Prediction of Spontaneous Onset of Labor at Term

NCT ID: NCT05109247

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2022-12-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Alive fetus
• Singletons
• Cephalic presentation
• Intact membranes
• Gestational age ≥ 38 weeks and 5 days

Exclusion Criteria

• 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
• Language barrier
• Inability to give consent

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role: collaborator

Pregnolia AC

UNKNOWN

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Federico Migliorelli

Obstetrician, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Universitätsspital Basel

Basel, , Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35830435 (View on PubMed)

Other Identifiers

19-261

Identifier Type: -

Identifier Source: org_study_id