Prediction of Spontaneous Onset of Labor at Term

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05109247

Acronym

PREDICT

Enrollment

429

Registered

2021-11-05

Start date

2019-08-22

Completion date

2022-12-31

Last updated

2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Spontaneous versus induced onset of labor	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

Measure	Time frame	Description
Gestational age at spontaneous onset of labor	2 weeks	Time from sample collection at 39 weeks of pregnancy to spontaneous onset of labor

Countries

Switzerland

Outcome results