Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SAPREDISSNCT07637318
Prediction of Labor Induction Outcome in Nulliparous Women
An observational study of Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Labor induction rates are increasing worldwide, yet nulliparous patients remain at high risk of failed induction and intrapartum cesarean delivery as well as prolonged labor which are associated with increased maternal morbidity, adverse outcomes in future pregnancies, increased neonatal morbidity and negative… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA
- What is being tested?
- Vaginal sample
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jan 2028
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Nulliparous patients
Who may be able to join
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 39 weeks
- Nulliparous
- Live foetus
- Cephalic presentation
Show all 9Show fewer
- Intact membranes
- Bishop score < 6
- Willing to participate in the study
Who cannot join
- A minor or a protected adult (under guardianship or conservatorship)
- Individuals who don't speak French or are not accompanied by a third party who speaks French
- Suspected intrauterine fetal growth restriction (estimated fetal weight < 3rd percentile or < 10th percentile with abnormal fetal Doppler)
- Presence of fetal malformations and/or genetic or chromosomal abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
AP-HP - Hôpital Cochin - Maternité Port-Royal
Paris, Île-de-France Region, 75014
About this study
Official title: Evaluation of Biomarkers in Term Labor Induction in Low-Risk Nulliparous Patients: Toward Better Prediction of Induction Outcomes
Labor induction rates are increasing worldwide, yet nulliparous patients remain at high risk of failed induction and intrapartum cesarean delivery as well as prolonged labor which are associated with increased maternal morbidity, adverse outcomes in future pregnancies, increased neonatal morbidity and negative childbirth experience. This study aims to evaluate whether macrophage activation biomarkers in cervicovaginal secretions can predict successful labor induction in low-risk nulliparous women at term with an unfavorable cervix (Bishop score <6).
The study focuses on three patented biomarkers of "imminence of delivery" (MCP1, CD14, and CD163), previously shown to be markedly elevated during spontaneous labor. We hypothesize that higher biomarker concentrations reflect biological readiness for labor and are associated with successful induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm). Secondary objectives include evaluating the association between biomarker concentrations and labor progression. Identifying reliable predictive biomarkers could improve patient selection for induction and optimize obstetrical management in nulliparous women.
Read the detailed description
The aim of labor induction is to reduce maternal and/or fetal complications associated with continuation of pregnancy while enabling vaginal delivery.
The investigators hypothesize that, at the time of induction, some key biological changes may already have occurred, thereby facilitating the initiation and progression of labor.
Our objective is to evaluate the association between the concentration of three macrophage activation biomarkers (referred to as "imminence of delivery" biomarkers) in cervicovaginal secretions (MCP1, CD14, and CD163) and successful labor induction among low-risk nulliparous women with an unfavorable cervix (Bishop score <6) at ≥39 weeks of gestation. We hypothesize that high biomarker concentrations will predict successful induction.
Pregnant women ≥ 39 weeks of gestation admitted to the maternity unit for labor induction who are eligible for the study will be approached to participate. The study procedures will be explained by the clinician (obstetrician-gynaecologist or midwife) in charge of the patient. In the absence of objection, the clinician who provided the information will complete the non-opposition form required for the patient's inclusion in the study. A cervicovaginal swab for biomarker measurement will be collected prior to labor induction.
A non-parametric Kruskal-Wallis test will be used to compare biomarker concentrations between patients who underwent caesarean delivery before 6 cm of cervical dilation and those whose labor progressed beyond 6 cm. The predictive value of biomarkers for induction success will be assessed using receiver operating characteristic (ROC) curves. The area under the curve (AUC) will be calculated with its 95% confidence interval, and the optimal threshold for each biomarker will be determined.
The predictive value of the three biomarkers will be assessed in the same manner for the following secondary outcomes: the rate of vaginal delivery within 24 hours of induction onset, the time from induction onset to delivery, and the time from induction onset to reaching 6 cm of cervical dilation.
In addition, patients will be offered the option of donating a sample of the placenta and fetal membranes (amniotic sac) following delivery. These tissues, which are not routinely preserved, will be analyzed with the aim of identifying potential new biomarkers of interest. The collection of a placental sample at delivery is not a prerequisite for participation in the study. Patients will be free to participate in the study (i.e. biomarker measurement in vaginal secretions) while objecting to the collection of a placental sample at delivery.
- Being tested
- Vaginal sample
- Keywords
- Pregnancy, Childbirth, Induction of labor, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal sampleBiological
A vaginal sample will be collected from 39 weeks of gestation onward, prior to labor induction. The vaginal swab for biomarker testing will be collected at the same time as the vaginal swab for Group B streptococcus screening (which is routinely performed as part of standard care, in accordance with clinical practice guidelines). Therefore, no additional procedure is required for this research.
| Study group | Role | What they receive |
|---|---|---|
| Nulliparous patients | In low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA Receives: Biological: Vaginal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).
Measured: Up to 7 days
Secondary outcomes (3)
The rate of vaginal delivery within 24 hours of the start of induction
Measured: Within 24hours of the start of induction
The time from the beginning of labour induction to vaginal delivery (in hours)
Measured: From the beginning of labour induction to vaginal delivery (in hours)
The time from the beginning of labour induction to 6 cm of dilation (entry into the active phase) (in hours)
Measured: From the beginning of labour induction to 6 cm of dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SAStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637318
- Sponsor's protocol ID
- APHP251724
- Other IDs
- IDRCB
- Acronym
- PREDISS
- Status last verified
- Jul 2026
- First submitted
- 18 May 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blanc-Petitjean P, Schmitz T, Salome M, Goffinet F, Le Ray C; MEDIP Study Group. Target populations to reduce cesarean rates after induced labor: A national population-based cohort study. Acta Obstet Gynecol Scand. 2020 Mar;99(3):406-412. doi: 10.1111/aogs.13751. Epub 2019 Nov 19.
PubMed 31628852Norwitz ER, Bonney EA, Snegovskikh VV, Williams MA, Phillippe M, Park JS, Abrahams VM. Molecular Regulation of Parturition: The Role of the Decidual Clock. Cold Spring Harb Perspect Med. 2015 Apr 27;5(11):a023143. doi: 10.1101/cshperspect.a023143.
PubMed 25918180Stelzer IA, Ghaemi MS, Han X, Ando K, Hedou JJ, Feyaerts D, Peterson LS, Rumer KK, Tsai ES, Ganio EA, Gaudilliere DK, Tsai AS, Choisy B, Gaigne LP, Verdonk F, Jacobsen D, Gavasso S, Traber GM, Ellenberger M, Stanley N, Becker M, Culos A, Fallahzadeh R, Wong RJ, Darmstadt GL, Druzin ML, Winn VD, Gibbs RS, Ling XB, Sylvester K, Carvalho B, Snyder MP, Shaw GM, Stevenson DK, Contrepois K, Angst MS, Aghaeepour N, Gaudilliere B. Integrated trajectories of the maternal metabolome, proteome, and immunome predict labor onset. Sci Transl Med. 2021 May 5;13(592):eabd9898. doi: 10.1126/scitranslmed.abd9898.
PubMed 33952678Socha MW, Flis W, Pietrus M, Wartega M, Stankiewicz M. Signaling Pathways Regulating Human Cervical Ripening in Preterm and Term Delivery. Cells. 2022 Nov 21;11(22):3690. doi: 10.3390/cells11223690.
PubMed 36429118Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2021. Natl Vital Stat Rep. 2023 Jan;72(1):1-53.
PubMed 36723449Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
PubMed 30089070Le Ray C, Blondel B, Prunet C, Khireddine I, Deneux-Tharaux C, Goffinet F. Stabilising the caesarean rate: which target population? BJOG. 2015 Apr;122(5):690-9. doi: 10.1111/1471-0528.13199. Epub 2014 Nov 21.
PubMed 25412695Johnson DP, Davis NR, Brown AJ. Risk of cesarean delivery after induction at term in nulliparous women with an unfavorable cervix. Am J Obstet Gynecol. 2003 Jun;188(6):1565-9; discussion 1569-72. doi: 10.1067/mob.2003.458.
PubMed 12824994BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
PubMed 14199536Menon R, Bonney EA, Condon J, Mesiano S, Taylor RN. Novel concepts on pregnancy clocks and alarms: redundancy and synergy in human parturition. Hum Reprod Update. 2016 Sep;22(5):535-60. doi: 10.1093/humupd/dmw022. Epub 2016 Jun 30.
PubMed 27363410Torricelli M, Novembri R, Voltolini C, Conti N, Biliotti G, Piccolini E, Cevenini G, Smith R, Petraglia F. Biochemical and biophysical predictors of the response to the induction of labor in nulliparous postterm pregnancy. Am J Obstet Gynecol. 2011 Jan;204(1):39.e1-6. doi: 10.1016/j.ajog.2010.08.014. Epub 2010 Oct 8.
PubMed 20932507Funghi L, Torricelli M, Novembri R, Vannuccini S, Cevenini G, Di Tommaso M, Severi FM, Petraglia F. Placental and maternal serum activin A in spontaneous and induced labor in late-term pregnancy. J Endocrinol Invest. 2018 Feb;41(2):171-177. doi: 10.1007/s40618-017-0640-z. Epub 2017 Jun 13.
PubMed 28612286Riboni F, Garofalo G, Pascoli I, Vitulo A, Dell'avanzo M, Battagliarin G, Paternoster D. Labour induction at term: clinical, biophysical and molecular predictive factors. Arch Gynecol Obstet. 2012 Nov;286(5):1123-9. doi: 10.1007/s00404-012-2432-1. Epub 2012 Jun 24.
PubMed 22729138Menon R, Moore JJ. Fetal Membranes, Not a Mere Appendage of the Placenta, but a Critical Part of the Fetal-Maternal Interface Controlling Parturition. Obstet Gynecol Clin North Am. 2020 Mar;47(1):147-162. doi: 10.1016/j.ogc.2019.10.004. Epub 2019 Dec 18.
PubMed 32008665Marcellin L, Schmitz T, Messaoudene M, Chader D, Parizot C, Jacques S, Delaire J, Gogusev J, Schmitt A, Lesaffre C, Breuiller-Fouche M, Caignard A, Vaiman D, Goffinet F, Cabrol D, Gorochov G, Mehats C. Immune Modifications in Fetal Membranes Overlying the Cervix Precede Parturition in Humans. J Immunol. 2017 Feb 1;198(3):1345-1356. doi: 10.4049/jimmunol.1601482. Epub 2016 Dec 28.
PubMed 28031337
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomarkers in Term Labor Induction in Low-Risk Nulliparous Patients: Toward Better Prediction of Induction Outcomes
- ClinicalTrials.gov ID
- NCT07637318
- Acronym / sponsor ID
- PREDISS / APHP251724
- Keywords
- Pregnancy, Childbirth, Induction of labor, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Jun 2026 (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.
Labor induction rates are increasing worldwide, yet nulliparous patients remain at high risk of failed induction and intrapartum cesarean delivery as well as prolonged labor which are associated with increased maternal morbidity, adverse outcomes in future pregnancies, increased neonatal morbidity and negative childbirth experience. This study aims to evaluate whether macrophage activation biomarkers in cervicovaginal secretions can predict successful labor induction in low-risk nulliparous women at term with an unfavorable cervix (Bishop score <6).
The study focuses on three patented biomarkers of "imminence of delivery" (MCP1, CD14, and CD163), previously shown to be markedly elevated during spontaneous labor. We hypothesize that higher biomarker concentrations reflect biological readiness for labor and are associated with successful induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm). Secondary objectives include evaluating the association between biomarker concentrations and labor progression. Identifying reliable predictive biomarkers could improve patient selection for induction and optimize obstetrical management in nulliparous women.
Detailed description
The aim of labor induction is to reduce maternal and/or fetal complications associated with continuation of pregnancy while enabling vaginal delivery.
The investigators hypothesize that, at the time of induction, some key biological changes may already have occurred, thereby facilitating the initiation and progression of labor.
Our objective is to evaluate the association between the concentration of three macrophage activation biomarkers (referred to as "imminence of delivery" biomarkers) in cervicovaginal secretions (MCP1, CD14, and CD163) and successful labor induction among low-risk nulliparous women with an unfavorable cervix (Bishop score <6) at ≥39 weeks of gestation. We hypothesize that high biomarker concentrations will predict successful induction.
Pregnant women ≥ 39 weeks of gestation admitted to the maternity unit for labor induction who are eligible for the study will be approached to participate. The study procedures will be explained by the clinician (obstetrician-gynaecologist or midwife) in charge of the patient. In the absence of objection, the clinician who provided the information will complete the non-opposition form required for the patient's inclusion in the study. A cervicovaginal swab for biomarker measurement will be collected prior to labor induction.
A non-parametric Kruskal-Wallis test will be used to compare biomarker concentrations between patients who underwent caesarean delivery before 6 cm of cervical dilation and those whose labor progressed beyond 6 cm. The predictive value of biomarkers for induction success will be assessed using receiver operating characteristic (ROC) curves. The area under the curve (AUC) will be calculated with its 95% confidence interval, and the optimal threshold for each biomarker will be determined.
The predictive value of the three biomarkers will be assessed in the same manner for the following secondary outcomes: the rate of vaginal delivery within 24 hours of induction onset, the time from induction onset to delivery, and the time from induction onset to reaching 6 cm of cervical dilation.
In addition, patients will be offered the option of donating a sample of the placenta and fetal membranes (amniotic sac) following delivery. These tissues, which are not routinely preserved, will be analyzed with the aim of identifying potential new biomarkers of interest. The collection of a placental sample at delivery is not a prerequisite for participation in the study. Patients will be free to participate in the study (i.e. biomarker measurement in vaginal secretions) while objecting to the collection of a placental sample at delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nulliparous patients | – | Biological: Vaginal sampleIn low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nulliparous patients
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Singleton pregnancy
- Gestational age ≥ 39 weeks
- Nulliparous
- Live foetus
Key exclusion criteria (4 listed)
- A minor or a protected adult (under guardianship or conservatorship)
- Individuals who don't speak French or are not accompanied by a third party who speaks French
- Suspected intrauterine fetal growth restriction (estimated fetal weight < 3rd percentile or < 10th percentile with abnormal fetal Doppler)
- Presence of fetal malformations and/or genetic or chromosomal abnormalities
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 |
|---|---|---|
| Vaginal sampleA vaginal sample will be collected from 39 weeks of gestation onward, prior to labor induction. The vaginal swab for biomarker testing will be collected at the same time as the vaginal swab for Group B streptococcus screening (which is routinely performed as part of standard care, in accordance with clinical practice guidelines). Therefore, no additional procedure is required for this research. | Biological | Nulliparous patients |
Primary outcome
The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).
Time frame: Up to 7 days
3 secondary outcomes
The rate of vaginal delivery within 24 hours of the start of induction
Time frame: Within 24hours of the start of induction
The time from the beginning of labour induction to vaginal delivery (in hours)
Time frame: From the beginning of labour induction to vaginal delivery (in hours)
The time from the beginning of labour induction to 6 cm of dilation (entry into the active phase) (in hours)
Time frame: From the beginning of labour induction to 6 cm of dilation
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 20 Jul 2026.
- Background: PubMed 31628852Blanc-Petitjean P, Schmitz T, Salome M, Goffinet F, Le Ray C; MEDIP Study Group. Target populations to reduce cesarean rates after induced labor: A national population-based cohort study. Acta Obstet Gynecol Scand. 2020 Mar;99(3):406-412. doi: 10.1111/aogs.13751. Epub 2019 Nov 19.
- Background: PubMed 25918180Norwitz ER, Bonney EA, Snegovskikh VV, Williams MA, Phillippe M, Park JS, Abrahams VM. Molecular Regulation of Parturition: The Role of the Decidual Clock. Cold Spring Harb Perspect Med. 2015 Apr 27;5(11):a023143. doi: 10.1101/cshperspect.a023143.
- Background: PubMed 33952678Stelzer IA, Ghaemi MS, Han X, Ando K, Hedou JJ, Feyaerts D, Peterson LS, Rumer KK, Tsai ES, Ganio EA, Gaudilliere DK, Tsai AS, Choisy B, Gaigne LP, Verdonk F, Jacobsen D, Gavasso S, Traber GM, Ellenberger M, Stanley N, Becker M, Culos A, Fallahzadeh R, Wong RJ, Darmstadt GL, Druzin ML, Winn VD, Gibbs RS, Ling XB, Sylvester K, Carvalho B, Snyder MP, Shaw GM, Stevenson DK, Contrepois K, Angst MS, Aghaeepour N, Gaudilliere B. Integrated trajectories of the maternal metabolome, proteome, and immunome predict labor onset. Sci Transl Med. 2021 May 5;13(592):eabd9898. doi: 10.1126/scitranslmed.abd9898.
- Background: PubMed 36429118Socha MW, Flis W, Pietrus M, Wartega M, Stankiewicz M. Signaling Pathways Regulating Human Cervical Ripening in Preterm and Term Delivery. Cells. 2022 Nov 21;11(22):3690. doi: 10.3390/cells11223690.
- Background: PubMed 36723449Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2021. Natl Vital Stat Rep. 2023 Jan;72(1):1-53.
- Background: PubMed 30089070Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
- Background: PubMed 25412695Le Ray C, Blondel B, Prunet C, Khireddine I, Deneux-Tharaux C, Goffinet F. Stabilising the caesarean rate: which target population? BJOG. 2015 Apr;122(5):690-9. doi: 10.1111/1471-0528.13199. Epub 2014 Nov 21.
- Background: PubMed 12824994Johnson DP, Davis NR, Brown AJ. Risk of cesarean delivery after induction at term in nulliparous women with an unfavorable cervix. Am J Obstet Gynecol. 2003 Jun;188(6):1565-9; discussion 1569-72. doi: 10.1067/mob.2003.458.
- Background: PubMed 14199536BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
- Background: PubMed 27363410Menon R, Bonney EA, Condon J, Mesiano S, Taylor RN. Novel concepts on pregnancy clocks and alarms: redundancy and synergy in human parturition. Hum Reprod Update. 2016 Sep;22(5):535-60. doi: 10.1093/humupd/dmw022. Epub 2016 Jun 30.
- Background: PubMed 20932507Torricelli M, Novembri R, Voltolini C, Conti N, Biliotti G, Piccolini E, Cevenini G, Smith R, Petraglia F. Biochemical and biophysical predictors of the response to the induction of labor in nulliparous postterm pregnancy. Am J Obstet Gynecol. 2011 Jan;204(1):39.e1-6. doi: 10.1016/j.ajog.2010.08.014. Epub 2010 Oct 8.
- Background: PubMed 28612286Funghi L, Torricelli M, Novembri R, Vannuccini S, Cevenini G, Di Tommaso M, Severi FM, Petraglia F. Placental and maternal serum activin A in spontaneous and induced labor in late-term pregnancy. J Endocrinol Invest. 2018 Feb;41(2):171-177. doi: 10.1007/s40618-017-0640-z. Epub 2017 Jun 13.
- 6\. Camille Le Ray, Lelong N, Demiguel V. Enquête Nationale Périnatale - Rapport 2021.Link provided by the sponsor.
- Méhats Céline. COMBINAISON DE BIOMARQUEURS D'ADMINISTRATION À VENIR \[Internet\]. 2022Link provided by the sponsor.
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.
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 Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 4 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 20 Jul 2026. 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 France. 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?
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?
Contact Maëlys NKOBETCHOU, Medical Degree (01 58 41 38 18 ext. +33, maelys.nkobetchou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm). (time frame: Up to 7 days). 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 NCT07637318, which also lists 15 linked publications.
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 20 Jul 2026.