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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone + Misoprostol OR oxytocine + laminaria | Experimental |
| |
| Mifepristone + Misoprostol OR oxytocine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone + Misoprostol OR oxytocine + laminaria | Procedure | Three laminaria placed 12 hours prior to administration of misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| time taken between administration of 1st dose of drugs and delivery between the two strategies | Up to 2 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients contraindicated for oxytocine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | 34295 | France | |||
| CHU Nimes |
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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.
| Mifepristone + Misoprostol OR oxytocine | Procedure | standart support |
|
| 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 |
| Nîmes |
| 30029 |
| France |
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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