Cervical RipeningPhase 2NCT00828711
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
A Phase 2 study testing MVI 100, MVI 150 and MVI 200 in people with Cervical Ripening and Induction of Labor, run by Ferring Pharmaceuticals at 11 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Ripening, Induction of Labor
- What is being tested?
- MVI 100, MVI 150 and MVI 200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide written informed consent;
- Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
- Women aged 18 years or older;
- Candidate for pharmacologic induction of labor;
- Single, live vertex fetus;
- Baseline modified Bishop score ≤ 4;
- Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
- Body Mass Index (BMI) ≤ 50 at the time of entry to the study.
Who cannot join
- Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
- Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
- Fetal malpresentation;
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- Diagnosed fetal abnormalities;
- Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
- Ruptured membranes ≥ 48 hours prior to the start of treatment;
- Suspected chorioamnionitis;
- Fever (oral or aural temperature > 37.5˚C);
- Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
- Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
- Any condition urgently requiring delivery;
- Unable to comply with the protocol.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of New Mexico Medical Center
Albuquerque, New Mexico, 87131
Duke University Medical Center
Durham, North Carolina, 27710
Greenville Hospital System
Greenville, South Carolina, 29605
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
University of Tennesse Medical Center
Knoxville, Tennessee, 37920
Long Beach Memorial Medical Center
Long Beach, California, 90806
UCI Medical Center
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Precision Trials
Phoenix, Arizona, 85032
Tuscon Medical Center
Tucson, Arizona, 85716
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.
- Conditions
- Cervical Ripening, Induction of Labor
- Being tested
- MVI 100, MVI 150, MVI 200
- Keywords
- Misoprostol vaginal insert, Induction of labor, Cervical ripening, Rate of cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVI 100Drug
Also called Misopess (TM), Misodel (R)
Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
MVI 150Drug
Also called Misopess (TM), Misodel (R)
Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
MVI 200Drug
Also called Misopess (TM), Misodel (R)
Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
| Study group | Role | What they receive |
|---|---|---|
| MVI 100 | Experimental | MVI 100 mcg vaginal insert Receives: Drug: MVI 100 |
| MVI 150 | Experimental | MVI 150 mcg vaginal insert Receives: Drug: MVI 150 |
| MVI 200 | Experimental | MVI 200 mcg vaginal insert Receives: Drug: MVI 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Women Delivering Vaginally
Measured: Interval from study drug administration to 24 hours
Secondary outcomes (7)
Time to Vaginal Delivery
Measured: Interval from study drug administration to delivery (average 24 hours)
Rate of Adverse Events
All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.
Measured: From study drug administration to hospital discharge (approximately 48 - 72 hours)
Proportion of Cesarean Delivery
Measured: Interval from study drug administration to cesarean delivery (average 24 hours)
Cervical Ripening Using Composite Measure of Success
Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:
- Increase from baseline in modified Bishop score ≥3; or
- Achievement of modified Bishop score of ≥6; or
- Vaginal delivery.
Measured: 12 hours after insertion of drug
Use of Oxytocin
Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.
Measured: At least 30 minutes after study drug removal
Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.
The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.
Measured: From study drug insertion up to 2 hours post study drug removal
Time to Onset of Active Labor
Measured: Interval from study drug administration to active labor (average 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RipeningStudies 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
- 374 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
- NCT00828711
- Sponsor's protocol ID
- Miso-Obs-204
- Status last verified
- Mar 2014
- First submitted
- 22 Jan 2009
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wing DA, Miller H, Parker L, Powers BL, Rayburn WF; Misoprostol Vaginal Insert Miso-Obs-204 Investigators. Misoprostol vaginal insert for successful labor induction: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):533-541. doi: 10.1097/AOG.0b013e318209d669.
PubMed 21343755
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Dose-Ranging, Phase II Study to Assess the Efficacy and Safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert for Women Requiring Cervical Ripening and Induction of Labor
- ClinicalTrials.gov ID
- NCT00828711
- Acronym / sponsor ID
- Miso-Obs-204
- Conditions
- Cervical Ripening, Induction of Labor
- Keywords
- Misoprostol vaginal insert, Induction of labor, Cervical ripening, Rate of cesarean section
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MVI 100 | Experimental | Drug: MVI 100MVI 100 mcg vaginal insert |
| MVI 150 | Experimental | Drug: MVI 150MVI 150 mcg vaginal insert |
| MVI 200 | Experimental | Drug: MVI 200MVI 200 mcg vaginal insert |
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)
- Provide written informed consent;
- Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
- Women aged 18 years or older;
- Candidate for pharmacologic induction of labor;
- Single, live vertex fetus;
Key exclusion criteria (15 listed)
- Nulliparous women participating in the pharmacokinetic (PK) arm of the study: women with hemoglobin level < 11.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
- Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
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 |
|---|---|---|
| MVI 100Also: Misopess (TM), Misodel (R)Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | Drug | MVI 100 |
| MVI 150Also: Misopess (TM), Misodel (R)Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | Drug | MVI 150 |
| MVI 200Also: Misopess (TM), Misodel (R)Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. | Drug | MVI 200 |
Primary outcome
Proportion of Women Delivering Vaginally
Time frame: Interval from study drug administration to 24 hours
7 secondary outcomes
Time to Vaginal Delivery
Time frame: Interval from study drug administration to delivery (average 24 hours)
Rate of Adverse Events
Time frame: From study drug administration to hospital discharge (approximately 48 - 72 hours)
Proportion of Cesarean Delivery
Time frame: Interval from study drug administration to cesarean delivery (average 24 hours)
Cervical Ripening Using Composite Measure of Success
Time frame: 12 hours after insertion of drug
Use of Oxytocin
Time frame: At least 30 minutes after study drug removal
Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.
Time frame: From study drug insertion up to 2 hours post study drug removal
Time to Onset of Active Labor
Time frame: Interval from study drug administration to active labor (average 12 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21343755Wing DA, Miller H, Parker L, Powers BL, Rayburn WF; Misoprostol Vaginal Insert Miso-Obs-204 Investigators. Misoprostol vaginal insert for successful labor induction: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):533-541. doi: 10.1097/AOG.0b013e318209d669.
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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
11 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 MVI 100, MVI 150 and MVI 200 in people with Cervical Ripening and Induction of Labor, run by Ferring Pharmaceuticals at 11 sites in United States.
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 15 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Women Delivering Vaginally (time frame: Interval from study drug administration to 24 hours). 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 NCT00828711, which also lists 1 linked publication.
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 21 Apr 2014.