Labor, InducedPREDICTNCT05109247
Prediction of Spontaneous Onset of Labor at Term
An observational study of Labor, Induced and Labor, Obstetric, run by University Hospital, Geneva at 3 sites in Switzerland.
Trial summary
The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. 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
- Labor, Induced, Labor, Obstetric, Labor Onset
- How many people
- 429 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 22 Aug 2019to 31 Dec 2022
- How long will I take part?
- 3 Weeks
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women at 38+5 - 39 weeks of gestation who will deliver at the centers in which the study will be carried out.
Who may be able to join
- Alive fetus
- Singletons
- Cephalic presentation
- Intact membranes
- Gestational age ≥ 38 weeks and 5 days
Who cannot join
- Fetal malformations
- Symptomatic uterine contractions
- Contraindication for vaginal delivery
- Medical indication of induction of labor or elective cesarean delivery
- Maternal desire to induce labor
- Maternal negative to enrollment
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- Language barrier
- Inability to give consent
- Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):
- Müllerian anomalies with two cervices
- Severe vaginal bleeding
- Cervical dilatation
- Known HIV
- Visible, symptomatic cervical or vaginal infections
- If one of the following conditions is present on the cervix at the 12 o'clock position:
- Nabothian cyst
- Cervical myomas
- Cervical condylomas
- Squamous intraepithelial lesion
- Conization/LEEP2/LLETZ3
- Cervical endometriosis
- Cervical tears
- Cervical dysplasia
- Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
- Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Universitätsspital Basel
Basel, 4031
Hôpitaux Universitaires de Genève
Geneva, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.
- Conditions
- Labor, Induced, Labor, Obstetric, Labor Onset, Predictive Model
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous versus induced onset of labor
Number of participants who will spontaneously go into labor between the 39th and the 41st week of pregnancy versus number of participants requiring an induction of labor during the 41st week of pregnancy due to advanced gestational age
Measured: 3 weeks
Secondary outcomes (2)
Gestational age at spontaneous onset of labor
Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor
Measured: 2 weeks
Gestational age at spontaneous onset of labor
Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start22 Aug 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Labor, InducedStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc., QIAGEN Gaithersburg, Inc, Pregnolia AC
- Responsible party
- Principal investigator, Federico Migliorelli, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109247
- Sponsor's protocol ID
- 19-261
- Acronym
- PREDICT
- Status last verified
- Mar 2023
- First submitted
- 26 Oct 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Migliorelli F, Ferrero L, McCarey C, Marcenaro S, Othenin-Girard V, Chilin A, Martinez de Tejada B. Prediction of spontaneous onset of labor at term (PREDICT study): Research protocol. PLoS One. 2022 Jul 13;17(7):e0271065. doi: 10.1371/journal.pone.0271065. eCollection 2022.
PubMed 35830435
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Spontaneous Onset of Labor at Term
- ClinicalTrials.gov ID
- NCT05109247
- Acronym / sponsor ID
- PREDICT / 19-261
- Conditions
- Labor, Induced, Labor, Obstetric, Labor Onset, Predictive Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Hologic, Inc., QIAGEN Gaithersburg, Inc, Pregnolia AC
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Nov 2021 (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.
The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women at 38+5 - 39 weeks of gestation who will deliver at the centers in which the study will be carried out.
Key inclusion criteria (5 listed)
- Alive fetus
- Singletons
- Cephalic presentation
- Intact membranes
- Gestational age ≥ 38 weeks and 5 days
Key exclusion criteria (25 listed)
- Fetal malformations
- Symptomatic uterine contractions
- Contraindication for vaginal delivery
- Medical indication of induction of labor or elective cesarean delivery
- Maternal desire to induce labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spontaneous versus induced onset of labor
Time frame: 3 weeks
Number of participants who will spontaneously go into labor between the 39th and the 41st week of pregnancy versus number of participants requiring an induction of labor during the 41st week of pregnancy due to advanced gestational age
2 secondary outcomes
Gestational age at spontaneous onset of labor
Time frame: 2 weeks
Gestational age at spontaneous onset of labor
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 35830435Migliorelli F, Ferrero L, McCarey C, Marcenaro S, Othenin-Girard V, Chilin A, Martinez de Tejada B. Prediction of spontaneous onset of labor at term (PREDICT study): Research protocol. PLoS One. 2022 Jul 13;17(7):e0271065. doi: 10.1371/journal.pone.0271065. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, Induced and Labor, Obstetric, run by University Hospital, Geneva at 3 sites in Switzerland.
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 5 inclusion and 25 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: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spontaneous versus induced onset of labor (time frame: 3 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 NCT05109247, 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 28 Mar 2023.