Medical; Abortion, Fetus Clinical Trial
— IMEGYNOfficial title:
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
Verified date | October 2023 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 25, 2023 |
Est. primary completion date | September 25, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Montpellier | Montpellier | |
France | CHU Nimes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time taken between administration of 1st dose of drugs and delivery between the two strategies | Up to 2 days | ||
Secondary | Compare pain experienced by patients between groups | scale 0-10 | Day 0 - Day 2 | |
Secondary | Compare cervix length before administration of Misoprostol OR oxytocine between groups | in mm | Day 0 | |
Secondary | Compare degree of dilation before administration of Misoprostol OR oxytocine between groups | in cm | Day 0 | |
Secondary | Compare time taken between Misoprostol OR oxytocine and delivery between groups | hours | Day 0 - Day 2 | |
Secondary | Rate of delivery between groups | 4 hours | ||
Secondary | Rate of delivery between groups | 6 hours | ||
Secondary | Rate of delivery between groups | 8 hours | ||
Secondary | Rate of delivery between groups | 12 hours | ||
Secondary | Rate of delivery between groups | >12 hours | ||
Secondary | Incidence of endometritis between groups | Day 0 - Day 2 | ||
Secondary | Incidence of hemorrhage between groups | Day 0 - Day 2 | ||
Secondary | Patient satisfaction in peripartum between groups | Numeric Rating Scale (0-10) | Day 2 | |
Secondary | Patient anxiety between groups | Hospital Anxiety and Depression Scale questionnaire | Day 0 - 3 months | |
Secondary | Evaluation of any post-traumatic stress between groups | Perinatal post-traumatic stress disorder questionnaire | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02694198 -
Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion
|
N/A | |
Completed |
NCT01860521 -
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
|
N/A | |
Withdrawn |
NCT04304365 -
Home Follow-up After Medication Abortion
|
N/A | |
Completed |
NCT03400358 -
Uterocervical Angle in the Pregnancy Termination of Multiparous Women
|
N/A | |
Recruiting |
NCT05342467 -
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
|
Phase 2 | |
Recruiting |
NCT03269279 -
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
|
Phase 3 | |
Completed |
NCT02381223 -
Simplified Medical Abortion Screening: A Pilot Demonstration Project
|
N/A | |
Recruiting |
NCT05940233 -
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
|
N/A | |
Not yet recruiting |
NCT03570307 -
Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage First-trimester Miscarriage
|
N/A | |
Completed |
NCT01943279 -
Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion
|
N/A | |
Not yet recruiting |
NCT04194658 -
Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion
|
Phase 2 | |
Completed |
NCT01966874 -
Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation
|
Phase 2/Phase 3 |