E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cervix ripening
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maturation cervicale |
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E.1.1.1 | Medical condition in easily understood language |
cervix ripening |
maturation cervicale |
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E.1.1.2 | Therapeutic area | Body processes [G] - Biological Phenomena [G16] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10073175 |
E.1.2 | Term | Induction of cervix ripening |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Demonstrate, if cervical ripening failure by a first Propess®, the laying of a second Propess® (followed if necessary by oxytocin (Syntocinon®)) increases the rate of births vaginally by compared to the direct injection of oxytocin (Syntocinon®). |
L’objectif principal de ce travail est de démontrer, en cas d’échec de maturation cervicale par un premier Propess®, que la pose d’un deuxième Propess® (suivi si nécessaire d’ocytocine (Syntocinon®)) permet d’augmenter le taux d’accouchements par voie basse par rapport à l’injection directe d’Ocytocine (Syntocinon®). |
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E.2.2 | Secondary objectives of the trial |
1. Comparison of the proportion trigger failure
2. Assessment and comparison of maternal morbidity and mortality
3. Assessment and comparison of fetal morbidity and mortality |
1.La comparaison de la proportion d’échec de déclenchement
2. L’évaluation et comparaison de la morbimortalité maternelle
3. L’évaluation et comparaison de la morbimortalité fœtale
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 18 years.
- Term pregnancy> 37 weeks
- Current Trigger 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), one hour before inclusion
- Intact membranes
- Affiliated with the French social security system
- Having signed the consent form. |
- Patiente âgée d’au moins 18 ans.
- Grossesse à terme > 37 SA
- Déclenchement en cours, sur indication médicale
- Patientes ayant déjà eu la mise en place d’un premier Propess®, dans un délai de 24 à 36 heures (avant la signature du consentement)
- Présentation céphalique
- Conditions cervicales défavorables (score de Bishop<6), 1 heure avant l’inclusion
- Membranes intactes
- Affiliée à un régime de sécurité sociale française
- Ayant signé le formulaire de consentement.
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E.4 | Principal exclusion criteria |
- Multiple pregnancy
- Uterus scar
- Contraindications to epidural anesthesia
- Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins
- Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
- Contraindications to vaginal delivery
- Premature Rupture of Membranes (PROM)
- Intra Uterine Growth retardation (IUGR) < 3rd percentile
- Macrosomia > 97th percentile
- Impaired fetal heart rate
- Fetal Death In Utéro (IUFD)
- Patient under guardianship, curatorship or safeguard justice |
- Grossesse multiple
- Utérus cicatriciel
- Contre-indications à l’anesthésie péridurale
- Contre-indications au Propess® : antécédent récent de pathologie inflammatoire pelvienne; hypersensibilité aux prostaglandines
- Contre-indications au Syntocinon® : Hypersensibilité à l’ocytocine, troubles cardiovasculaires et toxémie gravidique sévère.
- Contre-indications à l’accouchement voie basse
- Rupture Prématurée des Membranes (RPM)
- Retard de Croissance Intra Utérin (RCIU) < 3ème percentile
- Macrosomie > 97ème percentile
- Altération du rythme cardiaque fœtal
- Mort Fœtale In Utéro (MFIU)
- Patiente sous tutelle, curatelle ou sauvegarde de justice
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E.5 End points |
E.5.1 | Primary end point(s) |
The rate of vaginal deliveries. |
Le taux d’accouchements par voie basse. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the delivery |
A l'accouchement |
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E.5.2 | Secondary end point(s) |
1. The triggering of failure
The failure of the trigger is the lack of work setting: remaining cervical dilation <3cm despite 8am Syntocinon (or 1 syringe) and lack of regular uterine contractions and amniotomy. The success of the trigger is defined by regular uterine contractions and cervical dilatation ≥ 3 cm.
2. Criteria of maternal morbidity and mortality:
- Duration of work: time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilatation of ≥3 cm and childbirth.
- Caesarean indications
- Proportion of instrumental delivery
- Proportion of complications of delivery and the various supported.
- Proportion of uterine rupture
- The transfer to intensive care
- Duration of hospital stay of the mother
- maternal death
3. Criteria fetal morbidity and mortality:
- Apgar score at 3, 5 and 10 min
- Assessment of fetal acidosis umbilical arterial pH and lactate
- The presence of amniotic fluid meconium
- The share transfer in neonatology or neonatal resuscitation
- Fetal / neonatal death |
1. L’échec du déclenchement
L’échec du déclenchement correspond à l’absence de mise en travail : dilatation cervicale restant < 3cm malgré 8h de Syntocinon® (ou 1 seringue) et absence de contractions utérines régulières et d’amniotomie.
Le succès du déclenchement est défini par des contractions utérines régulières et une dilatation cervicale ≥ 3 cm.
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2. Critères de morbi-mortalité maternelle :
- Durée du travail : durée en minutes, entre le début du travail défini par la survenue de contractions utérines régulières et d’une dilatation cervicale ≥3 cm et l’accouchement.
- les indications de césarienne
- la proportion d’extraction instrumentale
- la proportion de complications de la délivrance et les différentes prises en charge.
- la proportion de rupture utérine
- le transfert en réanimation
- la durée d’hospitalisation de la maman
- le décès maternel
3. Critères de morbi-mortalité fœtale :
- score d’Apgar à 3, 5 et 10 min
- évaluation de l’acidose fœtale : pH artériel ombilical ou lactates
- présence de liquide amniotique méconial
- la proportion de transfert en néonatalogie ou réanimation néonatale
- décès fœtal / néonatal
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 24h
2. At the end of hospitalisation
3. After delivery |
1. 24h
2. A la fin de l'hospitalisation
3. Après l'accouchement |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 10 |