Induced; BirthNCT06272591
Comparison of Patient Satisfaction With Home Induction and In-patient Induction.
An observational study of Induced; Birth and Pregnancy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated. Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. 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
- Induced; Birth, Pregnancy
- What is being tested?
- Preliminary search in the patient's file, A posteriori research in the patient's file and First questionnaire : choice of induction method reason for choice
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2023to 30 Jun 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: Any pregnant woman with a singleton pregnancy, giving birth at the Saint-Etienne University Hospital, with an indication for induction of labour from 37SA. The indications could be for a maternal pathology, a maternal wish or a foetal pathology.
Who may be able to join
- Adult patient
- Singleton pregnancy
- Indication for induction of labour ≥ 37SA+0d
- Unfavourable cervix (Bishop<6)
- Living less than 30 minutes' drive from hospital
- Having a relative at her side for a return home
Who cannot join
- Scarred uterus : previous caesarean section or myomectomy
- Premature rupture of membranes
- Fetal death in utero
- Placenta previa/accreta/percreta
- Severe maternal pathology : decompensated respiratory, cardiac, hepatic, renal, digestive or psychiatric disease, severe pre-eclampsia, severe growth retardation or anamnios
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.
Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.
Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital.
Read the detailed description
There are generally two main methods of cervical ripening, mechanical methods (Foley® catheter or Cook® double balloon catheter) and pharmacological methods (Propess® dinoprostone intravaginal tampon, Prostine® intravaginal gel, or Angusta® oral misoprostol).
Balloon induction of labour works by the dilating effect of a balloon inflated at the level of the uterine cervix, which distinguishes it from pharmacological methods acting via uterine contractions.
Balloon induction has been shown to be effective and safe. It therefore seems important to take a closer look at this method of outpatient induction, especially as the risks of uterine hyperkinesia/hypertonia and anomalies in foetal heart rate are very low with this technique.
Several foreign studies have looked at outpatient induction of labour. Meta-analyses have shown a lower caesarean section rate with outpatient induction, faster labour and less administration of oxytocin.
In terms of safety, a systematic review of the literature based on data from 26 studies, published in 2018, showed a low risk of developing adverse effects between insertion and expulsion of the balloon. A meta-analysis conducted in 2020 compared inpatient versus outpatient induction of labour, showing no significant differences between the home and inpatient groups in terms of major neonatal adverse events. In addition, several studies have suggested that allowing patients to participate actively in the decision concerning the induction method can promote better understanding and acceptance of the process, thereby strengthening their commitment to their own health.
The obstetrics and gynecology department of the University hospital recently modified its protocol for the management of induced labour in order to allow a more free and informed choice of technique (information booklet, reflection period) and a return home for low-risk women after balloon insertion.
The aim of this work will be to demonstrate a link between women's choice of induction method and increased compliance with their care.
The aim of this study is to monitor the implementation of this new service protocol.
The aim of the study will be to analyse the experience and satisfaction of women who have undergone induction, comparing their experiences at home and in hospital.
This research is being carried out in a context in which the choice of induction, the methods used and the place of delivery are arousing growing interest in the medical community and among women themselves.
- Conditions
- Induced; Birth, Pregnancy
- Being tested
- Preliminary search in the patient's file, A posteriori research in the patient's file, First questionnaire : choice of induction method reason for choice, Second questionnaire : experience of induction
- Keywords
- Induced labour, Induction of labour, Cervical ripening, Inducing labour at home, Patient's choice of induction method, Experiences induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preliminary search in the patient's fileOther
Details of the information previously sought in the patient's file :
age profession gender/parity physiological or pathological pregnancy indication for induction of labour gestational age at time of induction
A posteriori research in the patient's fileOther
Data on maternal and foetal morbidity and mortality following childbirth will be collected.
First questionnaire : choice of induction method reason for choiceOther
Given on arrival at the maternity unit to begin induction.
Second questionnaire : experience of inductionOther
Given post-partum in the maternity unit.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with induction indication | Any pregnant woman, with a singleton pregnancy, giving birth at Saint-Etienne University Hospital, with an indication for induction of labour from 37SA will be included. The indications may be for a maternal pathology, a maternal wish or a foetal pathology. Receives: Other: Preliminary search in the patient's file; Other: A posteriori research in the patient's file; Other: First questionnaire : choice of induction method reason for choice; Other: Second questionnaire : experience of induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on patients' experience of induction in hospital and at home.
To compare patients' experiences of their induction in hospital or at home, using a questionnaire handed out after the birth.
Measured: Day 2
Questionnaire on patients' satisfaction of induction in hospital and at home.
To compare patients' satisfaction of their induction in hospital or at home, using a questionnaire handed out after the birth.
Measured: Day 2
Secondary outcomes (6)
Questionnaire on patients' choice of induction method
To analyse patients' choice of induction method and the reasons for it, using a questionnaire handed out on arrival at the maternity unit.
Measured: Day 0
Questionnaire on reasons for choosing home induction.
Analyse the reasons for choosing home induction based on the answers to the questionnaire given on arrival at the maternity unit.
Measured: Day 0
Maternal morbidity
To compare maternal morbidity between home and hospital induction.
Measured: Day 3
Maternal mortality
To compare maternal mortality between home and hospital induction.
Measured: Day 3
Neonatal morbidity
To compare neonatal morbidity between home and hospital induction.
Measured: Day 3
Neonatal mortality
To compare neonatal mortality between home and hospital induction.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start20 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 187 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine BARJAT, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272591
- Sponsor's protocol ID
- IRBN1192023/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction With Home Induction and In-patient Induction.
- ClinicalTrials.gov ID
- NCT06272591
- Acronym / sponsor ID
- IRBN1192023/CHUSTE
- Conditions
- Induced; Birth, Pregnancy
- Keywords
- Induced labour, Induction of labour, Cervical ripening, Inducing labour at home, Patient's choice of induction method, Experiences induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Feb 2024 (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.
Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.
Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.
Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital.
Detailed description
There are generally two main methods of cervical ripening, mechanical methods (Foley® catheter or Cook® double balloon catheter) and pharmacological methods (Propess® dinoprostone intravaginal tampon, Prostine® intravaginal gel, or Angusta® oral misoprostol).
Balloon induction of labour works by the dilating effect of a balloon inflated at the level of the uterine cervix, which distinguishes it from pharmacological methods acting via uterine contractions.
Balloon induction has been shown to be effective and safe. It therefore seems important to take a closer look at this method of outpatient induction, especially as the risks of uterine hyperkinesia/hypertonia and anomalies in foetal heart rate are very low with this technique.
Several foreign studies have looked at outpatient induction of labour. Meta-analyses have shown a lower caesarean section rate with outpatient induction, faster labour and less administration of oxytocin.
In terms of safety, a systematic review of the literature based on data from 26 studies, published in 2018, showed a low risk of developing adverse effects between insertion and expulsion of the balloon. A meta-analysis conducted in 2020 compared inpatient versus outpatient induction of labour, showing no significant differences between the home and inpatient groups in terms of major neonatal adverse events. In addition, several studies have suggested that allowing patients to participate actively in the decision concerning the induction method can promote better understanding and acceptance of the process, thereby strengthening their commitment to their own health.
The obstetrics and gynecology department of the University hospital recently modified its protocol for the management of induced labour in order to allow a more free and informed choice of technique (information booklet, reflection period) and a return home for low-risk women after balloon insertion.
The aim of this work will be to demonstrate a link between women's choice of induction method and increased compliance with their care.
The aim of this study is to monitor the implementation of this new service protocol.
The aim of the study will be to analyse the experience and satisfaction of women who have undergone induction, comparing their experiences at home and in hospital.
This research is being carried out in a context in which the choice of induction, the methods used and the place of delivery are arousing growing interest in the medical community and among women themselves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with induction indication | – | Other: Preliminary search in the patient's file, Other: A posteriori research in the patient's file, Other: First questionnaire : choice of induction method reason for choice, Other: Second questionnaire : experience of inductionAny pregnant woman, with a singleton pregnancy, giving birth at Saint-Etienne University Hospital, with an indication for induction of labour from 37SA will be included. The indications may be for a maternal pathology, a maternal wish or a foetal pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any pregnant woman with a singleton pregnancy, giving birth at the Saint-Etienne University Hospital, with an indication for induction of labour from 37SA. The indications could be for a maternal pathology, a maternal wish or a foetal pathology.
Key inclusion criteria (6 listed)
- Adult patient
- Singleton pregnancy
- Indication for induction of labour ≥ 37SA+0d
- Unfavourable cervix (Bishop<6)
- Living less than 30 minutes' drive from hospital
Key exclusion criteria (6 listed)
- Scarred uterus : previous caesarean section or myomectomy
- Premature rupture of membranes
- Fetal death in utero
- Placenta previa/accreta/percreta
- Severe maternal pathology : decompensated respiratory, cardiac, hepatic, renal, digestive or psychiatric disease, severe pre-eclampsia, severe growth retardation or anamnios
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 |
|---|---|---|
| Preliminary search in the patient's fileDetails of the information previously sought in the patient's file : age profession gender/parity physiological or pathological pregnancy indication for induction of labour gestational age at time of induction | Other | Pregnant women with induction indication |
| A posteriori research in the patient's fileData on maternal and foetal morbidity and mortality following childbirth will be collected. | Other | Pregnant women with induction indication |
| First questionnaire : choice of induction method reason for choiceGiven on arrival at the maternity unit to begin induction. | Other | Pregnant women with induction indication |
| Second questionnaire : experience of inductionGiven post-partum in the maternity unit. | Other | Pregnant women with induction indication |
Primary outcome
Questionnaire on patients' experience of induction in hospital and at home.
Time frame: Day 2
To compare patients' experiences of their induction in hospital or at home, using a questionnaire handed out after the birth.
Questionnaire on patients' satisfaction of induction in hospital and at home.
Time frame: Day 2
To compare patients' satisfaction of their induction in hospital or at home, using a questionnaire handed out after the birth.
6 secondary outcomes
Questionnaire on patients' choice of induction method
Time frame: Day 0
Questionnaire on reasons for choosing home induction.
Time frame: Day 0
Maternal morbidity
Time frame: Day 3
Maternal mortality
Time frame: Day 3
Neonatal morbidity
Time frame: Day 3
Neonatal mortality
Time frame: Day 3
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 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Tiphaine BARJAT, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Induced; Birth and Pregnancy, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 inclusion and 6 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 16 Jul 2024. 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?
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?
Questionnaire on patients' experience of induction in hospital and at home. (time frame: Day 2). The study lists 2 primary outcomes in all. 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 16 Jul 2024.