Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.
Child's birth and survival（rate）
Child's birth and survival
Time frame: 34+0 weeks
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
Time frame: before 37+0 weeks
Birth weight of Offspring(g)
median weight (g) of the newborns at birth
Time frame: before 37+0 weeks
Fetal or neonatal death （rate）
rate of intrauterine demise or neonatal death during the first 24 hours
Time frame: 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)
Time frame: before 37+0 weeks
Harm from intervention（Case Report Form）
Harm from intervention
Time frame: before 37+0 weeks
Maternal death（rate）
Maternal death
Time frame: before 37+0 weeks
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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
Time frame: 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
Time frame: before 37+0 weeks
Rupture of membranes before 32 weeks for mother（rate）
rate of rupture of amniotic membranes before 31+6 weeks
Time frame: before 37+0 weeks
inflammation 3rd stage of chorioamnionitis（rate）
inflammation 3rd stage of chorioamnionitis
Time frame: 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
Time frame: before 37+0 weeks