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Not yet recruiting NCT03637062

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

No phase Interventional High Risk Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progesterone, pessary.
Who it may be relevant to
Registry conditions: High Risk Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Child's birth and survival（rate） [Time frame: 34+0 weeks]
Secondary outcome measures (11)
  • Time to birth of Offspring（gestational weeks） [Time frame: before 37+0 weeks]
  • Birth weight of Offspring(g) [Time frame: before 37+0 weeks]
  • Fetal or neonatal death （rate） [Time frame: before 37+0 weeks]
  • Neonatal morbidity （rate） [Time frame: before 37+0 weeks]
  • Harm from intervention（Case Report Form） [Time frame: before 37+0 weeks]
  • Maternal death（rate） [Time frame: before 37+0 weeks]
  • Significant maternal adverse events (rate) [Time frame: before 37+0 weeks]
  • Physical or psychological intolerance to pessary for mother(number of cases) [Time frame: before 37+0 weeks]
  • Rupture of membranes before 32 weeks for mother（rate） [Time frame: before 37+0 weeks]
  • inflammation 3rd stage of chorioamnionitis（rate） [Time frame: before 37+0 weeks]
  • Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form） [Time frame: before 37+0 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 36453699

Identifiers

NCT: NCT03637062 · QH-20170928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗