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

Study Overview
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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.

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).

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

Conditions
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High Risk Pregnancy

Intervention / Treatment
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* Drug: Progesterone
* Device: pessary


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pessary<br>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. | Device: pessary<br>* pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.<br>|
| Active Comparator: Progesterone<br>the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks. | Drug: Progesterone<br>* 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.<br>* Other names: Utrogestan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's birth and survival（rate） | Child's birth and survival | 34+0 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to birth of Offspring（gestational weeks） | Preterm birth before 37 weeks: rate of delivery before 36+6 weeks Preterm birth before 34 weeks: rate of delivery before 33+6 weeks Preterm birth before 32 weeks: rate of delivery before 31+6 weeks Preterm birth before 30 weeks: rate of delivery before 29+6 weeks Preterm birth before 28 weeks: rate of delivery before 27+6 weeks | before 37+0 weeks | 
| Birth weight of Offspring(g) | median weight (g) of the newborns at birth | before 37+0 weeks | 
| Fetal or neonatal death （rate） | rate of intrauterine demise or neonatal death during the first 24 hours | before 37+0 weeks | 
| Neonatal morbidity （rate） | rate of major adverse neonatal outcomes before discharge from the hospital： Intraventricular Haemorrhage (IVH): grades III-IV Retinopathy of prematurity Respiratory Distress Syndrome (RDS): grades II-IV Need for ventilation > 72 h Necrotising enterocolitis Proven or suspected sepsis, antibiotics (>5 days) Need (Duration in days) for neonatal special care (NICU) | before 37+0 weeks | 
| Harm from intervention（Case Report Form） | Harm from intervention | before 37+0 weeks | 
| Maternal death（rate） | Maternal death | before 37+0 weeks | 
| Significant maternal adverse events (rate) | Heavy bleeding: bleeding that requires a medical intervention Cervical tear: cervical rupture due to the pessary placement Uterine rupture: rupture of the uterus due to contractions or surgery | before 37+0 weeks | 
| Physical or psychological intolerance to pessary for mother(number of cases) | discomfort or pain due to the pessary that makes daily life uncomfortable | before 37+0 weeks | 
| Rupture of membranes before 32 weeks for mother（rate） | rate of rupture of amniotic membranes before 31+6 weeks | before 37+0 weeks | 
| inflammation 3rd stage of chorioamnionitis（rate） | inflammation 3rd stage of chorioamnionitis | before 37+0 weeks | 
| Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form） | requirement of hospitalisation due to preterm contractions that need medical treatment to try to stop them before 31+6 weeks Mean hospital stay duration: number of days of admittance at the hospital Use of tocolytic treatment: Type of tocolytic, days of treatment, dose | before 37+0 weeks |