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

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

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Pregnancy
• Intervention / Treatment: Device: pessary; Drug: Progesterone

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
• Enrollment (Estimated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Utrogestan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's birth and survival（rate）	Child's birth and survival	34+0 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Birth weight of Offspring(g)	median weight (g) of the newborns at birth	before 37+0 weeks
Fetal or neonatal death （rate）	rate of intrauterine demise or neonatal death during the first 24 hours	before 37+0 weeks
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
Harm from intervention（Case Report Form）	Harm from intervention	before 37+0 weeks
Maternal death（rate）	Maternal death	before 37+0 weeks
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
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
Rupture of membranes before 32 weeks for mother（rate）	rate of rupture of amniotic membranes before 31+6 weeks	before 37+0 weeks
inflammation 3rd stage of chorioamnionitis（rate）	inflammation 3rd stage of chorioamnionitis	before 37+0 weeks
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

Collaborators and Investigators

• Sponsor: QH Medical Technology Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: QH-20170928

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No