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ObesityNCT01962831

Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

A study testing Dinoprostone and Single balloon foley catheter in people with Obesity and Pregnancy, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.

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

The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Pregnancy, Labor, Induced
What is being tested?
Dinoprostone and Single balloon foley catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteCanada
Study dates
Oct 2013to Jun 2016
Phase
Interventional
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

Who may be able to join

  • Obese (BMI >30 before 20 weeks gestational age)
  • Singleton pregnancy
  • Vertex presentation
  • Bishop Score <6
  • Intact membranes
  • Gestational age 37+0 to 42+0
  • Normal fetal heart tracing on admission for ripening

Who cannot join

  • Induction of labour for intrauterine fetal demise
  • Intrauterine growth restriction
  • Suspected abruption at the start of induction
  • Any contraindication for a vaginal delivery

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Regina Qu'Appelle Health Region

    Regina, Saskatchewan, S4P0W5

Other trials in Canada

About this study

Official title: Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30

The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.

Being tested
Dinoprostone, Single balloon foley catheter
Keywords
obesity, labor, induced, pregnancy, cervical ripening, dinoprostone
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DinoprostoneDrug

    Also called Cervidil

  • Single balloon foley catheterDevice

Study groups in NCT01962831
Study groupRoleWhat they receive
dinoprostoneExperimentalGroup of women that will receive dinoprostone for induction of labour dinoprostone 10 mg in vagina to be reassessed every 24 hours
Receives: Drug: Dinoprostone
Single balloon foley catheterExperimentalGroup of women that will have a single balloon foley catheter inserted for induction of labour
Receives: Device: Single balloon foley catheter

What is being measured

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

  1. Time(hours) from initiation of induction of labour to vaginal delivery

    Measured: Will be assessed at the end of each vaginal delivery

Secondary outcomes (9)

  1. Number of vaginal deliveries within 24 hours in each group

    Measured: 2 years

  2. Number of cesarean sections in each group

    Measured: 2 years

  3. Number of operative vaginal deliveries in each group

    Measured: 2 years

  4. Number of chorioamnionitis cases in each group

    Measured: 2 years

  5. Number of patients that required oxytocin administration in each group

    Measured: 2 years

  6. Number of patients that required an epidural in each group

    Measured: 2 years

  7. Number of babies that required neonatal intensive care unit (NICU) admission in each group

    Measured: 2 years

  8. Number of babies that had an arterial pH <7 in each group

    Measured: 2 years

  9. Number of babies that had an APGAR score <7 at 5 minutes

    Measured: 2 years

Timeline

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

  1. First posted14 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962831
Sponsor's protocol ID
REB-13-51
Status last verified
Oct 2016
First submitted
19 Sep 2013
Last updated
13 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Dinoprostone and Single balloon foley catheter in people with Obesity and Pregnancy, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.

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 4 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 Oct 2016. 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 Canada. 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?

Time(hours) from initiation of induction of labour to vaginal delivery (time frame: Will be assessed at the end of each vaginal delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962831.

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 Oct 2016.

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