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

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ClinicalTrials.gov Identifier: NCT03637062
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
High Risk Pregnancy Drug: Progesterone Device: pessary Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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

Active Comparator: Progesterone
the control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks.
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.
Other Name: Utrogestan




Primary Outcome Measures :
  1. Child's birth and survival(rate) [ Time Frame: 34+0 weeks ]
    Child's birth and survival


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Study Documents (Full-Text)

Documents provided by QH Medical Technology Ltd.:
Study Protocol  [PDF] June 12, 2018


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Responsible Party: QH Medical Technology Ltd.
ClinicalTrials.gov Identifier: NCT03637062     History of Changes
Other Study ID Numbers: QH-20170928
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs