Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Cervical hardness score
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cervical hardness score
Time Frame: Day 0 (baseline)
A score varying from 0 to 10 determined during cervical ultrasound with elastography.
Mode of delivery: vaginal delivery versus cesarean
Time Frame: Day 2
Secondary Outcomes
- Induction mode(Day 0 (baseline))
- Cervical hardness score for reproductibility 1(Day 0 (baseline))
- Bishop score(Day 0 (baseline))
- Parity(Day 0 (baseline))
- Time lapsed between labor induction and delivery(Day 2)
- Cervical hardness score for reproductibility 2(Day 0 (baseline))
- Cost of hospital stay(Expected average of 4-5 days)