Vaginal DeliveryPhase 4SOFTNESNCT01190163
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
A Phase 4 study testing Dinoprostone and Oxytocin in people with Vaginal Delivery and Cesarean Section, run by Ferring Pharmaceuticals at 4 sites in Brazil.
Trial summary
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Delivery, Cesarean Section
- What is being tested?
- Dinoprostone and Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 4 sitesBrazil
- Study dates
- Jun 2010to Jan 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Gestational age ≥ 38 weeks
- Fetal cephalic presentation
- Bishop score < 6
Who cannot join
- No uterine scar (no previous delivery by caesarean section)
- No more than 3 previous vaginal births
- No condition that disallows use of prostaglandins for induction of labor
- Premature rupture of the membranes
- Oligohydramnios
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo
Hospital Municipal Universitário - Faculdade de Medicina do ABC
São Bernardo do Campo, São Paulo
Hospital M Boi Mirim
São Paulo, São Paulo
Hospital Maternidade Leonor Mendes de Barros
São Paulo, São Paulo
About this study
Official title: Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
- Conditions
- Vaginal Delivery, Cesarean Section
- Being tested
- Dinoprostone, Oxytocin
- Keywords
- Vaginal Birth delivery within 24 hours and C-section rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Dinoprostone |
| B | Active comparator | Not described Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal birth delivery within 24 hours and C-section rate
Measured: 24 hours
Secondary outcomes (3)
Treatment failure rate
Measured: 24 hours
Uterine hyperstimulation and/or fetal distress
Measured: 24 hours
Use of additional oxytocin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study was early terminated due to problems enrolling adequate number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190163
- Sponsor's protocol ID
- FE999901 CS01
- Acronym
- SOFTNES
- Status last verified
- Aug 2012
- First submitted
- 26 Aug 2010
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor
- ClinicalTrials.gov ID
- NCT01190163
- Acronym / sponsor ID
- SOFTNES / FE999901 CS01
- Conditions
- Vaginal Delivery, Cesarean Section
- Keywords
- Vaginal Birth delivery within 24 hours and C-section rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was early terminated due to problems enrolling adequate number of patients
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Aug 2010 (estimated)
- 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.
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Dinoprostone |
| B | Active comparator | Drug: Oxytocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Gestational age ≥ 38 weeks
- Fetal cephalic presentation
- Bishop score < 6
Key exclusion criteria (5 listed)
- No uterine scar (no previous delivery by caesarean section)
- No more than 3 previous vaginal births
- No condition that disallows use of prostaglandins for induction of labor
- Premature rupture of the membranes
- Oligohydramnios
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 | Drug | A |
| Oxytocin | Drug | B |
Primary outcome
Vaginal birth delivery within 24 hours and C-section rate
Time frame: 24 hours
3 secondary outcomes
Treatment failure rate
Time frame: 24 hours
Uterine hyperstimulation and/or fetal distress
Time frame: 24 hours
Use of additional oxytocin
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Study was early terminated due to problems enrolling adequate number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinoprostone and Oxytocin in people with Vaginal Delivery and Cesarean Section, run by Ferring Pharmaceuticals at 4 sites in Brazil.
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: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was early terminated due to problems enrolling adequate number of patients). Results are not available in the source record.
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?
Vaginal birth delivery within 24 hours and C-section rate (time frame: 24 hours). 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 23 Aug 2012.