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

QH Medical Technology

Status: Not yet enrolling

Conditions: High Risk Pregnancy

Treatments: Device: pessary; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03637062

QH-20170928

Details and patient eligibility

About

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

Full description

Prospective Open-label Multicentre Randomized Controlled Trial. high-risk preterm pregnancy is that there are at least one history of spontaneous preterm birth and/or late abortion before 34+0 weeks, for high-risk pregnant women that meet the inclusion criteria, the early treatment with cerclage pessary at 12-18weeks compare with routine treatment. The patients will be informed of the intended therapeutic effect and possible side effects. If they agree and after obtaining their informed consent, they will be randomized to test group (cerclage pessary group) and control group (Utrogestan group).

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

pessary

Experimental group

Description:

the test group is pessary.The pregnant woman is assigned to the pessary group and after having excluded a vaginal infection the pessary will be inserted directly.

Treatment:

Device: pessary

Progesterone

Active Comparator group

Description:

the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks.

Treatment:

Drug: Progesterone