E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens |
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E.1.1.1 | Medical condition in easily understood language |
To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 |
To compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on the rate of caesarean sections in obese patients with spontaneous onset of labour |
Comparer les taux de césarienne chez les patients obèses avec travail spontané entre deux posologiques d'ocytocine |
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E.2.2 | Secondary objectives of the trial |
a. To compare the effect of higher doses of oxytocin (intervention group) vs standard doses of oxytocin (control group) on: •Maternal and labour complications: - Length of labour - Arrest of labour-Interruption of oxytocin perfusion and reason- Uterine hyper-stimulation- Mode of vaginal delivery - Reason for caesarean section- Post-partum haemorrhage- Maternal blood transfusion - Volume of oxytocin infusion- Oxytocin side effects•Foetal complications •Neonatal complications b. To create a biobank of maternal and cord blood.This bank will be used for an ancillary study part of the SENEC project which has been recently created as a FHU. The SENEC project aims at developing a multidisciplinary approach common to chronic diseases (red blood-cell, neurodegenerative, lung, cardiovascular & metabolic including obesity)
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Comparez les deux posologies d'ocytocine concernant: - Circonstances de travail et d'accouchement - Complications maternelles - Complications foetales - Complications néonatales - Effets secondaires de l'ocytocine
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A 22.5 mL blood sample will be taken during the work for the biological collection of the auxiliary project SENEC in order to conserve maternal plasma, serum and DNA. The SENEC project aims to develop a common multidisciplinary approach to chronic diseases (such as neurodegenerative, pulmonary, cardiovascular and metabolic diseases, including obesity). |
Un prélèvement sanguin de 22.5 mL sera effectué pendant le travail pour la collection biologique du projet auxiliaireSENEC afin de conserver du plasma maternel, du sérum et de l'ADN. Le projet SENEC vise à développer une approche multidisciplinaire commune aux maladies chroniques (telles que les maladies neurodégénératives, pulmonaires, cardiovasculaires et métaboliques, y compris l'obésité).
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E.3 | Principal inclusion criteria |
- Age ≥ 18 years - Nulliparous - Singleton pregnancy - Obesity defined as BMI ≥ 30 kg/m2 (during first trimester of pregnancy) - Spontaneous onset of labour - Cephalic presentation - Term ≥ 37 weeks of gestation and < 42 weeks of gestation - Medical indication and absence of medical contraindication for oxytocin during labour: inadequate and/or ineffective uterine contraction and/or delayed cervical dilation - Written consent - Affiliation to a french social security system
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Âge ≥ 18 ans - Nullipare - Grossesse singleton - Obésité définie par un IMC ≥ 30 kg / m2 (au cours du premier trimestre de la grossesse) - Début spontané du travail - Présentation céphalique - Terme ≥ 37 semaines de gestation et <42 semaines de gestation - Indication médicale et absence de contre-indication médicale à l'ocytocine pendant le travail: contraction utérine insuffisante et / ou inefficace et / ou dilatation cervicale retardée - Consentement écrit - Affiliation à un système de sécurité sociale français
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E.4 | Principal exclusion criteria |
- Hypersensitivity to the active substance (oxytocin) or to any of its excipients - Medical contraindication for oxytocin - Coagulation disorders - Foetal growth restriction (inferior to 5th percentile) - Foetal malformation - Foetal heart rate anomalies before use of oxytocin - History of uterine surgery - Patient with a disease requiring induction of labour or caesarean section prior to labour - Curatorship or guardianship - Participation in another interventional trial |
Hypersensibilité à la substance active (ocytocine) ou à l'un de ses excipients - Contre-indication médicale à l'ocytocine - Troubles de la coagulation - Restriction de croissance fœtale (inférieure au 5e percentile) - Malformation fœtale - Anomalies de la fréquence cardiaque fœtale avant l'utilisation de l'ocytocine - Histoire de la chirurgie utérine - Patient avec une maladie nécessitant le déclenchement du travail ou une césarienne avant le travail - Curatelle ou tutelle - Participation à une autre recherche interventionnelle
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the rates of caesarean section in obese patients with spontaneous labour between two oxytocin dosage regimens |
Comparer les taux de césarienne chez les patients obèses avec travail spontané entre deux posologiques d'ocytocine |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of follow-up for the last patient |
fin de suivi de la dérniere patiente |
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E.5.2 | Secondary end point(s) |
Compare the two oxytocin dosage regimens for: - Labour and delivery circumstances - Maternal complications - Foetal complications - Neonatal complications - Oxytocin side effects
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Comparez les deux posologies d'ocytocine concernant: - Circonstances de travail et d'accouchement - Complications maternelles - Complications foetales - Complications néonatales - Effets secondaires de l'ocytocine
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of follow-up for the last patient |
At the end of follow-up for the last patient |
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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 | Yes |
E.6.3 | Therapy | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Compare the two oxytocin dosage |
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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 | 14 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 25 |
E.8.9.1 | In the Member State concerned days | |