Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone

Conditions
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Medical; Abortion, Fetus

Intervention / Treatment
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* Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria
* Procedure: Mifepristone + Misoprostol OR oxytocine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone + Misoprostol OR oxytocine + laminaria<br> | Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria<br>* Three laminaria placed 12 hours prior to administration of misoprostol<br>|
| Other: Mifepristone + Misoprostol OR oxytocine<br> | Procedure: Mifepristone + Misoprostol OR oxytocine<br>* standart support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time taken between administration of 1st dose of drugs and delivery between the two strategies |  | Up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pain experienced by patients between groups | scale 0-10 | Day 0 - Day 2 | 
| Compare cervix length before administration of Misoprostol OR oxytocine between groups | in mm | Day 0 | 
| Compare degree of dilation before administration of Misoprostol OR oxytocine between groups | in cm | Day 0 | 
| Compare time taken between Misoprostol OR oxytocine and delivery between groups | hours | Day 0 - Day 2 | 
| Rate of delivery between groups |  | 4 hours | 
| Rate of delivery between groups |  | 6 hours | 
| Rate of delivery between groups |  | 8 hours | 
| Rate of delivery between groups |  | 12 hours | 
| Rate of delivery between groups |  | >12 hours | 
| Incidence of endometritis between groups |  | Day 0 - Day 2 | 
| Incidence of hemorrhage between groups |  | Day 0 - Day 2 | 
| Patient satisfaction in peripartum between groups | Numeric Rating Scale (0-10) | Day 2 | 
| Patient anxiety between groups | Hospital Anxiety and Depression Scale questionnaire | Day 0 - 3 months | 
| Evaluation of any post-traumatic stress between groups | Perinatal post-traumatic stress disorder questionnaire | 3 months |