Preterm BirthNCT05267717
Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth
An observational study of Preterm Birth, run by Asklepios proresearch at 1 site in Germany.
Trial summary
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more than a half of overall perinatal mortality. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 23 Nov 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population Determining a study eligibility will occur on a first visit. Since our research will be longitudinal and cohort study, two cohorts of subjects to enable a cross group differences comparison will be distinguished: the pessary and the normal (non-pessary) cohort. Sample size calculation In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited). Currently, it is difficult to perform a formal power analysis since the primarx System is a novel device and limited underlying clinical data exists.
Who may be able to join
- All participants must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study.
- Moreover both for a pessary cohort and for a normal cohort additional cohort-specific criteria for each group will need to be met. For the pessary cohort those shall consist of: suspected short cervix and confirmed on TVUS (CL < 3rd percentile at gestational age at measurement) according to Salomon at al, whilst for the control (no-pessary) group: asymptomatic pregnant women with no risk factors for spontaneous preterm birth, respectively
Who cannot join
- Any possible exclusion criteria will be evaluated for an ineligibility for the study on a first visit. Exclusion criteria for both pessary and control group will be: evidence of fetal anomaly or fetal chromosomal abnormality from fetal ultrasound, uterine malformations, a history of diethylstilboestrol (DES) use, (cases of so-called so called DES daughters, who were exposed to DES in utero), a cervical cerclage or pessary currently in place, a silicone allergy, painful regular contractions, abnormal placentation (previa, accrete), the rupture of membranes, a cervical dilation, any visible, symptomatic cervical or vaginal infections (this excludes treated, asymptomatic infections), a known HIV infection, cervical carcinoma, the presence on the cervix at the 12 o'clock position of any of the following conditions: Nabothian cyst, cervical myomas, cervical condylomas, cervical endometriosis, cervical tears, scar tissue, cervical ectopy, cervical scarring due to prior LLETZ, cervical squamous intraepithelial lesion, cervical dysplasia, cone biopsy, a vaginal bleeding evident on exam.
- The exclusion criteria about conditions on the cervix at 12 o'clock position cannot be checked without being enrolled in the study as it is an extra study assessment. Therefore, participants will be enrolled, the speculum assessment will be done after enrolment to clarify if any condition on the cervix at 12 o'clock position according to the exclusion criterion is present. If yes, the woman needs to be excluded from the study shortly after enrolment. These subjects will be replaced to reach the total number calculated.
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
ASKLEPIOS proresearch, Department of Pre-and Perinatal Medicine, Asklepios Barmbek, Hamburg-Barmbek, Germany.
Hamburg, Lohmühlenstraße 5/Haus J,, 20099
Ioanis Kyvernitakis, Prof. dr. med., +4917682487002, i.kyvernitakis@asklepios.com
Ioannis Kyvernitakis, Prof.
About this study
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more than a half of overall perinatal mortality. Several studies have shown a significant therapeutic benefit as a result of an antenatal cervical pessary use in a high-risk preterm birth group of pregnant women. However the underlying mechanism by which pessary can reduce a risk of a preterm birth remain elusive. The study aims to quantitatively assess an ectocervical stiffness in a normal and in a treated with a pessary high-risk preterm birth pregnancy.
Methods: A prospective, non-interventional, post-market, monocentric, longitudinal, cohort study in a obstetric-led tertiary maternity teaching hospital to determine ectocervical stiffness and its changes measured prior and after the placement of a pessary, and the correlation of measured cervical stiffness or its changes with birth outcome in a high-risk preterm birth pregnant women indicated for cervical pessary. A cervical stiffness measured with Pregnolia system as the Cervical Stiffness Index (CSI, in mbar) will be a primary, whilst patient delivery data (gestational age, mode of delivery and complications) will be a secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited).
Discussion: We hypothesize than the study will substantially improve our knowledge about cervical incontinency and preterm labour pathophysiology. We hope that our investigation will be able to elucidate ectocervical stiffness phenomenon both in high-risk preterm birth and in normal pregnant control, as well as the impact of cervical pessary use on a the CSI values.
- Conditions
- Preterm Birth
- Being tested
- Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness
- Keywords
- Preterm Birth, Cervical stiffness, Risk assessment, Pregnolia System
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical StiffnessOther
Non-interventional study,
| Study group | Role | What they receive |
|---|---|---|
| Control/Normal (no-pessary) group | All participants will must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study.
Moreover for a normal cohort are being enrolled only asymptomatic pregnant women with no risk factors for spontaneous preterm birth Receives: Other: Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness | |
| Pessarry group | All participants will must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study.
Moreover both for a pessary cohort additional cohort-specific criteria need to be met. Those are: suspected short cervix and confirmotian with transvaginal ultrasound - TVUS (CL < 3rd percentile at gestational age at measurement) according to Salomon at al. Receives: Other: Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Stiffness Index
The primary objective is to determine the absolute value of CSI (Cervical Stiffness Index) and its change over time in women undergoing pessary treatment, in comparison to normal pregnancies, when measured at 18+0 to 24+6 weeks and at the follow-up visit (4 weeks later).
Measured: The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)
Secondary outcomes (1)
the correlation of the initial CSI and CSI changes with birth outcome
The secondary objective is to determine the correlation of the initial CSI and CSI changes with birth outcome (gestational age at birth). The safety objective is the safety of the device, by assessing incidence, severity and seriousness of device-related adverse events.
Measured: The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start23 Nov 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AG Pregnolia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267717
- Sponsor's protocol ID
- #4011
- Status last verified
- Jan 2022
- First submitted
- 24 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth
- ClinicalTrials.gov ID
- NCT05267717
- Acronym / sponsor ID
- #4011
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Cervical stiffness, Risk assessment, Pregnolia System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- AG Pregnolia
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more than a half of overall perinatal mortality. Several studies have shown a significant therapeutic benefit as a result of an antenatal cervical pessary use in a high-risk preterm birth group of pregnant women. However the underlying mechanism by which pessary can reduce a risk of a preterm birth remain elusive. The study aims to quantitatively assess an ectocervical stiffness in a normal and in a treated with a pessary high-risk preterm birth pregnancy.
Methods: A prospective, non-interventional, post-market, monocentric, longitudinal, cohort study in a obstetric-led tertiary maternity teaching hospital to determine ectocervical stiffness and its changes measured prior and after the placement of a pessary, and the correlation of measured cervical stiffness or its changes with birth outcome in a high-risk preterm birth pregnant women indicated for cervical pessary. A cervical stiffness measured with Pregnolia system as the Cervical Stiffness Index (CSI, in mbar) will be a primary, whilst patient delivery data (gestational age, mode of delivery and complications) will be a secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited).
Discussion: We hypothesize than the study will substantially improve our knowledge about cervical incontinency and preterm labour pathophysiology. We hope that our investigation will be able to elucidate ectocervical stiffness phenomenon both in high-risk preterm birth and in normal pregnant control, as well as the impact of cervical pessary use on a the CSI values.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control/Normal (no-pessary) group | – | Other: Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical StiffnessAll participants will must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study. Moreover for a normal cohort are being enrolled only asymptomatic pregnant women with no risk factors for spontaneous preterm birth |
| Pessarry group | – | Other: Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical StiffnessAll participants will must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study. Moreover both for a pessary cohort additional cohort-specific criteria need to be met. Those are: suspected short cervix and confirmotian with transvaginal ultrasound - TVUS (CL < 3rd percentile at gestational age at measurement) according to Salomon at al. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population Determining a study eligibility will occur on a first visit. Since our research will be longitudinal and cohort study, two cohorts of subjects to enable a cross group differences comparison will be distinguished: the pessary and the normal (non-pessary) cohort. Sample size calculation In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) completed the study; Pessary cohort: 60 (up to 71 recruited), normal cohort: 60 (up to 71 recruited). Currently, it is difficult to perform a formal power analysis since the primarx System is a novel device and limited underlying clinical data exists.
Key inclusion criteria (2 listed)
- All participants must meet the criteria in order to be eligible: a singleton gestation, pregnant women recruited between 18+0 - 24+6 weeks of gestation, maternal age ≥18 years, the ability to sign approved consent form to participate in the study.
- Moreover both for a pessary cohort and for a normal cohort additional cohort-specific criteria for each group will need to be met. For the pessary cohort those shall consist of: suspected short cervix and confirmed on TVUS (CL < 3rd percentile at gestational age at measurement) according to Salomon at al, whilst for the control (no-pessary) group: asymptomatic pregnant women with no risk factors for spontaneous preterm birth, respectively
Key exclusion criteria (3 listed)
- Any possible exclusion criteria will be evaluated for an ineligibility for the study on a first visit. Exclusion criteria for both pessary and control group will be: evidence of fetal anomaly or fetal chromosomal abnormality from fetal ultrasound, uterine malformations, a history of diethylstilboestrol (DES) use, (cases of so-called so called DES daughters, who were exposed to DES in utero), a cervical cerclage or pessary currently in place, a silicone allergy, painful regular contractions, abnormal placentation (previa, accrete), the rupture of membranes, a cervical dilation, any visible, symptomatic cervical or vaginal infections (this excludes treated, asymptomatic infections), a known HIV infection, cervical carcinoma, the presence on the cervix at the 12 o'clock position of any of the following conditions: Nabothian cyst, cervical myomas, cervical condylomas, cervical endometriosis, cervical tears, scar tissue, cervical ectopy, cervical scarring due to prior LLETZ, cervical squamous intraepithelial lesion, cervical dysplasia, cone biopsy, a vaginal bleeding evident on exam.
- The exclusion criteria about conditions on the cervix at 12 o'clock position cannot be checked without being enrolled in the study as it is an extra study assessment. Therefore, participants will be enrolled, the speculum assessment will be done after enrolment to clarify if any condition on the cervix at 12 o'clock position according to the exclusion criterion is present. If yes, the woman needs to be excluded from the study shortly after enrolment. These subjects will be replaced to reach the total number calculated.
- -
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 |
|---|---|---|
| Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical StiffnessNon-interventional study, | Other | Control/Normal (no-pessary) group, Pessarry group |
Primary outcome
Cervical Stiffness Index
Time frame: The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)
The primary objective is to determine the absolute value of CSI (Cervical Stiffness Index) and its change over time in women undergoing pessary treatment, in comparison to normal pregnancies, when measured at 18+0 to 24+6 weeks and at the follow-up visit (4 weeks later).
1 secondary outcome
the correlation of the initial CSI and CSI changes with birth outcome
Time frame: The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
ASKLEPIOS proresearch, Department of Pre-and Perinatal Medicine, Asklepios Barmbek, Hamburg-Barmbek, Germany.
Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Asklepios proresearch at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Stiffness Index (time frame: The first visit (18+0-24+6 weeks of gestation) and the follow-up visit (4 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2022.