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Labor InductionSATISFACCNCT04075630

Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

An observational study of Labor Induction, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories : Maternal satisfaction depends on the number of labour-inducing sequences A longer labour-induction would be experienced less positively than… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Induction
How many people
260 participants
Where
2 sitesFrance
Study dates
2 Oct 2019to 9 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Women 18+ admitted to gynecology-obstetric depts. of Montpellier \& Nîmes University Hospitals for artificial labor-induced childbirth. Sociodemographic and medical variables will be noted: patient's knowledge of labor-induction, labor in childbirth, age, weight, height (BMI), no. of previous pregnancies, childbirths, miscarriages, abortions, medically-motivated induced terminations, medical antecedents (comorbidities), important surgery (esp. uterine), ongoing treatment, tobacco/alcohol/cannabis intake, Down's syndrome screening, pregnancy particularities (medically-assisted procreation), antenatal diagnosis, no. of hospital consultations, gestational age at admission, information received, other newborn data (term, weight, size, cranial perimeter at birth), reason for induction.

Who may be able to join

  • The patient has made no formal opposition to taking part in the study.
  • The patient must be affiliated to/have the benefit of a health insurance scheme.
  • The patient is at least 18 years old.
  • The patient is capable of understanding the instructions required for answering questionnaires in French.
  • Concerning the targeted population:
  • The patient has a medical indication for labour-induction.
  • Term ≥ 37 weeks.
  • The foetus is alive and viable, without any known lethal pathology

Who cannot join

  • The person is in a period of exclusion determined by a previous study.
  • The person has been placed under judicial protection and is under guardianship or curatorship.
  • It is impossible to give the person accurate information.
  • Non-inclusion criteria concern associated illnesses or interfering conditions:
  • The patient does not have the possibility to answer the questionnaire at 1 month
  • Contra-indication for labour-induction or vaginal delivery
  • Foetal presentation other than cephalic.

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique

    Montpellier, Hérault, 34090

  • Centre Hospitalier Universitaire

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories :

  • Maternal satisfaction depends on the number of labour-inducing sequences
  • A longer labour-induction would be experienced less positively than a shorter one
  • The experience is correlated with maternal outcomes ( vaginal / Caesarian delivery, spontaneous birth or instrument-assisted birth, maternal complications ) and neonatal outcomes (neonatal complications, secondary hospitalization).
Read the detailed description

Artificial labour induction is a medical intervention used in the interest of the mother or unborn child, aimed at provoking birth by inducing uterine contractions artificially, leading to cervical effacement and dilation. The purpose is to end the pregnancy in the interest of the mother and/or foetus.

According to the latest results of the Perinatal Enquiry (2016), induced labour rates total around 22% of pregnancies (767.000 births in 2017) in all maternity clinics. For the university hospitals of Nimes and Montpellier, with Level 3 maternity units (thus requiring a higher rate of inductions), this represents 515 and 550 pregnancies respectively (2017 figures).

There are several methods of inducing labour: use of a cervical ripening balloon (a medical device with which the onset of labour is provoked mechanically), vaginal inserts containing prostaglandins or intravenous perfusion with oxytocin combined with water-breakage. These labour-induction methods may be used alone or in succession depending on the evaluation of the cervix using the Bishop score as a reference. Each method has its own benefits and risks.

There is variability between establishments in the protocols used for cervical ripening.

The Nimes and Montpellier centres both use the same methods, but with different sequences.

Studies are mainly devoted to evaluating each method individually in terms childbirth by vaginal delivery and duration of labour.

Maternal satisfaction, which is a rarely studied multifactorial evaluation, is correlated with women's psychological outcome. A bad experience during childbirth appears to increase the risk of post-partum (PP) psychological disorders.

Considering the current literature available, although there have been trials comparing two isolated labour-induction methods, like the study by Probaat (Jozwiak et al., 2013), which compared obstetrical and neonatal outcomes with the cervical ripening balloon and the prostaglandin insert, none of these studies investigated their impact on maternal satisfaction. Although there have been a few studies evaluating maternal satisfaction at childbirth, there have not been any evaluating satisfaction during artificial labour-induction in a pragmatic situation.

The aim of our study was therefore to evaluate the impact on semi-immediate maternal satisfaction under pragmatic, real-life conditions depending on the various possible induction scenarios (both in terms of the number of methods used, from 1 to 3, and the possible combinations when at least 2 or more methods were used ).

Conditions
Labor Induction
Keywords
childbirth, oxytocin, prostaglandin, cervical ripening balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall patient satisfaction

    Overall patient satisfaction evaluated via a 4-point Likert scale (1= not satisfied, 2 = moderately satisfied, 3 = satisfied, 4 = very satisfied) on a touchscreen.

    Measured: 2 hours after giving birth

Secondary outcomes (41)
  1. Patient satisfaction evaluated via the W-DEQ questionnaire

    The Wijma Delivery Experience Questionnaire (W-DEQ) is a Scandinavian questionnaire (designed by Wijma et al. in 1998) translated into French. It evaluates the patient's true experience of childbirth compared with her expectations. It has 33 items based on recurring fears of pregnant women, divided into several catégories (fear, negative feelings, lack of confidence, behaviour etc…).

    Measured: 2 hours after giving birth

  2. Post-partum QEVA satisfaction questionnaire

    The pluridimensional Questionnaire d'Evaluation du Vécu de l'Accouchement (QEVA) known in English as the QACE (Questionnaire for Assessing the Childbirth Experience is used to evaluate the patient's experience of childbirth. It contains 25 items, each with a 4-point Likert scale, divided into the following categories: relationship with healthcare teams, emotions (positive and negative), first moments with the newborn baby, situation one month after childbirth. An e-mail is sent to the patient 1 month after giving birth, asking her to complete the QEVA by logging onto a dedicated platform.

    Measured: 1-2 months after giving birth

  3. Different methods of labour-induction used

    Data collection from medical files on the methods of labour-induction used (alone or successively), duration of use and intermediate Bishop scores. This a pre-labor scoring system reflecting cervical modification ranges from 0 to 3 (0= cervix closed and 3 = dilated to more than 5 cm) assists in predicting whether labour-induction will be required and the likelihood of spontaneous preterm delivery.

    Measured: 6 months after giving birth

  4. Spontaneous vaginal deliveries

    Rate of spontaneous vaginal deliveries,

    Measured: 48 hours maximum

  5. Rate of instrument-assisted vaginal deliveries

    Rate of instrument-assisted vaginal deliveries.

    Measured: 48 hours maximum

  6. Reason for instrument-assisted vaginal deliveries

    Reason for instrument-assisted vaginal deliveries (non progression of fœtal presentation, fœtal distress, maternal complications).

    Measured: 48 hours maximum

  7. Type of instrument-assisted vaginal deliveries

    Type of instrumental extraction used for the delivery

    .

    Measured: 48 hours maximum

  8. Rate of Caesarian births

    Rate of Caesarian births and reason (no cervical dilatation at the first stage of labour : dilatation 0 to 10cm, absence of fœtal descent at stage 2 of labour, fœtal cause, maternal cause).

    Measured: 48 hours maximum

  9. Reason for Caesarian births

    Reason for Caesarian birth (no cervical dilatation at the first stage of labour : dilatation 0 to 10cm, absence of fœtal descent at stage 2 of labour, fœtal cause, maternal cause).

    Measured: 48 hours maximum

  10. Time from start of labour-induction to start of labour

    Time between the start of labour-induction and the onset of labour will be measured

    Measured: 48 hours maximum

  11. Time from labour-induction to birth (Caesarian births excluded),

    Time from labour-induction to vaginal delivery

    Measured: 48 hours maximum

  12. Vaginal deliveries at H12

    Rate of vaginal deliveries at 12 hours from start of labour-induction

    Measured: 12 hours from start of induction

  13. Vaginal deliveries at H24

    Rate of vaginal deliveries at 24 hours from start of labour-induction

    Measured: 24 hours from start of induction

  14. Vaginal deliveries at H48

    Rate of vaginal deliveries at 48 hours from start of labour-induction

    Measured: 48 hours from start of induction

  15. Labour-induction failures

    Rate of labour-induction failures giving rise to a Caesarian due to the duration of the latency phase (0-6cm) ≥24h with oxytocine administered for at least 12-18h after artificial water-breakage.

    Measured: 12 - 18 hours

  16. Propess

    Rate of secondary or tertiary use of Propess (vaginal prostaglandine inserts)

    Measured: up to 48 hours before birth

  17. Balloon/Foley bulb

    Rate of secondary or tertiary use of the cervical ripening balloon (Foley bulb)

    Measured: 48 hours maximum

  18. Oxytocine

    Rate of secondary or tertiary use of intravenous Oxytocine

    Measured: 48 hours maximum

  19. Epidurals

    Rate of epidural anesthaesia during labour

    Measured: 48 hours maximum

  20. Bishop score evolution: Propess

    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

    Measured: Until birth (48 hours maximum)

  21. Bishop score evolution: Balloon/Foley bulb

    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

    Measured: Until birth (48 hours maximum)

  22. Bishop score evolution: Ocytocine

    The Bishop score,developed by Professor Emeritus of Obstetrics and Gynecology Dr. Edward Bishop, is also known as cervix score. It is a pre-labor scoring system to assist in predicting whether induction of labor will be required. It is based on 5 points : Cervical dilation in centimeters, cervical effacement as a percentage,cervical consistency by provider assessment/judgement, cervical position, fetal station (the position of the fetal head in relation to the pelvic bones).The Bishop score grades patients who would be most likely to achieve a successful induction. The duration of labor is inversely correlated with the Bishop score; a score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth. Bishop scores of less than 6 usually require a cervical ripening method (pharmacologic or physical, such as a Foley bulb).

    Measured: Until birth (48 hours maximum)

  23. Maternal morbidity

    Rate of uterine hyperstimulation(> 6 contractions in 10 minutes on 2 occasions) with or without an effect on the foetus

    Measured: 6 months after giving birth

  24. Maternal morbidity

    Rate of uterine hypertonia (contraction > 2 minutes with slowing down of fœtal heartbeat)

    Measured: 48 hours maximum

  25. Maternal morbidity: moderate haemorrhage

    Rate of post partum haemorrage ≥ 500ml, rate of severe post-partum haemorrhage ≥1000ml, rate of transfusion, number of packs of red blood cells transfused

    Measured: 48 hours maximum

  26. Maternal morbidity: severe haemorrage

    rate of severe post-partum haemorrage ≥1000ml rate of transfusion, number of packs of red blood cells transfused

    Measured: 48 hours maximum

  27. Maternal morbidity: transfusion rate

    Rate of transfusions

    Measured: 48 hours maximum

  28. Maternal morbidity: amount of blood transfused

    This is measured in terms of the number of packs of red blood cells transfused

    Measured: 48 hours maximum

  29. Maternal morbidity: rupture

    Rate of uterine rupture

    Measured: 48 hours maximum

  30. Maternal morbidity: Chorioamniotitis

    Chorioamniotitis (temperature > 38°C with fœtal tachycardia > 160 beats / minute)

    Measured: 48 hours maximum

  31. Maternal morbidity: infection

    Rate of post-partum infection (temperature > 38°C with antibiotherapy, urinary infection, bacteriologically-proven endometritis at 1 week post-partum)

    Measured: 1 week after giving birth

  32. Neonatal morbidity:asphyxia

    Rate of neonatal asphyxia (umbilical cord arterial pH ≤ 7.05, and/or APGAR at 5 minutes < 7). The Apgar score is a means of evaluating the vitality of a newborn based on the simple observation at the time of birth. The value is a prognostic for neonatal mortality. It was developed in 1952 by the American doctor, Virginia Apgar.

    Measured: 5 minutes after giving birth

  33. Neonatal morbidity: neonatal hospitalisation

    Rate of neonatal pediatric hospitalisations

    Measured: up to 48 hours after giving birth

  34. Neonatal morbidity: infection

    Bacteriologically-proven infection rate

    Measured: up to 48 hours after giving birth

  35. Maternal tolerance: bleeding

    Metrorrhagia due to vaginal insert (dinoprostone) or cervical ripening balloon placement

    Measured: up to 48 hours after giving birth

  36. Maternal tolerance: pain due to overinflation of the balloon (Foley bulb)

    Pain related to balloon inflation requiring secondary partial deflation, reorded with a VAS. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

    Measured: up to 48 hours after giving birth

  37. Maternal tolerance: pain on 1st induction sequence

    Pain level recorded with a VAS before the 1st induction sequence. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

    Measured: up to 48 hours before birth

  38. Maternal tolerance: pain after childbirth

    Pain level recorded with a VAS at H2 of childbirth.

    Measured: 2 hours after giving birth

  39. Maternal tolerance: pain during childbirth

    Pain level at various times of labour-induction recorded with a VASThe visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

    Measured: labour time

  40. Maternal tolerance: pain due to insert or balloon (Foley bulb)

    Pain level recorded with a VAS before vaginal insert or balloon placement. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

    Measured: up to 48 hours before birth

  41. Maternal tolerance: pain due to insert or balloon (Foley bulb) at H2

    Pain level recorded with a VAS 2 hours after vaginal insert or balloon placement. The visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity

    Measured: 2 hours after device placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2019
  2. Study start2 Oct 2019
  3. Primary completion9 Jan 2024
  4. Study completion9 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075630
Sponsor's protocol ID
NIMAO/2018-03/BC-01
Acronym
SATISFACC
Status last verified
Feb 2025
First submitted
29 Aug 2019
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Induction, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall patient satisfaction (time frame: 2 hours 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 13 Feb 2025.

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