[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658650":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":52,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":89,"collaborators":33,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":33,"enrollmentInfo":101,"targetDuration":33,"studyType":104,"phases":105,"briefSummary":37,"conditions":107,"keywords":111,"overallStatus":113,"whyStopped":33,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Centre Hospitalier Régional Metz-Thionville","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Score of the first dimension of the QEVA questionnaire","Total score of the dimension: 'emotions during childbirth' from the Questionnaire Assessing the Childbirth Experience (QACE \u002F Questionnaire d'Evaluation du Vécu de l'Accouchement, QEVA in French). The score ranges from 5 to 20, a higher score means a worse outcome.","2 days after giving birth",[14,17,20,23,26,30],{"measure":15,"description":16,"timeFrame":12},"Score of the second dimension of the QEVA questionnaire","Total score of the dimension 'interactions with healthcare professionals' from the Questionnaire Assessing the Childbirth Experience (QACE \u002F Questionnaire d'Évaluation du Vécu de l'Accouchement, QEVA in French). The score ranges from 5 to 20, a higher score means a worse outcome.",{"measure":18,"description":19,"timeFrame":12},"Score of the third dimension of the QEVA questionnaire","Total score of the dimension 'first moments with the baby' from the Questionnaire Assessing the Childbirth Experience (QACE \u002F Questionnaire d'Évaluation du Vécu de l'Accouchement, QEVA in French). The score ranges from 3 to 12, a higher score means a worse outcome.",{"measure":21,"description":22,"timeFrame":12},"Score of the fourth dimension of the QEVA questionnaire","Total score of the dimension : 'feeling during the postpartum period' from the Questionnaire Assessing the Childbirth Experience (QACE \u002F Questionnaire d'Évaluation du Vécu de l'Accouchement, QEVA in French). The score ranges from 4 to 16, a higher score means a worse outcome.",{"measure":24,"description":25,"timeFrame":12},"Procedures for informing patients about their experience of childbirth","Multiple choice: 1\u002Finformation provided by a healthcare professional during a consultation (the patient's referring obstetrician or midwife), 2\u002Four hospital's patient information leaflet, 3\u002Fantenatal classes, and 4\u002Fother sources (social media, etc.), expressed as percentages of the total number of participants.",{"measure":27,"description":28,"timeFrame":29},"Impact of the duration of antenatal care on the experience of childbirth","Assessment of the duration of care from the start of maturation to birth (days)","At baseline",{"measure":31,"description":32,"timeFrame":29},"Impact of the maturation technique used on the experience of childbirth","Assessment of the impact of the ripening technique used on the childbirth experience for the following techniques: the 10 mg vaginal dinoprostone delivery system (Propess), oral misoprostol (Angusta, 25 µg tablets), 1 mg or 2 mg vaginal dinoprostone gel (Prostine) and the extra-amniotic balloon (Cook balloon)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NON_RANDOMIZED","PARALLEL","This is a prospective, single-centre, quasi-experimental before-and-after study. Women due to give birth at the participating centre will be informed about the study during their 9th-month antenatal appointment. Only expectant mothers for whom cervical ripening is indicated will be included. During the BEFORE period, cervical ripening will be offered to them according to the method chosen by the healthcare team following a discussion of their case at a team meeting. During the AFTER period, the various possible methods of cervical ripening will be offered to the patient, and the choice of method will be left to her.\n\nThe participants' experiences will be compared using the QEVA self-assessment questionnaire, completed two days after delivery.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","Induction of labour is a common practice in France, and the rate is rising. Cervical ripening and induction of labour are often associated with negative maternal experiences of labour and childbirth. The experience of childbirth has a significant influence on the early mother-child relationship, as well as on the relationship between the parents. A negative experience of childbirth is a major risk factor for postnatal depression and post-traumatic stress disorder.",[43,47],{"label":44,"type":6,"description":33,"interventionNames":45},"Period before",[46],"Other: Standard Care (in control arm)",{"label":48,"type":49,"description":33,"interventionNames":50},"Period after","EXPERIMENTAL",[51],"Other: The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her",[53,57],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":33},"The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her","Choice of cervical ripening technique from the following: the 10 mg vaginal dinoprostone delivery system (Propess), oral misoprostol (Angusta®, 25 µg tablets), 1 mg or 2 mg vaginal dinoprostone gel (Prostine) and the extra-amniotic balloon (Cook balloon).",[48],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":33},"Standard Care (in control arm)","Cervical ripening will be offered to them in accordance with the approach chosen by the healthcare team following a discussion of her case at a team meeting.",[44],[62],{"name":63,"affiliation":64,"role":65},"Cristina-Elena DOROFTE, MD","CHR Metz Thionville Hopital Femme Mère Enfant","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":33,"email":71},"Mélanie JUNKE","CONTACT","0033387179886","projet-recherche-clinique@chr-metz-thionville.fr",[73],{"facility":74,"status":33,"city":75,"state":33,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"CHR METZ-THIONVILLE, Hôpital Femme Mère Enfant","Peltre","57245","France","FR",{"type":80,"coordinates":81},"Point",[82,83],6.22721,49.0748,{"lat":83,"lon":82},[86,87],{"name":68,"role":69,"phone":70,"phoneExt":33,"email":71},{"name":88,"role":65,"phone":33,"phoneExt":33,"email":33},"Dr Cristina-Elena DOROFTE, MD",{"type":90,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100658650","improving-the-childbirth-experience-for-women-who-have-undergone-cervical-ripening-by-involving-them-in-the-choice-of-ripening-technique-100658650",false,"NCT07855146","Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique","Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique : a Before-and-after Study","AVAPAM","Inclusion Criteria:\n\n* Female patients aged over 18\n* Patients who gave their written consent after receiving information to enable them to make an informed decision about the study\n* Patients with a medical or non-medical indication for induction of labour who are admitted to the maternity ward of the participating centre\n\nExclusion Criteria:\n\n* Patients with a history of uterine scarring (a history of uterine scarring is a contraindication to prostaglandins)\n* Patients requiring urgent maturation\n* Patients requiring induction of labour in connection with a medical termination of pregnancy or foetal death in utero\n* Patients who are unable to complete the questionnaire (due to a lack of proficiency in the language, cognitive impairments, etc.)\n* Women deprived of their liberty and\u002For protected by law","FEMALE","18 Years",{"count":102,"type":103},204,"ESTIMATED","INTERVENTIONAL",[106],"NA",[108,109,110],"Pregnancy","Cervical Ripening","Childbirth",[112],"Overall experience of childbirth","NOT_YET_RECRUITING","2026-09-29",{"date":116,"type":117},"2026-10-02","ACTUAL",{"date":119,"type":103},"2026-09",{"date":121,"type":103},"2027-09",{"name":5,"class":6},1]