Clinical trial NCT02373800: Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
Official title: Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Labor, Induced
Keywords: Induced
pre-term labor
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center.

Brief summary: The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).

Detailed description: The secondary objectives of this study are:

A. To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode.

B. To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score \< 6).

C. To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone.

D. To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography.

E. To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.

Eligibility criteria: Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Pregnant woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation.

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* History of cervical surgery
* Malformation of the cervix

Primary outcomes:
measure: Cervical hardness score
timeFrame: Day 0 (baseline)
measure: Mode of delivery: vaginal delivery versus cesarean
timeFrame: Day 2
Secondary outcomes:
measure: Bishop score
timeFrame: Day 0 (baseline)
measure: Parity
timeFrame: Day 0 (baseline)
measure: Time lapsed between labor induction and delivery
timeFrame: Day 2
measure: Induction mode
timeFrame: Day 0 (baseline)
measure: Cervical hardness score for reproductibility 1
timeFrame: Day 0 (baseline)
measure: Cervical hardness score for reproductibility 2
timeFrame: Day 0 (baseline)
measure: Cost of hospital stay
timeFrame: Expected average of 4-5 days
Other outcomes:
measure: Age in years
timeFrame: Day 0 (baseline)
measure: Body mass index
timeFrame: Day 0 (baseline)
measure: Number of previous vaginal deliveries
timeFrame: Day 0 (baseline)
measure: Duration of labor
timeFrame: Day 2
measure: Birthweight of the newborn
timeFrame: Day 2
measure: Maternal complications
timeFrame: Day 2
measure: Complications for the newborn
timeFrame: Day 2
measure: Indication for cesarian: fetal cause, cervical cause, non descent
timeFrame: Day 2
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: