About this trial
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.
The participants' experiences will be compared using the QEVA self-assessment questionnaire, completed two days after delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged over 18
Patients who gave their written consent after receiving information to enable them to make an informed decision about the study
Patients with a medical or non-medical indication for induction of labour who are admitted to the maternity ward of the participating centre
Disqualifiers
Patients with a history of uterine scarring (a history of uterine scarring is a contraindication to prostaglandins)
Patients requiring urgent maturation
Patients requiring induction of labour in connection with a medical termination of pregnancy or foetal death in utero
Patients who are unable to complete the questionnaire (due to a lack of proficiency in the language, cognitive impairments, etc.)
Trial design
Parallel
Treatments tested in this trial
The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her
Other interventionChoice 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).
Standard Care (in control arm)
Other interventionCervical 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.
Treatment groups
Trial outcomes
Primary outcomes
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 / 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.
Secondary outcomes
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 / 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.
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 / 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.
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 / 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.
Procedures for informing patients about their experience of childbirth
Multiple choice: 1/information provided by a healthcare professional during a consultation (the patient's referring obstetrician or midwife), 2/our hospital's patient information leaflet, 3/antenatal classes, and 4/other sources (social media, etc.), expressed as percentages of the total number of participants.
Sponsors and contacts
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