Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville

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 volunteers

Qualifiers

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

Design model

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 intervention

    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).

  • Standard Care (in control arm)

    Other intervention

    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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Period beforeOther 1 intervention
Group B: Period afterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 days after giving birth

Secondary outcomes

1

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.

Time frame
2 days after giving birth
2

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.

Time frame
2 days after giving birth
3

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.

Time frame
2 days after giving birth
4

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.

Time frame
2 days after giving birth

Other outcomes

Sponsors and contacts

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