Induction of Labor Affected Fetus / NewbornMODOBATNCT04299854
Modality of Induction of Labor in Obese Women at Term (MODOBAT)
An observational study of Induction of Labor Affected Fetus / Newborn and Obese, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn, Obese
- What is being tested?
- Dinoprostone 10mg and single balloon Foley catheter
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jun 2020to 12 Dec 2020
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients of the level III maternity of university hospital center of Besançon and level IIB maternity of regional hospital of Trevenans, France.
Who may be able to join
- Age ≥ 18 years
- Medical indication of induction of labor
- BMI ≥ 30 kg / m2
- Bishop < 6
- Singleton
- Gestational age > 36 SA + 6j
- Cephalic presentation
Who cannot join
- Adults under guardianship or curatorship
- Scarred uterus
- Placenta praevia
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)
In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.
Read the detailed description
Obesity has for several decades become a global epidemic in developed countries. In case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. Unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. However, in this context effectiveness of each mode of induction is not known. Some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis.
The aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon Foley catheter arm will be included prospectively.
- Conditions
- Induction of Labor Affected Fetus / Newborn, Obese
- Being tested
- Dinoprostone 10mg, single balloon Foley catheter
- Keywords
- Induction of Labor, BMI, Obesity, caesarean, C-section, Pregnancy, Balloon, Dinoprostone
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone 10mgDrug
Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
single balloon Foley catheterDevice
A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Dinoprostone | Induction of labor by 10mg of vaginal dinoprostone Receives: Drug: Dinoprostone 10mg | |
| Single Balloon Foley Catheter | Induction of labor by single balloon Foley catheter Receives: Device: single balloon Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean sections
Rate of cesarean sections in each group
Measured: 1 year
Secondary outcomes (2)
Entry into active phase (dilation to 5-6 cm)
Rate of entry into active phase (dilation to 5-6 cm)
Measured: 1 year
Complication
Complication rate = composite criteria including :
- Hypercinesia / hypertonia rate
- Rate of fetal heart rate anomalies
- Fever rate during work
- Rate of uterine ruptures
- Postpartum hemorrhage rate
- Rate of infectious complications in immediate postpartum (fever> 38.5 ° or wall abscess or endometritis defined by a fever greater than 38 ° with pain in uterine mobilization and foul or foul-smelling lochia)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start11 Jun 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Other
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Nord Franche-Comte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299854
- Sponsor's protocol ID
- P/2019/469
- Acronym
- MODOBAT
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2020
- Last updated
- 3 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)
- ClinicalTrials.gov ID
- NCT04299854
- Acronym / sponsor ID
- MODOBAT / P/2019/469
- Conditions
- Induction of Labor Affected Fetus / Newborn, Obese
- Keywords
- Induction of Labor, BMI, Obesity, caesarean, C-section, Pregnancy, Balloon, Dinoprostone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Hopital Nord Franche-Comte
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 9 Mar 2020 (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.
In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.
Detailed description
Obesity has for several decades become a global epidemic in developed countries. In case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. Unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. However, in this context effectiveness of each mode of induction is not known. Some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis.
The aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon Foley catheter arm will be included prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Dinoprostone | – | Drug: Dinoprostone 10mgInduction of labor by 10mg of vaginal dinoprostone |
| Single Balloon Foley Catheter | – | Device: single balloon Foley catheterInduction of labor by single balloon Foley catheter |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients of the level III maternity of university hospital center of Besançon and level IIB maternity of regional hospital of Trevenans, France.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Medical indication of induction of labor
- BMI ≥ 30 kg / m2
- Bishop < 6
- Singleton
Key exclusion criteria (3 listed)
- Adults under guardianship or curatorship
- Scarred uterus
- Placenta praevia
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 |
|---|---|---|
| Dinoprostone 10mgVaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina | Drug | Vaginal Dinoprostone |
| single balloon Foley catheterA single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os | Device | Single Balloon Foley Catheter |
Primary outcome
Cesarean sections
Time frame: 1 year
Rate of cesarean sections in each group
2 secondary outcomes
Entry into active phase (dilation to 5-6 cm)
Time frame: 1 year
Complication
Time frame: 1 year
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 3 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Induction of Labor Affected Fetus / Newborn and Obese, run by Centre Hospitalier Universitaire de Besancon 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 7 inclusion and 3 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 3 May 2021. 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?
Cesarean sections (time frame: 1 year). 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 3 May 2021.