AzTrials
AzTrials

Cervical RipeningPhase 3RE-DINONCT02888041

Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?

A Phase 3 study testing Dinoprostone and Oxytocine in people with Cervical Ripening and Pregnancy, run by University Hospital, Limoges at 7 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

According perinatal surveys, induction of labor is performed at more than 20% of pregnant women. According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Ripening, Pregnancy
What is being tested?
Dinoprostone and Oxytocine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
7 sitesFrance
Study dates
Dec 2016to 23 Apr 2022
Phase
Phase 3
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

  • Patient who is >=18 years.
  • Term pregnancy > 37 weeks
  • Induction of labor in progress, medically indicated
  • Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
  • Cephalic presentation
  • Unfavorable cervical conditions (Bishop score <6) 1 hour prior to inclusion
Show all 9Show fewer
  • Intact Membranes
  • Affiliated with a social security system
  • Having signed the consent form.

Who cannot join

  • Multiple pregnancy
  • Uterus scar
  • Contraindications to epidural anesthesia
  • Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins Adverse effects appeared in the first Propess®: anaphylactic shock, disseminated intravascular coagulation (DIC).
  • Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
  • Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
Show all 13Show fewer
  • Premature Rupture of Membranes (PROM)
  • Intra Uterine Growth Retardation (IUGR) <3rd percentile
  • Macrosomia> 97th percentile
  • Severe Impaired fetal heart rate
  • In Utero Fetal Death (IUFD)
  • Medical Termination of pregnancy or lethal fetal pathology
  • Patient under guardianship or trusteeship safeguard justice

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CH de Blois

    Blois, 41250

  • CH de BRIVE

    Brive-la-Gaillarde, 19100

  • CH Metropole Savoie

    Chambéry, 73011

  • Hôpital d'Estaing - CHU de Clermont-Ferrand

    Clermont-Ferrand, 63100

  • CHU de LIMOGES

    Limoges, 87045

  • Hôpital Nord - APHM

    Marseille, 13015

  • CH de TULLE

    Tulle, 19012

Other trials in France

About this study

According perinatal surveys, induction of labor is performed at more than 20% of pregnant women.

According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®).

Read more

The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries.

Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses.

Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.

Being tested
Dinoprostone, Oxytocine
Keywords
Cervical ripening, Pregnancy, Vaginal Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DinoprostoneDrug

    In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10 mg), patients receive a second Propess®, followed by Oxytocin 5U.I/ml (Syntocinon®) (if necessary) and epidural analgesia if desired by the patient.

  • OxytocineDrug

    In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10mg), patients receive directly Oxytocin 5U.I/ml (Syntocinon®) and epidural analgesia if desired by the patient.

Study groups in NCT02888041
Study groupRoleWhat they receive
DinoprostoneExperimentalIn case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10 mg), patients receive a second Propess®, followed by Oxytocin 5U.I/ml (Syntocinon®) (if necessary) and epidural analgesia if desired by the patient.
Receives: Drug: Dinoprostone
OxytocineActive comparatorIn case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10mg), patients receive directly Oxytocin 5U.I/ml (Syntocinon®) and epidural analgesia if desired by the patient.
Receives: Drug: Oxytocine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of deliveries vaginally

    The rate of births vaginally in each arm

    Measured: At delivery

Secondary outcomes (14)

  1. Failure of induction of labor

    The failure of induction of labor correspond to cervical dilation remaining <3cm despite 6 hours of Syntocinon (or 1 syringe) and regular uterine contractions and amniotomy.

    The success of the trigger is defined by regular uterine contractions and cervical dilatation ≥ 3 cm.

    Measured: At delivery

  2. Time of work

    Time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilation ≥3 cm and delivery.

    Measured: delivery time

  3. Caesarean indications

    Caesarean indications

    Measured: At delivery

  4. Proportion of instrumental delivery

    The proportion of instrumental delivery

    Measured: At delivery

  5. Proportion of complications of delivery and various care.

    The proportion of complications of delivery and various care.

    Measured: Day 1

  6. Proportion of complete uterine rupture

    The proportion of complete uterine rupture

    Measured: At delivery

  7. Transfer in Intensive Care Unit

    The transfer in Intensive Care Unit

    Measured: 10 Days

  8. Maternal death

    Maternal death

    Measured: 10 Days

  9. Hospital stay of mother

    Hospital stay of mother

    Measured: 10 Days

  10. Apgar score

    Determination of Apgar score

    Measured: 3 Min, 5 Min and 10 Min

  11. Visual estimation of presence of amniotic fluid meconium

    Visual estimation of presence of meconium in amniotic fluid. Absence of meconium if transparent and presence if colored.

    Measured: At the birth

  12. Proportion of transfer neonatal or newborn intensive care unit

    The proportion of transfer neonatal or newborn intensive care unit

    Measured: At the birth

  13. Fetal / neonatal death

    Fetal / neonatal death

    Measured: At the birth

  14. Assessment of fetal acidosis by measuring of pH, lactates and base excess

    Assessment of fetal acidosis by measuring of pH, lactates and base excess

    Measured: At the birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion23 Apr 2022
  4. Study completion23 Apr 2022

Why it stopped: Not enough patients

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888041
Sponsor's protocol ID
I15014 (RE-DINO)
Acronym
RE-DINO
Status last verified
Aug 2024
First submitted
24 Aug 2016
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Coste Mazeau P, Hessas M, Martin R, Eyraud JL, Margueritte F, Aubard Y, Sallee C, Sire F, Gauthier T. Is there an interest in repeating the vaginal administration of dinoprostone (Propess(R)), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial. Trials. 2020 Jan 8;21(1):51. doi: 10.1186/s13063-019-3985-0.

    PubMed 31915047

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dinoprostone and Oxytocine in people with Cervical Ripening and Pregnancy, run by University Hospital, Limoges at 7 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Not enough patients). Results are not available in the source record.

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?

Rate of deliveries vaginally (time frame: At delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02888041, which also lists 1 linked publication.

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 28 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in