Labor InductionPhase 2NCT00346840
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
A Phase 2 study testing Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg and Misoprostol vaginal insert 100 mcg in people with Labor Induction and Cervical Ripening, run by Ferring Pharmaceuticals at 6 sites in United Kingdom.
Trial summary
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Induction, Cervical Ripening
- What is being tested?
- Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg and Misoprostol vaginal insert 100 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Jun 2003to Mar 2004
- Phase
- Phase 2
- 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
- At term (37 to 42 weeks inclusive gestation).
- Aged 18 years or older.
- One previous full term delivery (at least 37 weeks gestation).
- Singleton pregnancy.
- Cephalic presentation (normal lie).
- Bishop score more than 6 as determined by MBS criteria.
- Uncomplicated pregnancy as judged by the physician.
- Written informed consent.
Who cannot join
- four previous full term deliveries.
- Previous uterine surgery, including C-section and surgery to the cervix of the uterus (cone biopsy of the cervix is permitted).
- In spontaneous labour.
- Administration of oxytocin or a tocolytic drug or any other cervical ripening or labour inducing agent prior to enrolment (within seven days of enrolment).
- Suspected cephalo-pelvic disproportion.
- Evidence or suggestion of fetal distress.
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- Subject has received NSAID (including aspirin) within four hours of study treatment (topical is permitted).
- Pyrexia (oral or aural temperature > 37.5C).
- Unexplained genital bleeding during this pregnancy after 24 weeks.
- Current pelvic inflammatory disease, unless adequate prior treatment has been instituted.
- Placenta praevia.
- Known or suspected allergy to misoprostol or other prostaglandins.
- Prior serious adverse event related to prostaglandin administered by any route for any indication.
- Subject unable to comply with the requirements of the protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Birmingham Women's Hospital
Birmingham, B13 9HP
Princess Royal Maternity Hospital
Glasgow, G11 5DY
King George Hospital
Ilford, IG3 8YB
Liverpool Women's Hospital
Liverpool, L8 7SS
Northampton General Hospital
Northampton, NN1 5BD
The Queen's Mother's Hospital
Yorkhill, Glasgow, G12 9TZ
About this study
Official title: Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
Read the detailed description
Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA.
Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol.
This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.
- Conditions
- Labor Induction, Cervical Ripening
- Being tested
- Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg, Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 200 mcg
- Keywords
- Labor induction, cervical ripening, misoprostol, vaginal insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol vaginal insert 25 mcgDrug
Also called Misoprostol vaginal insert
One hydrogel polymer vaginal insert for up to 24h
Misoprostol vaginal insert 50 mcgDrug
Also called Misoprostol vaginal insert
One hydrogel polymer vaginal insert for up to 24h
Misoprostol vaginal insert 100 mcgDrug
Also called Misoprostol vaginal insert
One hydrogel polymer vaginal insert for up to 24h
Misoprostol vaginal insert 200 mcgDrug
Also called Misoprostol vaginal insert
One hydrogel polymer vaginal insert for up to 24h
| Study group | Role | What they receive |
|---|---|---|
| MVI 25 | Experimental | Misoprostol vaginal insert 25 mcg Receives: Drug: Misoprostol vaginal insert 25 mcg |
| MVI 50 | Experimental | Misoprostol vaginal insert 50 mcg Receives: Drug: Misoprostol vaginal insert 50 mcg |
| MVI 100 | Experimental | Misoprostol vaginal insert 100 mcg Receives: Drug: Misoprostol vaginal insert 100 mcg |
| MVI 200 | Experimental | Misoprostol vaginal insert 200 mcg Receives: Drug: Misoprostol vaginal insert 200 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to vaginal delivery.
Measured: From insertion of study drug to neonate delivery
Secondary outcomes (5)
uterine hyperstimulation
Measured: From insertion of study drug to neonate delivery
safety in terms of maternal, fetal and neonatal adverse events
Measured: From insertion of study drug to neonate delivery
Success on composite modified Bishop score (MBS)at 12 hours after drug insertion
Measured: From insertion of study drug to 12 hours
frequency and amount of oxytocin use
Measured: From insertion of study drug to neonate delivery
drug release characteristics in terms of residual concentrations
Measured: From insertion of study drug to removal of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJun 2003
- Primary completionFeb 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Colquhoun, MD, Study director, Pleiad, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346840
- Sponsor's protocol ID
- Miso-Obs-002
- Status last verified
- Jun 2012
- First submitted
- 29 Jun 2006
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Castaneda CS, Izquierdo Puente JC, Leon Ochoa RA, Plasse TF, Powers BL, Rayburn WF. Misoprostol dose selection in a controlled-release vaginal insert for induction of labor in nulliparous women. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1071-5. doi: 10.1016/j.ajog.2005.06.072.
PubMed 16157114Rayburn WF, Powers BL, Plasse TF, Carr D, Di Spirito M. Pharmacokinetics of a controlled-release misoprostol vaginal insert at term. J Soc Gynecol Investig. 2006 Feb;13(2):112-7. doi: 10.1016/j.jsgi.2005.10.004.
PubMed 16443504Ewert K, Powers B, Robertson S, Alfirevic Z. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1130-7. doi: 10.1097/01.AOG.0000239100.16166.5a.
PubMed 17077234
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial
- ClinicalTrials.gov ID
- NCT00346840
- Acronym / sponsor ID
- Miso-Obs-002
- Conditions
- Labor Induction, Cervical Ripening
- Keywords
- Labor induction, cervical ripening, misoprostol, vaginal insert
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 30 Jun 2006 (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 primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
Detailed description
Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA.
Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol.
This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MVI 25 | Experimental | Drug: Misoprostol vaginal insert 25 mcgMisoprostol vaginal insert 25 mcg |
| MVI 50 | Experimental | Drug: Misoprostol vaginal insert 50 mcgMisoprostol vaginal insert 50 mcg |
| MVI 100 | Experimental | Drug: Misoprostol vaginal insert 100 mcgMisoprostol vaginal insert 100 mcg |
| MVI 200 | Experimental | Drug: Misoprostol vaginal insert 200 mcgMisoprostol vaginal insert 200 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At term (37 to 42 weeks inclusive gestation).
- Aged 18 years or older.
- One previous full term delivery (at least 37 weeks gestation).
- Singleton pregnancy.
- Cephalic presentation (normal lie).
Key exclusion criteria (14 listed)
- four previous full term deliveries.
- Previous uterine surgery, including C-section and surgery to the cervix of the uterus (cone biopsy of the cervix is permitted).
- In spontaneous labour.
- Administration of oxytocin or a tocolytic drug or any other cervical ripening or labour inducing agent prior to enrolment (within seven days of enrolment).
- Suspected cephalo-pelvic disproportion.
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 |
|---|---|---|
| Misoprostol vaginal insert 25 mcgAlso: Misoprostol vaginal insertOne hydrogel polymer vaginal insert for up to 24h | Drug | MVI 25 |
| Misoprostol vaginal insert 50 mcgAlso: Misoprostol vaginal insertOne hydrogel polymer vaginal insert for up to 24h | Drug | MVI 50 |
| Misoprostol vaginal insert 100 mcgAlso: Misoprostol vaginal insertOne hydrogel polymer vaginal insert for up to 24h | Drug | MVI 100 |
| Misoprostol vaginal insert 200 mcgAlso: Misoprostol vaginal insertOne hydrogel polymer vaginal insert for up to 24h | Drug | MVI 200 |
Primary outcome
Time to vaginal delivery.
Time frame: From insertion of study drug to neonate delivery
5 secondary outcomes
uterine hyperstimulation
Time frame: From insertion of study drug to neonate delivery
safety in terms of maternal, fetal and neonatal adverse events
Time frame: From insertion of study drug to neonate delivery
Success on composite modified Bishop score (MBS)at 12 hours after drug insertion
Time frame: From insertion of study drug to 12 hours
frequency and amount of oxytocin use
Time frame: From insertion of study drug to neonate delivery
drug release characteristics in terms of residual concentrations
Time frame: From insertion of study drug to removal of study drug
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 18 Jun 2012.
- Background: PubMed 16157114Castaneda CS, Izquierdo Puente JC, Leon Ochoa RA, Plasse TF, Powers BL, Rayburn WF. Misoprostol dose selection in a controlled-release vaginal insert for induction of labor in nulliparous women. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 2):1071-5. doi: 10.1016/j.ajog.2005.06.072.
- Background: PubMed 16443504Rayburn WF, Powers BL, Plasse TF, Carr D, Di Spirito M. Pharmacokinetics of a controlled-release misoprostol vaginal insert at term. J Soc Gynecol Investig. 2006 Feb;13(2):112-7. doi: 10.1016/j.jsgi.2005.10.004.
- Results publication: PubMed 17077234Ewert K, Powers B, Robertson S, Alfirevic Z. Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1130-7. doi: 10.1097/01.AOG.0000239100.16166.5a.
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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.
Helen Colquhoun, MD study director
Pleiad, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg and Misoprostol vaginal insert 100 mcg in people with Labor Induction and Cervical Ripening, run by Ferring Pharmaceuticals at 6 sites in United Kingdom.
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 8 inclusion and 14 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 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to vaginal delivery. (time frame: From insertion of study drug to neonate 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 NCT00346840, which also lists 3 linked publications.
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 18 Jun 2012.