High Risk PregnancyNCT03637062
Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy
A study testing Progesterone and pessary in people with High Risk Pregnancy, run by QH Medical Technology Ltd..
Trial summary
Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- Progesterone and pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- High Risk Pregnancy
- Being tested
- Progesterone, pessary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called Utrogestan
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.
pessaryDevice
pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's birth and survival（rate）
Child's birth and survival
Measured: 34+0 weeks
Secondary outcomes (11)
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
Measured: before 37+0 weeks
Birth weight of Offspring(g)
median weight (g) of the newborns at birth
Measured: before 37+0 weeks
Fetal or neonatal death （rate）
rate of intrauterine demise or neonatal death during the first 24 hours
Measured: 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)
Measured: before 37+0 weeks
Harm from intervention（Case Report Form）
Harm from intervention
Measured: before 37+0 weeks
Maternal death（rate）
Maternal death
Measured: 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
Measured: 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
Measured: before 37+0 weeks
Rupture of membranes before 32 weeks for mother（rate）
rate of rupture of amniotic membranes before 31+6 weeks
Measured: before 37+0 weeks
inflammation 3rd stage of chorioamnionitis（rate）
inflammation 3rd stage of chorioamnionitis
Measured: 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
Measured: before 37+0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QH Medical Technology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637062
- Sponsor's protocol ID
- QH-20170928
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36453699
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verify the Safety and Effectiveness of the Cerclage Pessary in the Prevention and Treatment of High-risk Preterm Pregnancy
- ClinicalTrials.gov ID
- NCT03637062
- Acronym / sponsor ID
- QH-20170928
- Conditions
- High Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- QH Medical Technology Ltd.University, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| pessary | Experimental | Device: pessarythe 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. |
| Progesterone | Active comparator | Drug: Progesteronethe control group is progesterone. Pregnant women in the control group were treated by 200 mg QN, it is used for 34 gestational weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneAlso: Utrogestanprogeaterone: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. | Drug | Progesterone |
| pessarypessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth. | Device | pessary |
Primary outcome
Child's birth and survival（rate）
Time frame: 34+0 weeks
Child's birth and survival
11 secondary outcomes
Time to birth of Offspring（gestational weeks）
Time frame: before 37+0 weeks
Birth weight of Offspring(g)
Time frame: before 37+0 weeks
Fetal or neonatal death （rate）
Time frame: before 37+0 weeks
Neonatal morbidity （rate）
Time frame: before 37+0 weeks
Harm from intervention（Case Report Form）
Time frame: before 37+0 weeks
Maternal death（rate）
Time frame: before 37+0 weeks
Significant maternal adverse events (rate)
Time frame: before 37+0 weeks
Physical or psychological intolerance to pessary for mother(number of cases)
Time frame: before 37+0 weeks
Rupture of membranes before 32 weeks for mother（rate）
Time frame: before 37+0 weeks
inflammation 3rd stage of chorioamnionitis（rate）
Time frame: before 37+0 weeks
Hospitalisation for threatened preterm labour before 32 weeks（Case Report Form）
Time frame: before 37+0 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 36453699Abdel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone and pessary in people with High Risk Pregnancy, run by QH Medical Technology Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's birth and survival（rate） (time frame: 34+0 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.