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NCT03637062 | NOT YET RECRUITING | High Risk Pregnancy

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

QH Medical Technology Ltd.

Brief Summary:

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

Condition or disease

High Risk Pregnancy

Intervention/treatment

Progesterone

pessary

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

Location Details

NCT03637062

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