PregnancyAVAPAMNCT07855146
Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique
A study testing The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her in people with Pregnancy and Cervical Ripening, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Cervical Ripening, Childbirth
- What is being tested?
- The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHR METZ-THIONVILLE, Hôpital Femme Mère Enfant
Peltre, 57245
Mélanie JUNKE, 0033387179886, projet-recherche-clinique@chr-metz-thionville.fr
Dr Cristina-Elena DOROFTE, MD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Pregnancy, Cervical Ripening, Childbirth
- Being tested
- The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her, Standard Care (in control arm)
- Keywords
- Overall experience of childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to herOther
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
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 group | Role | What they receive |
|---|---|---|
| Period before | Other | Not described Receives: Other: Standard Care (in control arm) |
| Period after | Experimental | Not described Receives: Other: The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days after giving birth
Secondary outcomes (6)
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.
Measured: 2 days after giving birth
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.
Measured: 2 days after giving birth
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.
Measured: 2 days after giving birth
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.
Measured: 2 days after giving birth
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)
Measured: At baseline
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)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina-Elena DOROFTE, MD, Principal investigator, CHR Metz Thionville Hopital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855146
- Sponsor's protocol ID
- 2026-02-CHRMT
- Acronym
- AVAPAM
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07855146
- Acronym / sponsor ID
- AVAPAM / 2026-02-CHRMT
- Conditions
- Pregnancy, Cervical Ripening, Childbirth
- Keywords
- Overall experience of childbirth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Period before | Other | Other: Standard Care (in control arm) |
| Period after | Experimental | Other: The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to herChoice 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). | Other | Period after |
| 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. | Other | Period before |
Primary outcome
Score of the first dimension of the QEVA questionnaire
Time frame: 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.
6 secondary outcomes
Score of the second dimension of the QEVA questionnaire
Time frame: 2 days after giving birth
Score of the third dimension of the QEVA questionnaire
Time frame: 2 days after giving birth
Score of the fourth dimension of the QEVA questionnaire
Time frame: 2 days after giving birth
Procedures for informing patients about their experience of childbirth
Time frame: 2 days after giving birth
Impact of the duration of antenatal care on the experience of childbirth
Time frame: At baseline
Impact of the maturation technique used on the experience of childbirth
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina-Elena DOROFTE, MD principal investigator
CHR Metz Thionville Hopital Femme Mère Enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patient will be offered the various possible methods of inducing cervical ripening, and the choice of method will be left to her in people with Pregnancy and Cervical Ripening, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie JUNKE (0033387179886, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the first dimension of the QEVA questionnaire (time frame: 2 days after giving birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.