Medical; Abortion, Fetus
Conditions
Brief summary
Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.
Interventions
PROCEDUREMifepristone + Misoprostol OR oxytocine
standart support
PROCEDUREMifepristone + Misoprostol OR oxytocine + laminaria
Three laminaria placed 12 hours prior to administration of misoprostol
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The primary outcome will be evaluated by a blinded evaluator: the laminaria placement is performed by the on-call team at Day-1, whilst the delivery is performed by a different team at Day 0, with the laminaria removed in the morning.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patients is at least 18 years old * Patient with a singleton pregnancy between 14 and 34 weeks gestation with an indication for medical termination due to maternal or fetal problem as validated by pluridisciplinary prenatal diagnosis center.
Exclusion criteria
* The subject is participating in an interventional study or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice * The subject refuses to sign the consent * It is impossible to give the subject informed information * Patient has vaginismus * Patient has a cervix permitting artificial rupture of membrane * Patients taking one of the following treatments, contraindicated for mifepristone: ketoconazole, itraconazole, erythromycin, grapefruit juice, rifampicin, dexamethasone, St John's wort and certain anti-convulsants (phenytoin, phenobarbital, carbamazepine). Patients contraindicated for oxytocine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time taken between administration of 1st dose of drugs and delivery between the two strategies | Up to 2 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare cervix length before administration of Misoprostol OR oxytocine between groups | Day 0 | in mm |
| Compare degree of dilation before administration of Misoprostol OR oxytocine between groups | Day 0 | in cm |
| Compare time taken between Misoprostol OR oxytocine and delivery between groups | Day 0 - Day 2 | hours |
| Rate of delivery between groups | 4 hours | — |
| Compare pain experienced by patients between groups | Day 0 - Day 2 | scale 0-10 |
| Incidence of hemorrhage between groups | Day 0 - Day 2 | — |
| Patient satisfaction in peripartum between groups | Day 2 | Numeric Rating Scale (0-10) |
| Patient anxiety between groups | Day 0 - 3 months | Hospital Anxiety and Depression Scale questionnaire |
| Evaluation of any post-traumatic stress between groups | 3 months | Perinatal post-traumatic stress disorder questionnaire |
| Incidence of endometritis between groups | Day 0 - Day 2 | — |
Countries
France
Outcome results
None listed