Dinoprostone Vaginal InsertNCT03482531
Assessing a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
An observational study of Dinoprostone Vaginal Insert, run by University Hospital, Angers at 1 site in France.
Trial summary
Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop <6), induction of labor is preceded by cervical ripening, usually with prostaglandins. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dinoprostone Vaginal Insert
- What is being tested?
- mathematical model
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 1 Nov 2019
- How long will I take part?
- 2 Days
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All eligible patients with a vaginal dinoprostone insert for cervical ripening ( because of not favorable cervical conditions (bishop <6) and needing induction of labor)
Who may be able to join
- have cervical ripening with the dinoprostone vaginal insert
- 34 weeks gestational age (GA) and beyond
- singleton pregnancies
- cephalic presentations
Who cannot join
- term < 34 weeks GA
- previous history of cesarean section
- women who refuse to participate in the study or have their data used.
- twin pregnancy
- prostaglandin allergies
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Angers University hospital
Angers, Maine Et Loire, 49000
BOUET Pierre-emmanuel, doctor, (+33) 02.41.35.42.13, PierreEmmanuel.Bouet@chu-angers.fr
About this study
Official title: Assessing, Depending on Personalized Manner, a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop <6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents.
Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice.
The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.
Read the detailed description
This is a before-after, retrospective and prospective monocentric study. Patients in the "before" group were part of another study which are currently in the process of publishing and were retrospectively included, whereas patients in the "after" group will be prospectively included.
In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. The main outcome of the previous study was to evaluate the time interval between placing the dinoprostone vaginal insert and delivery. One of the secondary objectives was to determine the factors that would impact the time to delivery. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient:
Y = 961,188 - 80,346 x parity + 21,437 x Body Mass Index (BMI) - 165,263 x cervical dilation- 241,759 x Premature rupture of membranes.
Following this study, the investigators decided to modify the routine procedures on the maternity ward and incorporate the equation when scheduling patients for cervical ripening with vaginal dinoprostone insert. The aim is to have a more personalized insertion schedule that would lower the number of deliveries occurring between midnight and 6 a.m., since it has been proven that there is a higher risk of obstetrical morbidity with night-time labor and delivery.
The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so 400 to 500 patients will be included during the study's duration. The investigators will then compare the outcomes in these patients that will comprise the "after" group, to the outcomes of patients in the "before" group, who delivered before the implementation of the new scheduling process. The investigators will thus be able to able to assess whether the mathematical model they suggested to estimate time to delivery and the personalized insertion timings have been confirmed. Then, subsequently, the objective is to analyze whether the use of the personalized scheduling based on the mathematical model they described would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.).
The research project has been approved by the ethics committee of Angers university hospital on January 31st, 2018.
- Conditions
- Dinoprostone Vaginal Insert
- Being tested
- mathematical model
- Keywords
- limit nocturnal activity, cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mathematical modelOther
mathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes)
| Study group | Role | What they receive |
|---|---|---|
| before group | In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient. | |
| after group | The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so the investigators will be able to include 400 to 500 patients during the study's duration.
The equation will be incorporated when scheduling patients for cervical ripening with vaginal dinoprostone insert. The main objective of this study is to analyze to evaluate our mathematical model. One of the secondary objectives is to analyze whether the use of the personalized scheduling based on the mathematical model would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.). Receives: Other: mathematical model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference (in minutes) between the actual time to delivery compared to the predicted time
there will be different categories:
- less than 180 minutes
- more than 180 but less than 360 minutes
- more than 360 but less than 540 minutes
- more than 540 but less than 720 minutes
- more than 720 minutes
Measured: 2 days
Secondary outcomes (7)
rate of deliveries
rate of deliveries occurring between midnight and 6 a.m. following cervical ripening with dinoprostone vaginal insert.
Measured: 2 years
the Apgar score
Apgar score lower than 7 at 1, 3 and 5 minutes. Apgar score lower than 7 at 5 minutes is correlated on the immediate child's development
Measured: 1, 3 and 5 minutes after delivery
neonatal potential of hydrogen (pH)
- mean of neonatal potential of hydrogen (pH)
- potential of hydrogen < 7.20 means foetal acidosis
- potential of hydrogen is measured in the artery of umbilical cordon few minutes after delivery
- potential of hydrogen lower than 7 leads to foetal acidosis responsible for neonatal encephalopathy
Measured: 1 hour
neonatal intensive care hospitalization
The rate of neonatal intensive care hospitalization in the immediate postpartum and during the 12 hours after delivery
Measured: 12 hours
post-partum bleeding
- the rate of post-partum bleeding
- postpartum hemorrhage is a bleeding more than 500ml
- severe postpartum hemorrhage is a bleeding more than 1000ml
Measured: 24 hours
Operative deliveries
the rate of forceps deliveries and vacuum extractions during the study duration
Measured: 2 years
Cesarean sections
the rate of cesarean sections during the study duration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dinoprostone Vaginal InsertStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482531
- Sponsor's protocol ID
- PHRC 2018-03
- Status last verified
- May 2018
- First submitted
- 8 Mar 2018
- Last updated
- 30 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing, Depending on Personalized Manner, a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert
- ClinicalTrials.gov ID
- NCT03482531
- Acronym / sponsor ID
- PHRC 2018-03
- Conditions
- Dinoprostone Vaginal Insert
- Keywords
- limit nocturnal activity, cervical ripening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 29 Mar 2018 (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.
Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop <6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents.
Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice.
The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.
Detailed description
This is a before-after, retrospective and prospective monocentric study. Patients in the "before" group were part of another study which are currently in the process of publishing and were retrospectively included, whereas patients in the "after" group will be prospectively included.
In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. The main outcome of the previous study was to evaluate the time interval between placing the dinoprostone vaginal insert and delivery. One of the secondary objectives was to determine the factors that would impact the time to delivery. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient:
Y = 961,188 - 80,346 x parity + 21,437 x Body Mass Index (BMI) - 165,263 x cervical dilation- 241,759 x Premature rupture of membranes.
Following this study, the investigators decided to modify the routine procedures on the maternity ward and incorporate the equation when scheduling patients for cervical ripening with vaginal dinoprostone insert. The aim is to have a more personalized insertion schedule that would lower the number of deliveries occurring between midnight and 6 a.m., since it has been proven that there is a higher risk of obstetrical morbidity with night-time labor and delivery.
The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so 400 to 500 patients will be included during the study's duration. The investigators will then compare the outcomes in these patients that will comprise the "after" group, to the outcomes of patients in the "before" group, who delivered before the implementation of the new scheduling process. The investigators will thus be able to able to assess whether the mathematical model they suggested to estimate time to delivery and the personalized insertion timings have been confirmed. Then, subsequently, the objective is to analyze whether the use of the personalized scheduling based on the mathematical model they described would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.).
The research project has been approved by the ethics committee of Angers university hospital on January 31st, 2018.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before group | – | –In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient. |
| after group | – | Other: mathematical modelThe investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so the investigators will be able to include 400 to 500 patients during the study's duration. The equation will be incorporated when scheduling patients for cervical ripening with vaginal dinoprostone insert. The main objective of this study is to analyze to evaluate our mathematical model. One of the secondary objectives is to analyze whether the use of the personalized scheduling based on the mathematical model would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients with a vaginal dinoprostone insert for cervical ripening ( because of not favorable cervical conditions (bishop <6) and needing induction of labor)
Key inclusion criteria (4 listed)
- have cervical ripening with the dinoprostone vaginal insert
- 34 weeks gestational age (GA) and beyond
- singleton pregnancies
- cephalic presentations
Key exclusion criteria (5 listed)
- term < 34 weeks GA
- previous history of cesarean section
- women who refuse to participate in the study or have their data used.
- twin pregnancy
- prostaglandin allergies
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 |
|---|---|---|
| mathematical modelmathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes) | Other | after group |
Primary outcome
Difference (in minutes) between the actual time to delivery compared to the predicted time
Time frame: 2 days
there will be different categories: * less than 180 minutes * more than 180 but less than 360 minutes * more than 360 but less than 540 minutes * more than 540 but less than 720 minutes * more than 720 minutes
7 secondary outcomes
rate of deliveries
Time frame: 2 years
the Apgar score
Time frame: 1, 3 and 5 minutes after delivery
neonatal potential of hydrogen (pH)
Time frame: 1 hour
neonatal intensive care hospitalization
Time frame: 12 hours
post-partum bleeding
Time frame: 24 hours
Operative deliveries
Time frame: 2 years
Cesarean sections
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Undecided
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.
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 Dinoprostone Vaginal Insert, run by University Hospital, Angers 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 4 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: status not confirmed, as of the sponsor's last update on 30 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BOUET Pierre-emmanuel, doctor ((+33)02.41.35.42.13, PierreEmmanuel.Bouet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference (in minutes) between the actual time to delivery compared to the predicted time (time frame: 2 days). 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 30 May 2018.