Prediction of Labor Induction Outcome in Nulliparous Women (PREDISS)
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Christelle AUGER
- Номер телефона: +33 01 71 76 07 53
- Электронная почта: christelle.auger@aphp.fr
Учебное резервное копирование контактов
- Имя: Maëlys NKOBETCHOU, Medical Degree
- Номер телефона: +33 01 58 41 38 18
- Электронная почта: maelys.nkobetchou@aphp.fr
Места учебы
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Île-de-France Region
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Paris, Île-de-France Region, Франция, 75014
- AP-HP - Hôpital Cochin - Maternité Port-Royal
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 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
Exclusion Criteria
- 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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Nulliparous patients
In low-risk nulliparous patients with unfavourable cervix undergoing labor induction ≥39SA
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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The primary outcome is successful labor induction, defined as entry into the active phase of labor (cervical dilation ≥6 cm).
Временное ограничение: Up to 7 days
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Up to 7 days
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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The rate of vaginal delivery within 24 hours of the start of induction
Временное ограничение: Within 24hours of the start of induction
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Within 24hours of the start of induction
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The time from the beginning of labour induction to vaginal delivery (in hours)
Временное ограничение: From the beginning of labour induction to vaginal delivery (in hours)
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From the beginning of labour induction to vaginal delivery (in hours)
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The time from the beginning of labour induction to 6 cm of dilation (entry into the active phase) (in hours)
Временное ограничение: From the beginning of labour induction to 6 cm of dilation
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From the beginning of labour induction to 6 cm of dilation
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
- BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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):10.1101/cshperspect.a023143 a023143. doi: 10.1101/cshperspect.a023143.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- APHP251724
- IDRCB (Другой идентификатор: 2025-A02589-40)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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