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.
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
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.
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)
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
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
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
Spontaneous vaginal deliveries
Rate of spontaneous vaginal deliveries,
Measured: 48 hours maximum
Rate of instrument-assisted vaginal deliveries
Rate of instrument-assisted vaginal deliveries.
Measured: 48 hours maximum
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
Type of instrument-assisted vaginal deliveries
Type of instrumental extraction used for the delivery
.
Measured: 48 hours maximum
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
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
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
Time from labour-induction to birth (Caesarian births excluded),
Time from labour-induction to vaginal delivery
Measured: 48 hours maximum
Vaginal deliveries at H12
Rate of vaginal deliveries at 12 hours from start of labour-induction
Measured: 12 hours from start of induction
Vaginal deliveries at H24
Rate of vaginal deliveries at 24 hours from start of labour-induction
Measured: 24 hours from start of induction
Vaginal deliveries at H48
Rate of vaginal deliveries at 48 hours from start of labour-induction
Measured: 48 hours from start of induction
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
Propess
Rate of secondary or tertiary use of Propess (vaginal prostaglandine inserts)
Measured: up to 48 hours before birth
Balloon/Foley bulb
Rate of secondary or tertiary use of the cervical ripening balloon (Foley bulb)
Measured: 48 hours maximum
Oxytocine
Rate of secondary or tertiary use of intravenous Oxytocine
Measured: 48 hours maximum
Epidurals
Rate of epidural anesthaesia during labour
Measured: 48 hours maximum
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)
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)
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)
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
Maternal morbidity
Rate of uterine hypertonia (contraction > 2 minutes with slowing down of fœtal heartbeat)
Measured: 48 hours maximum
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
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
Maternal morbidity: transfusion rate
Rate of transfusions
Measured: 48 hours maximum
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
Maternal morbidity: rupture
Rate of uterine rupture
Measured: 48 hours maximum
Maternal morbidity: Chorioamniotitis
Chorioamniotitis (temperature > 38°C with fœtal tachycardia > 160 beats / minute)
Measured: 48 hours maximum
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
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
Neonatal morbidity: neonatal hospitalisation
Rate of neonatal pediatric hospitalisations
Measured: up to 48 hours after giving birth
Neonatal morbidity: infection
Bacteriologically-proven infection rate
Measured: up to 48 hours after giving birth
Maternal tolerance: bleeding
Metrorrhagia due to vaginal insert (dinoprostone) or cervical ripening balloon placement
Measured: up to 48 hours after giving birth
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
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
Maternal tolerance: pain after childbirth
Pain level recorded with a VAS at H2 of childbirth.
Measured: 2 hours after giving birth
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
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
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.
- First posted3 Sep 2019
- Study start2 Oct 2019
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vincent letouzey, M., Principal investigator, CHU de Nîmes Service de Gynécologie Obstétrique
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
- ClinicalTrials.gov ID
- NCT04075630
- Acronym / sponsor ID
- SATISFACC / NIMAO/2018-03/BC-01
- Conditions
- Labor Induction
- Keywords
- childbirth, oxytocin, prostaglandin, cervical ripening balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 3 Sep 2019 (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.
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).
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 ).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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.
- The patient has a medical indication for labour-induction.
Key exclusion criteria (7 listed)
- 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.
- The patient does not have the possibility to answer the questionnaire at 1 month
- Contra-indication for labour-induction or vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall patient satisfaction
Time frame: 2 hours after giving birth
Overall patient satisfaction evaluated via a 4-point Likert scale (1= not satisfied, 2 = moderately satisfied, 3 = satisfied, 4 = very satisfied) on a touchscreen.
41 secondary outcomes
Patient satisfaction evaluated via the W-DEQ questionnaire
Time frame: 2 hours after giving birth
Post-partum QEVA satisfaction questionnaire
Time frame: 1-2 months after giving birth
Different methods of labour-induction used
Time frame: 6 months after giving birth
Spontaneous vaginal deliveries
Time frame: 48 hours maximum
Rate of instrument-assisted vaginal deliveries
Time frame: 48 hours maximum
Reason for instrument-assisted vaginal deliveries
Time frame: 48 hours maximum
Type of instrument-assisted vaginal deliveries
Time frame: 48 hours maximum
Rate of Caesarian births
Time frame: 48 hours maximum
Reason for Caesarian births
Time frame: 48 hours maximum
Time from start of labour-induction to start of labour
Time frame: 48 hours maximum
Time from labour-induction to birth (Caesarian births excluded),
Time frame: 48 hours maximum
Vaginal deliveries at H12
Time frame: 12 hours from start of induction
Vaginal deliveries at H24
Time frame: 24 hours from start of induction
Vaginal deliveries at H48
Time frame: 48 hours from start of induction
Labour-induction failures
Time frame: 12 - 18 hours
Propess
Time frame: up to 48 hours before birth
Balloon/Foley bulb
Time frame: 48 hours maximum
Oxytocine
Time frame: 48 hours maximum
Epidurals
Time frame: 48 hours maximum
Bishop score evolution: Propess
Time frame: Until birth (48 hours maximum)
Bishop score evolution: Balloon/Foley bulb
Time frame: Until birth (48 hours maximum)
Bishop score evolution: Ocytocine
Time frame: Until birth (48 hours maximum)
Maternal morbidity
Time frame: 6 months after giving birth
Maternal morbidity
Time frame: 48 hours maximum
Maternal morbidity: moderate haemorrhage
Time frame: 48 hours maximum
Maternal morbidity: severe haemorrage
Time frame: 48 hours maximum
Maternal morbidity: transfusion rate
Time frame: 48 hours maximum
Maternal morbidity: amount of blood transfused
Time frame: 48 hours maximum
Maternal morbidity: rupture
Time frame: 48 hours maximum
Maternal morbidity: Chorioamniotitis
Time frame: 48 hours maximum
Maternal morbidity: infection
Time frame: 1 week after giving birth
Neonatal morbidity:asphyxia
Time frame: 5 minutes after giving birth
Neonatal morbidity: neonatal hospitalisation
Time frame: up to 48 hours after giving birth
Neonatal morbidity: infection
Time frame: up to 48 hours after giving birth
Maternal tolerance: bleeding
Time frame: up to 48 hours after giving birth
Maternal tolerance: pain due to overinflation of the balloon (Foley bulb)
Time frame: up to 48 hours after giving birth
Maternal tolerance: pain on 1st induction sequence
Time frame: up to 48 hours before birth
Maternal tolerance: pain after childbirth
Time frame: 2 hours after giving birth
Maternal tolerance: pain during childbirth
Time frame: labour time
Maternal tolerance: pain due to insert or balloon (Foley bulb)
Time frame: up to 48 hours before birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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. This study is not recruiting at the moment.
vincent letouzey, M. principal investigator
CHU de Nîmes Service de Gynécologie Obstétrique
2 sites in 1 country: see every site and its status.
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.