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

November 14, 2023 updated by: QH Medical Technology Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child's birth and survival（rate）
Time Frame: 34+0 weeks
Child's birth and survival
34+0 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
before 37+0 weeks
Birth weight of Offspring(g)
Time Frame: before 37+0 weeks
median weight (g) of the newborns at birth
before 37+0 weeks
Fetal or neonatal death （rate）
Time Frame: before 37+0 weeks
rate of intrauterine demise or neonatal death during the first 24 hours
before 37+0 weeks
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)
before 37+0 weeks
Harm from intervention（Case Report Form）
Time Frame: before 37+0 weeks
Harm from intervention
before 37+0 weeks
Maternal death（rate）
Time Frame: before 37+0 weeks
Maternal death
before 37+0 weeks
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
before 37+0 weeks
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
before 37+0 weeks
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
before 37+0 weeks
inflammation 3rd stage of chorioamnionitis（rate）
Time Frame: before 37+0 weeks
inflammation 3rd stage of chorioamnionitis
before 37+0 weeks
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
before 37+0 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
QH Medical Technology Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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