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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pessary | Experimental | 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. |
|
| Progesterone | Active Comparator | the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child's birth and survival（rate） | Child's birth and survival | 34+0 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to birth of Offspring（gestational weeks） |
| before 37+0 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36453699 | Derived | Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2018 | Aug 6, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| D010570 | Pessaries |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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
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|
| pessary | Device | pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth. |
|
| 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：
| 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) |
| 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
| before 37+0 weeks |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |