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NCT Number: NCT03637062

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

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

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Key information

Conditions

High Risk Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Utrogestan

Pessary

Device

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

Primary outcomes

  1. Child's birth and survival（rate）

    Time frame: 34+0 weeks

    Child's birth and survival

Secondary outcomes

  1. Time to birth of Offspring（gestational weeks）

    Time frame: before 37+0 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

  2. Birth weight of Offspring(g)

    Time frame: before 37+0 weeks

    median weight (g) of the newborns at birth

  3. Fetal or neonatal death （rate）

    Time frame: before 37+0 weeks

    rate of intrauterine demise or neonatal death during the first 24 hours

  4. Neonatal morbidity （rate）

    Time frame: before 37+0 weeks

    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)

  5. Harm from intervention（Case Report Form）

    Time frame: before 37+0 weeks

    Harm from intervention

  6. Maternal death（rate）

    Time frame: before 37+0 weeks

    Maternal death

  7. Significant maternal adverse events (rate)

    Time frame: before 37+0 weeks

    • 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

  8. Physical or psychological intolerance to pessary for mother(number of cases)

    Time frame: before 37+0 weeks

    discomfort or pain due to the pessary that makes daily life uncomfortable

  9. Rupture of membranes before 32 weeks for mother（rate）

    Time frame: before 37+0 weeks

    rate of rupture of amniotic membranes before 31+6 weeks

  10. inflammation 3rd stage of chorioamnionitis（rate）

    Time frame: before 37+0 weeks

    inflammation 3rd stage of chorioamnionitis

  11. Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form）

    Time frame: before 37+0 weeks

    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

Sponsors and collaborators

Lead sponsor

QH Medical Technology Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2018
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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