Clinical trial • Not applicable • Other

Oxytocin for Induction of labour (unfavourable cervix)

Not applicable trial of Oxytocin for Induction of labour (unfavourable cervix).

Overview

Trial Therapeutic Area
Other
Trial Disease
Induction of labour (unfavourable cervix)
Trial Stage
Not applicable
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
04-10-2024
First CTIS Authorization Date
10-12-2024

Trial design

Randomised, open-label, control arm: repeat cervical ripening with prostaglandins (second cervical ripening lasting a maximum of 24 hours). comparator products listed: prostine e2 2 mg/3 g vaginal gel (dinoprostone), propess 10 mg vaginal delivery system (dinoprostone), angusta 25 microgrammes tablet (misoprostol). Not applicable trial across 14 sites in France.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: repeat cervical ripening with prostaglandins (second cervical ripening lasting a maximum of 24 hours). Comparator products listed: PROSTINE E2 2 mg/3 g vaginal gel (dinoprostone), PROPESS 10 mg vaginal delivery system (dinoprostone), ANGUSTA 25 microgrammes tablet (misoprostol).
Target Sample Size
1494

Eligibility

Recruits 1494 Pregnant women are identified as a vulnerable population. Written informed consent is required (inclusion criterion: "Written informed consent"). The protocol states: "Women who will require an induction of labor with cervical ripening will be informed of the study’s objectives by midwives/physicians and all their questions will be answered... Women should be allowed to have as much time as necessary to decide whether or not they wish to participate to the study. if they agree to participate, inclusion can be made with consent signature and randomization." Participants must be ≥ 18 years old; no assent procedures are described. Exclusion includes persons under legal protection..

Vulnerable Population
Pregnant women are identified as a vulnerable population. Written informed consent is required (inclusion criterion: "Written informed consent"). The protocol states: "Women who will require an induction of labor with cervical ripening will be informed of the study’s objectives by midwives/physicians and all their questions will be answered... Women should be allowed to have as much time as necessary to decide whether or not they wish to participate to the study. if they agree to participate, inclusion can be made with consent signature and randomization." Participants must be ≥ 18 years old; no assent procedures are described. Exclusion includes persons under legal protection.

Inclusion criteria

  • {"criterion_text":"- Pregnant woman"}
  • {"criterion_text":"- ≥ 18 years old"}
  • {"criterion_text":"- With a singleton cephalic pregnancy"}
  • {"criterion_text":"- At a term ≥37+0 weeks of gestation"}
  • {"criterion_text":"- Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation)"}
  • {"criterion_text":"- With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours"}
  • {"criterion_text":"- Bishop score ≤ 6 at inclusion (unfavorable cervix)"}
  • {"criterion_text":"- Written informed consent"}
  • {"criterion_text":"- French health insurance policy holder"}

Exclusion criteria

  • {"criterion_text":"- Any measures of legal protection"}
  • {"criterion_text":"- Prior caesarean section or uterine scar"}
  • {"criterion_text":"- Contra-indications to a vaginal delivery"}
  • {"criterion_text":"- Foetus with suspected severe congenital abnormalities"}
  • {"criterion_text":"- Pathological foetal heart rate"}
  • {"criterion_text":"- Contra-indications to prostaglandins (ANGUSTA®, PROPESS®, PROSTINE®)"}
  • {"criterion_text":"- Contra-indications for using oxytocin"}
  • {"criterion_text":"- Woman in labor"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Rate of caesarean delivery, whatever the indication of the caesarean delivery","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Time from intervention to delivery in hours","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Delivery within 12 hours","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Maternal satisfaction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Need for induction with oxytocin (for women in the control group)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Indication of caesarean in case of caesarean delivery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Instrumental delivery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Indication for the use of instruments in case of instrumental delivery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Oxytocin augmentation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Uterine hyperstimulation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Suspicion of per-partum infection","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Post-partum haemorrhage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Severe post-partum haemorrhage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Anal sphincter injury","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Blood transfusion","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Need for antibiotics","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cardiorespiratory arrest","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Damage to internal organs","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hysterectomy for any complications resulting from birth","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Pulmonary embolus","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stroke","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Admission to intensive care unit","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Maternal death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: birth trauma","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: hypoxic ischaemic encephalopathy","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: need for therapeutic hypothermia","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: meconium aspiration syndrome","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: need for respiratory support","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: neonatal seizures","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: neonatal acidosis","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: Early neonatal infection","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: Admission in an intensive care unit","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neonatal morbidity: death of the baby","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion of incremental cost-effect pairs that lies into the non-inferiority area, for various values of economic non–inferiority margin, and for a constant clinical non-inferiority margin (7%).","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1494
Recruitment Window Months
62
Consent Approach
Written informed consent is required (inclusion criterion: "Written informed consent"). The protocol states that midwives/physicians will inform eligible women, answer questions, allow as much time as necessary to decide, and obtain a signed consent at inclusion prior to randomization. Participants must be ≥ 18 years old. Subject information and informed consent form documents are listed (L1_SIS and ICF). Languages of consent documents are not specified in the record.

Methods

  • Eligible women will be informed of the study objectives by midwives/physicians in maternity units; their questions will be answered and they will be allowed as much time as necessary to decide; if they agree, inclusion is made with consent signature and randomization.

Geography

Total Number Of Sites
14
Total Number Of Participants
1494

France

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
514
Number Of Sites
14
Number Of Participants
1494

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Loic SENTILHES
Principal Investigator Email
loic.sentilhes@chu-bordeaux.fr
Contact Person Name
Loic SENTILHES
Contact Person Email
loic.sentilhes@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional D'Angers
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Guillaume LEGENDRE
Principal Investigator Email
guillaume.Legendre@chu-angers.fr
Contact Person Name
Guillaume LEGENDRE
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
François GOFFINET
Principal Investigator Email
francois.goffinet@aphp.fr
Contact Person Name
François GOFFINET
Contact Person Email
francois.goffinet@aphp.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Jordan POZZI
Principal Investigator Email
jordan.pozzi@chu-brest.fr
Contact Person Name
Jordan POZZI
Contact Person Email
jordan.pozzi@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Tiphaine BARJAT
Principal Investigator Email
tiphaine.barjat@chu-st-etienne.fr
Contact Person Name
Tiphaine BARJAT
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Denis GALLOT
Principal Investigator Email
dgallot@chu-clermontferrand.fr
Contact Person Name
Denis GALLOT
Contact Person Email
dgallot@chu-clermontferrand.fr
Site Name
Hopital Saint Joseph
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Raoul DESBRIERE
Principal Investigator Email
rdesbriere@hopital-saint-joseph.fr
Contact Person Name
Raoul DESBRIERE
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Floranne MEUNIER
Principal Investigator Email
floranne.meunier@chu-orleans.fr
Contact Person Name
Floranne MEUNIER
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Norbert WINER
Principal Investigator Email
norbert.winer@chu-nantes.fr
Contact Person Name
Norbert WINER
Contact Person Email
norbert.winer@chu-nantes.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Franck PERROTIN
Principal Investigator Email
franck.perrotin@med.univ-tours.fr
Contact Person Name
Franck PERROTIN
Site Name
CHRU De Nancy
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Charline BERTHOLDT
Principal Investigator Email
c.bertholdt@chru-nancy.fr
Contact Person Name
Charline BERTHOLDT
Contact Person Email
c.bertholdt@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Anne Cécile PIZZOFERRATO
Principal Investigator Email
anne-cecile.pizzoferrato@chu-poitiers.fr
Contact Person Name
Anne Cécile PIZZOFERRATO
Site Name
Hopital NOVO
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Christophe PONCELET
Principal Investigator Email
christophe.poncelet@ght-novo.fr
Contact Person Name
Christophe PONCELET
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Gynaecology-Obstetrics
Principal Investigator Name
Virginie COLLIN-BUND
Principal Investigator Email
virginie.bund@chru-strasbourg.fr
Contact Person Name
Virginie COLLIN-BUND

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Regional Universitaire De Tours
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
OXYTOCINE PANPHARMA 5 UI/1 ml, solution injectable
Active Substance
Oxytocin
Modality
Peptide/protein/enzyme
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
10 U unit(s) (max daily dose)
Investigational Product Name
PROPESS 10 mg, système de diffusion vaginal
Active Substance
Dinoprostone
Modality
Small molecule
Routes Of Administration
Vaginal use
Route
Vaginal
Authorisation Status
Authorised
Starting Dose
10 mg (product name)
Maximum Dose
10 mg (max total)
Investigational Product Name
PROSTINE E2 2 mg/3 g, gel vaginal
Active Substance
Dinoprostone
Modality
Small molecule
Routes Of Administration
Vaginal use
Route
Vaginal
Authorisation Status
Authorised
Starting Dose
2 mg/3 g (product name)
Maximum Dose
6 mg (max daily dose as listed)
Investigational Product Name
ANGUSTA 25 microgrammes, comprime
Active Substance
Misoprostol
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
Authorised
Starting Dose
25 microgrammes (product name)
Maximum Dose
200 mg (max daily dose as listed)

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