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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: QH Medical Technology Ltd.
• Treatments: Progesterone

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