Prediction of Labor Induction Outcome in Nulliparous Women

NCT07637318 | Not Yet Recruiting

• 1 other identifier: APHP251724
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Nulliparous Patient With Unfavourable Cervix, Undergoing Labor Induction at Term ≥ 39SA

Keywords

Pregnancy; Childbirth; Induction of labor; Biomarkers

Outcome Measures

Primary Outcomes (1)

• The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).

  1 Day

Secondary Outcomes (3)

• The association between the concentration of the three biomarkers and the rate of vaginal delivery within 24 hours of the start of induction

  1 day

• The association between the concentration of the three biomarkers and the time from the beginning of labour induction to vaginal delivery (in hours)

  1 day

• The association between the concentration of the three biomarkers and the time from the beginning of labour induction to 6 cm of dilation (entry into the active phase) (in hours)

  1 day

Study Arms (1)

Nulliparous patients

In low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA

Biological: Vaginal sample

Interventions

Vaginal sample BIOLOGICAL

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.

Nulliparous patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous patients

You may qualify if:

• Age ≥ 18 years
• Singleton pregnancy
• Gestational age ≥ 39 weeks
• Nulliparous
• Live foetus
• Cephalic presentation
• Intact membranes
• Bishop score \< 6
• Willing to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

AP-HP - Hôpital Cochin - Maternité Port-Royal

Paris, Île-de-France Region, 75014, France

Location

Related Publications (15)

• 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.

  PMID: 31628852 BACKGROUND

• Norwitz 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.

  PMID: 25918180 BACKGROUND

• Stelzer 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.

  PMID: 33952678 BACKGROUND

• Socha 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.

  PMID: 36429118 BACKGROUND

• Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2021. Natl Vital Stat Rep. 2023 Jan;72(1):1-53.

  PMID: 36723449 BACKGROUND

• Grobman 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.

  PMID: 30089070 BACKGROUND

• Le 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.

  PMID: 25412695 BACKGROUND

• Johnson 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.

  PMID: 12824994 BACKGROUND

• BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

  PMID: 14199536 BACKGROUND

• Menon 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.

  PMID: 27363410 BACKGROUND

• Torricelli 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.

  PMID: 20932507 BACKGROUND

• Funghi 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.

  PMID: 28612286 BACKGROUND

• Riboni 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.

  PMID: 22729138 BACKGROUND

• Menon 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.

  PMID: 32008665 BACKGROUND

• Marcellin 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.

  PMID: 28031337 BACKGROUND

Related Links

• 6\. Camille Le Ray, Lelong N, Demiguel V. Enquête Nationale Périnatale - Rapport 2021.
• Méhats Céline. COMBINAISON DE BIOMARQUEURS D'ADMINISTRATION À VENIR \[Internet\]. 2022

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervicovaginal samples and placenta samples

Central Study Contacts

Maëlys NKOBETCHOU, Medical Degree

CONTACT

01 58 41 38 18; maelys.nkobetchou@aphp.fr

Christelle AUGER

CONTACT

01 71 76 07 53; christelle.auger@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

FR (1)