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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-12-01

Brief Summary

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

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Detailed Description

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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).

Conditions

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High Risk Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open Multicentre Randomized Controlled Trial, in parallel groups, based on treatment with progesterone comparing the placement of a prophylactic cervical pessary with usual management in singleton pregnancies at high-risk of PTB due to a history of at least one previous preterm delivery and/or a history of late abortion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pessary

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.

Group Type EXPERIMENTAL

pessary

Intervention Type DEVICE

pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.

Progesterone

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

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

progeaterone:Utrogestan is one of the normal drugs in China to prevent spontaneous preterm birth, the Utrogestan used in this study is from Laboratories Besins International.

Interventions

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Progesterone

progeaterone:Utrogestan is one of the normal drugs in China to prevent spontaneous preterm birth, the Utrogestan used in this study is from Laboratories Besins International.

Intervention Type DRUG

pessary

pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.

Intervention Type DEVICE

Other Intervention Names

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Utrogestan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes