Prediction of Spontaneous Onset of Labor at Term

Labor, Induced Clinical Trial

— PREDICT  

Official title:

Prediction of Spontaneous Onset of Labor at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109247
• Other study ID #: 19-261
• Status: Completed
• Start date: August 22, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor Onset
• Labor, Induced
• Labor, Obstetric
• Predictive Model

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Geneva	Hologic, Inc., Pregnolia AC, QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gestational age at spontaneous onset of labor	Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor	2 weeks
Secondary	Gestational age at spontaneous onset of labor	Time from sample collection at 40 weeks of pregnancy to spontaneous onset of labor	1 week