Labor, InducedPhase 4NCT00843362
24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction
A Phase 4 study testing Dinoprostone vaginal pessary and Dinoprostone vaginal gel in people with Labor, Induced and Cervical Ripening, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Induced, Cervical Ripening
- What is being tested?
- Dinoprostone vaginal pessary and Dinoprostone vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to Jun 2008
- 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, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks
Who cannot join
- premature rupture of the membranes, history of a previous caesarean section,
- maternal clinical contraindications to the administration of prostaglandins,
- fetal malpresentation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynaecology, University of Brescia
Brescia, 25123
About this study
Official title: A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4
The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.
- Conditions
- Labor, Induced, Cervical Ripening
- Being tested
- Dinoprostone vaginal pessary, Dinoprostone vaginal gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone vaginal pessaryDrug
Also called Propess, Ferring, Milan, Italy
10 mg controlled-release dinoprostone pessary applied for 24 hours
Dinoprostone vaginal gelDrug
Also called Prepidil, Pharmacia, Milan, Italy
2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 24-hours vaginal dinoprostone pessary Receives: Drug: Dinoprostone vaginal pessary |
| 2 | Active comparator | Vaginal dinoprostone gel Receives: Drug: Dinoprostone vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
spontaneous vaginal delivery
Secondary outcomes (8)
induction to labour time
induction to delivery time
rate of failed induction
cost per patient
rate of caesarean section for fetal heart rate abnormalities
5 minute Apgar score < 7
arterial cord blood pH <7.1
uterine hyperstimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843362
- Sponsor's protocol ID
- Spedali Civili 924
- Status last verified
- Feb 2009
- First submitted
- 12 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4
- ClinicalTrials.gov ID
- NCT00843362
- Acronym / sponsor ID
- Spedali Civili 924
- Conditions
- Labor, Induced, Cervical Ripening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Feb 2009 (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.
The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dinoprostone vaginal pessary24-hours vaginal dinoprostone pessary |
| 2 | Active comparator | Drug: Dinoprostone vaginal gelVaginal dinoprostone gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks
Key exclusion criteria (3 listed)
- premature rupture of the membranes, history of a previous caesarean section,
- maternal clinical contraindications to the administration of prostaglandins,
- fetal malpresentation
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 vaginal pessaryAlso: Propess, Ferring, Milan, Italy10 mg controlled-release dinoprostone pessary applied for 24 hours | Drug | 1 |
| Dinoprostone vaginal gelAlso: Prepidil, Pharmacia, Milan, Italy2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval | Drug | 2 |
Primary outcome
spontaneous vaginal delivery
8 secondary outcomes
induction to labour time
induction to delivery time
rate of failed induction
cost per patient
rate of caesarean section for fetal heart rate abnormalities
5 minute Apgar score < 7
arterial cord blood pH <7.1
uterine hyperstimulation
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 13 Feb 2009.
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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.
1 site 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 vaginal pessary and Dinoprostone vaginal gel in people with Labor, Induced and Cervical Ripening, run by Università degli Studi di Brescia at 1 site in Italy.
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 1 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 13 Feb 2009. 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 Italy. 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 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?
spontaneous vaginal delivery. 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 13 Feb 2009.