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

NCT03637062 | Not Yet Recruiting

• 1 other identifier: QH-20170928
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• Child's birth and survival（rate）

  Child's birth and survival

  34+0 weeks

Secondary Outcomes (11)

• Time to birth of Offspring（gestational weeks）

  before 37+0 weeks

• Birth weight of Offspring(g)

  before 37+0 weeks

• Fetal or neonatal death （rate）

  before 37+0 weeks

• Neonatal morbidity （rate）

  before 37+0 weeks

• Harm from intervention（Case Report Form）

  before 37+0 weeks

Study Arms (2)

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.

Device: pessary

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.

Drug: Progesterone

Interventions

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.

Also known as: Utrogestan

Progesterone

pessary DEVICE

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

pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• +0 -18+0 weeks of gestation
• Minimal age of 18 years
• Informed consent signature

You may not qualify if:

• 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

Sponsors & Collaborators

• QH Medical Technology Ltd.: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Progesterone; Utrogestan; Pessaries

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 17, 2018
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11