Prediction of Spontaneous Onset of Labor at Term

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor, Induced Labor Onset Labor, Obstetric Predictive Model

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois, Lausanne, Canton of Vaud, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Spontaneous versus induced onset of labor

Time frame: 3 weeks

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

Secondary outcomes

Gestational age at spontaneous onset of labor

Time frame: 2 weeks

Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor
Gestational age at spontaneous onset of labor

Time frame: 1 week

Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

Hologic, Inc.
Pregnolia AC
QIAGEN Gaithersburg, Inc

Registry information

Acronym: PREDICT

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Nov 5, 2021
Registry last updated: Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting