to consider, such as not having certain medical conditions or complications that could affect the use of the pessary. This study is not yet recruiting participants, but it’s an important step towards helping women at risk of preterm labor have healthier pregnancies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and/or a history of late abortion
• • 12+0 -18+0 weeks of gestation
• • Minimal age of 18 years
• • Informed consent signature
• Exclusion Criteria:
• • The previous preterm delivery is iatrogenic proterm labor
• • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
• • The pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary
• • The pregnant woman with uterine cervicitis
• • The pregnant woman that has been confirmed premature birth
• • Cerclage prior to randomisation
• • Cerclage prior to randomisation
• • Placenta previa totalis
• • Active vaginal bleeding at the moment of randomization
• • Spontaneous rupture of membranes at the time of randomization
• • Silicone allergy
• • Painful regular uterine contractions
• • The pregnant woman have the indication of operation cervical cerclage
• • Current participation in other RCT