Medical; Abortion, FetusIMEGYNNCT03194126
Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination
A study testing Mifepristone + Misoprostol OR oxytocine + laminaria and Mifepristone + Misoprostol OR oxytocine in people with Medical; Abortion, Fetus, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical; Abortion, Fetus
- What is being tested?
- Mifepristone + Misoprostol OR oxytocine + laminaria and Mifepristone + Misoprostol OR oxytocine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Feb 2018to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
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.
- Conditions
- Medical; Abortion, Fetus
- Being tested
- Mifepristone + Misoprostol OR oxytocine + laminaria, Mifepristone + Misoprostol OR oxytocine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone + Misoprostol OR oxytocine + laminariaProcedure or surgery
Three laminaria placed 12 hours prior to administration of misoprostol
Mifepristone + Misoprostol OR oxytocineProcedure or surgery
standart support
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone + Misoprostol OR oxytocine + laminaria | Experimental | Not described Receives: Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria |
| Mifepristone + Misoprostol OR oxytocine | Other | Not described Receives: Procedure: Mifepristone + Misoprostol OR oxytocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time taken between administration of 1st dose of drugs and delivery between the two strategies
Measured: Up to 2 days
Secondary outcomes (14)
Compare pain experienced by patients between groups
scale 0-10
Measured: Day 0 - Day 2
Compare cervix length before administration of Misoprostol OR oxytocine between groups
in mm
Measured: Day 0
Compare degree of dilation before administration of Misoprostol OR oxytocine between groups
in cm
Measured: Day 0
Compare time taken between Misoprostol OR oxytocine and delivery between groups
hours
Measured: Day 0 - Day 2
Rate of delivery between groups
Measured: 4 hours
Rate of delivery between groups
Measured: 6 hours
Rate of delivery between groups
Measured: 8 hours
Rate of delivery between groups
Measured: 12 hours
Rate of delivery between groups
Measured: >12 hours
Incidence of endometritis between groups
Measured: Day 0 - Day 2
Incidence of hemorrhage between groups
Measured: Day 0 - Day 2
Patient satisfaction in peripartum between groups
Numeric Rating Scale (0-10)
Measured: Day 2
Patient anxiety between groups
Hospital Anxiety and Depression Scale questionnaire
Measured: Day 0 - 3 months
Evaluation of any post-traumatic stress between groups
Perinatal post-traumatic stress disorder questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start11 Feb 2018
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194126
- Sponsor's protocol ID
- LOCAL/2016/VL-01
- Acronym
- IMEGYN
- Status last verified
- Oct 2023
- First submitted
- 16 Jun 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone
- ClinicalTrials.gov ID
- NCT03194126
- Acronym / sponsor ID
- IMEGYN / LOCAL/2016/VL-01
- Conditions
- Medical; Abortion, Fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Feb 2018 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone + Misoprostol OR oxytocine + laminaria | Experimental | Procedure: Mifepristone + Misoprostol OR oxytocine + laminaria |
| Mifepristone + Misoprostol OR oxytocine | Other | Procedure: Mifepristone + Misoprostol OR oxytocine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone + Misoprostol OR oxytocine + laminariaThree laminaria placed 12 hours prior to administration of misoprostol | Procedure or surgery | Mifepristone + Misoprostol OR oxytocine + laminaria |
| Mifepristone + Misoprostol OR oxytocinestandart support | Procedure or surgery | Mifepristone + Misoprostol OR oxytocine |
Primary outcome
time taken between administration of 1st dose of drugs and delivery between the two strategies
Time frame: Up to 2 days
14 secondary outcomes
Compare pain experienced by patients between groups
Time frame: Day 0 - Day 2
Compare cervix length before administration of Misoprostol OR oxytocine between groups
Time frame: Day 0
Compare degree of dilation before administration of Misoprostol OR oxytocine between groups
Time frame: Day 0
Compare time taken between Misoprostol OR oxytocine and delivery between groups
Time frame: Day 0 - Day 2
Rate of delivery between groups
Time frame: 4 hours
Rate of delivery between groups
Time frame: 6 hours
Rate of delivery between groups
Time frame: 8 hours
Rate of delivery between groups
Time frame: 12 hours
Rate of delivery between groups
Time frame: >12 hours
Incidence of endometritis between groups
Time frame: Day 0 - Day 2
Incidence of hemorrhage between groups
Time frame: Day 0 - Day 2
Patient satisfaction in peripartum between groups
Time frame: Day 2
Patient anxiety between groups
Time frame: Day 0 - 3 months
Evaluation of any post-traumatic stress between groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone + Misoprostol OR oxytocine + laminaria and Mifepristone + Misoprostol OR oxytocine in people with Medical; Abortion, Fetus, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time taken between administration of 1st dose of drugs and delivery between the two strategies (time frame: Up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.