Clinical trial NCT03637062: Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy
Official title: Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Risk Pregnancy
Lead sponsor: QH Medical Technology Ltd.
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Child's birth and survival（rate）
timeFrame: 34+0 weeks
Secondary outcomes:
measure: Time to birth of Offspring（gestational weeks）
timeFrame: before 37+0 weeks
measure: Birth weight of Offspring(g)
timeFrame: before 37+0 weeks
measure: Fetal or neonatal death （rate）
timeFrame: before 37+0 weeks
measure: Neonatal morbidity （rate）
timeFrame: before 37+0 weeks
measure: Harm from intervention（Case Report Form）
timeFrame: before 37+0 weeks
measure: Maternal death（rate）
timeFrame: before 37+0 weeks
measure: Significant maternal adverse events (rate)
timeFrame: before 37+0 weeks
measure: Physical or psychological intolerance to pessary for mother(number of cases)
timeFrame: before 37+0 weeks
measure: Rupture of membranes before 32 weeks for mother（rate）
timeFrame: before 37+0 weeks
measure: inflammation 3rd stage of chorioamnionitis（rate）
timeFrame: before 37+0 weeks
measure: Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form）
timeFrame: before 37+0 weeks
Other outcomes:
Locations:
Study officials:
References: