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Starting soon Not applicable

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

NCT07855146 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-10-02

Condition(s) studied

PregnancyCervical RipeningChildbirth

Investigational drug(s) / intervention(s)

The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to herStandard Care (in control arm)

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).

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.

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.) * Women deprived of their liberty and/or protected by law

Primary outcome measure(s)

  • Score of the first dimension of the QEVA questionnaire — 2 days after giving birth
    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.

Trial sites (1)

FacilityCityRegionStatus
CHR METZ-THIONVILLE, Hôpital Femme Mère Enfant Peltre France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07855146 on ClinicalTrials.gov ↗ ← All trials in France