Prediction of Spontaneous Onset of Labor at Term

NCT05109247 | Completed

• 1 other identifier: 19-261
• Study Type: observational
• Target: 429
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks

Secondary Outcomes (2)

• Gestational age at spontaneous onset of labor

  2 weeks

• Gestational age at spontaneous onset of labor

  1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Hologic, Inc.: collaborator
• QIAGEN Gaithersburg, Inc: collaborator
• Pregnolia AC: collaborator

Study Sites (3)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35830435 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician, Principal Investigator

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: August 22, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CH (3)