Prediction of Spontaneous Onset of Labor at Term (PREDICT)

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.

Study Overview

• Status: Completed
• Conditions: Labor Onset; Labor, Induced; Labor, Obstetric; Predictive Model

• Study Type: Observational
• Enrollment (Actual): 429

Contacts and Locations

• Study Contact: Name: Federico E Migliorelli, MD, PhD; Phone Number: +34 607 31 32 57; Email: Federico.Migliorelli@hcuge.ch
• Study Contact Backup: Name: Begoña Martinez de Tejada, MD, PhD; Phone Number: +41 22 372 64 79; Email: Begona.MartinezDeTejada@hcuge.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel
  • Geneva, Switzerland, 1211
    • Hôpitaux universitaires de Genève
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at spontaneous onset of labor	Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor	2 weeks
Gestational age at spontaneous onset of labor	Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor	1 week

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: QIAGEN Gaithersburg, Inc; Hologic, Inc.; Pregnolia AC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No