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

High Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03637062
• Other study ID #: QH-20170928
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2023
• Source: QH Medical Technology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Risk Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
QH Medical Technology Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child's birth and survival(rate)	Child's birth and survival	34+0 weeks
Secondary	Time to birth of Offspring(gestational 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	before 37+0 weeks
Secondary	Birth weight of Offspring(g)	median weight (g) of the newborns at birth	before 37+0 weeks
Secondary	Fetal or neonatal death (rate)	rate of intrauterine demise or neonatal death during the first 24 hours	before 37+0 weeks
Secondary	Neonatal morbidity (rate)	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)	before 37+0 weeks
Secondary	Harm from intervention(Case Report Form)	Harm from intervention	before 37+0 weeks
Secondary	Maternal death(rate)	Maternal death	before 37+0 weeks
Secondary	Significant maternal adverse events (rate)	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	before 37+0 weeks
Secondary	Physical or psychological intolerance to pessary for mother(number of cases)	discomfort or pain due to the pessary that makes daily life uncomfortable	before 37+0 weeks
Secondary	Rupture of membranes before 32 weeks for mother(rate)	rate of rupture of amniotic membranes before 31+6 weeks	before 37+0 weeks
Secondary	inflammation 3rd stage of chorioamnionitis(rate)	inflammation 3rd stage of chorioamnionitis	before 37+0 weeks
Secondary	Hospitalisation for threatened preterm labour before 32 weeks(Case Report Form)	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	before 37+0 weeks