Cervical RipeningPhase 3NCT00308711
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
A Phase 3 study testing Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg and Dinoprostone vaginal insert (Cervidil) in people with Cervical Ripening and Labor, Induced, run by Ferring Pharmaceuticals at 52 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing 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, Labor, Induced
- What is being tested?
- Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg and Dinoprostone vaginal insert (Cervidil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,308 participants
- Where
- 52 sitesin 2 countries
- Study dates
- Apr 2006to Aug 2007
- Phase
- Phase 3
- 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
- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
Who cannot join
- No uterine scar (no previous delivery by cesarean section)
- No multiple gestation
- No condition that disallows use of prostaglandins for induction of labor
- No more than 3 previous vaginal births beyond 24 weeks gestation
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
United States49 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19090
University of New Mexico Medical Center
Albuquerque, New Mexico, 87131
Lehigh Valley Medical Center
Allentown, Pennsylvania, 18103
Northside Hospital
Alpharetta, Georgia, 30005
Overlake Hospital Medical Center
Bellevue, Washington, 98004
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35249
Erlanger Hospital
Chattanooga, Tennessee, 37403
University of Cincinnati Holmes Hospital
Cincinnati, Ohio, 45267
Ohio State University Medical Center
Columbus, Ohio, 43210
Methodist Charlton Medical Center
Dallas, Texas, 75327
Miami Valley Hospital
Dayton, Ohio, 45409
Hurley Medical Center
Flint, Michigan, 48503
Greenville Hospital System
Greenville, South Carolina, 29605
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
United Health Services Hospitals, Inc.
Johnson City, New York, 13790
University of Tennesse Medical Center
Knoxville, Tennessee, 37920
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Long Beach Memorial Medical Center
Long Beach, California, 90806
Baptist Memorial Hospital
Memphis, Tennessee, 38119
Banner Desert Medical Center
Mesa, Arizona, 85202
Winthrop-South Nassau University Health Center
Mineola, New York, 11501
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Morristown Memorial Hospital
Morristown, New Jersey, 07962
NYU School of Medicine
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Christiana Care Health System
Newark, Delaware, 19718
Trident Health System
North Charleston, South Carolina, 29406
McKay-Dee Hospital
Ogden, Utah, 84403
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UCI Medical Center
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Maricopa Medical Center
Phoenix, Arizona, 85008
Arizona Wellness Center for Women
Phoenix, Arizona, 85032
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Legacy Center for Maternal-Fetal Medicine
Portland, Oregon, 97232
St. Mark's Hospital
Salt Lake City, Utah, 84124
University of Utah Health Science Center
Salt Lake City, Utah, 84132
Santa Clara Valley Medical Center
San Jose, California, 95128
Bayfront Medical Center
St. Petersburg, Florida, 33701
University of Florida Health Sciences Center
Tampa, Florida, 33606
Kings Daughters Clinic
Temple, Texas, 76502
Jacobi Medical Center
The Bronx, New York, 10461
Tuscon Medical Center
Tucson, Arizona, 85716
Jordan Valley Hospital
West Jordan, Utah, 84088
St. Mary's Medical Center
West Palm Beach, Florida, 33401
Pioneer Valley Hospital
West Valley City, Utah, 84120
Saint Clare's Hospital
Weston, Wisconsin, 54476
Women's Health Alliance
Winston-Salem, North Carolina, 27103
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Canada3 sites
IWK Health Centre and Dalhousie University
Halifax, Nova Scotia, B3K 6R8
University of Saskatchewan Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Women's Health Centre/General Hospital/Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: A Multi-center, Randomized, Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Read the detailed description
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.
Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.
- Conditions
- Cervical Ripening, Labor, Induced
- Being tested
- Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg, Dinoprostone vaginal insert (Cervidil)
- Keywords
- Cervical ripening, Induction of labor, Dinoprostone vaginal insert, Cervidil, Misoprostol vaginal insert, Modified Bishop's Score, PGE2, PGE1, Uterine Hyperstimulation, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol vaginal insert 100 mcgDrug
Also called Misopess(TM)
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Misoprostol vaginal insert 50 mcgDrug
Also called Misopess(TM)
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
Dinoprostone vaginal insert (Cervidil)Drug
Also called Propess(R), 10 mg dinoprostone vaginal insert
Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h.
| Study group | Role | What they receive |
|---|---|---|
| MVI 100 | Experimental | Misoprostol vaginal insert 100 mcg over 24h Receives: Drug: Misoprostol vaginal insert 100 mcg |
| MVI 50 | Experimental | Misoprostol vaginal insert 50 mcg over 24h Receives: Drug: Misoprostol vaginal insert 50 mcg |
| Cervidil 10 mg vaginal insert | Active comparator | Cervidil 10 mg over 24h Receives: Drug: Dinoprostone vaginal insert (Cervidil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes From Drug Insertion to Vaginal Delivery
Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.
Measured: 2880 minutes
Percentage of Participants With a Cesarean Section Delivery
Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.
Measured: 2880 minutes
Secondary outcomes (7)
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events
This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods.
Measured: 96 hours
Percentage of Participants With Pre-Delivery Oxytocin Use
Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.
Measured: 2880 minutes
Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert
Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.
Measured: 12 hours
Minutes to Onset of Active Labor
Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.
Measured: 2880 minutes
Minutes to Rupture of Membranes (ROM)
Interval from study drug insertion to ROM.
Measured: 2880 minutes
Duration of Stay in Minutes in Labor and Delivery Suite
Minutes in Labor and Delivery (L \& D) suite starting from insertion of the study drug to discharge from L \& D to post partum care.
Measured: 5760 minuts
Days in Hospital for Mother and Neonate
Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2007
- Study completionAug 2007
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 (7)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Colquhoun, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308711
- Sponsor's protocol ID
- Miso-Obs-004
- Status last verified
- Jun 2012
- First submitted
- 27 Mar 2006
- Last updated
- 25 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 17077234Wing DA; Misoprostol Vaginal Insert Consortium. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):801-12. doi: 10.1097/AOG.0b013e318187042e.
PubMed 18827122Pevzner L, Rayburn WF, Rumney P, Wing DA. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009 Aug;114(2 Pt 1):261-267. doi: 10.1097/AOG.0b013e3181ad9377.
PubMed 19622986Hawkins JS, Stephenson M, Powers B, Wing DA. Diabetes mellitus: an independent predictor of duration of prostaglandin labor induction. J Perinatol. 2017 May;37(5):488-491. doi: 10.1038/jp.2016.270. Epub 2017 Jan 26.
PubMed 28125096Brennan MC, Pevzner L, Wing DA, Powers BL, Rayburn WF. Retention of dinoprostone vaginal insert beyond 12 hours for induction of labor. Am J Perinatol. 2011 Jun;28(6):479-84. doi: 10.1055/s-0030-1271208. Epub 2011 Jan 11.
PubMed 21225563
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).
- ClinicalTrials.gov ID
- NCT00308711
- Acronym / sponsor ID
- Miso-Obs-004
- Conditions
- Cervical Ripening, Labor, Induced
- Keywords
- Cervical ripening, Induction of labor, Dinoprostone vaginal insert, Cervidil, Misoprostol vaginal insert, Modified Bishop's Score, PGE2, PGE1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,308 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Mar 2006 (estimated)
- Results
- Posted 19 Feb 2010
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 determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Detailed description
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.
Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.
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: Misoprostol vaginal insert 100 mcgMisoprostol vaginal insert 100 mcg over 24h |
| MVI 50 | Experimental | Drug: Misoprostol vaginal insert 50 mcgMisoprostol vaginal insert 50 mcg over 24h |
| Cervidil 10 mg vaginal insert | Active comparator | Drug: Dinoprostone vaginal insert (Cervidil)Cervidil 10 mg over 24h |
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)
- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
Key exclusion criteria (4 listed)
- No uterine scar (no previous delivery by cesarean section)
- No multiple gestation
- No condition that disallows use of prostaglandins for induction of labor
- No more than 3 previous vaginal births beyond 24 weeks gestation
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 100 mcgAlso: Misopess(TM)Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. | Drug | MVI 100 |
| Misoprostol vaginal insert 50 mcgAlso: Misopess(TM)Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. | Drug | MVI 50 |
| Dinoprostone vaginal insert (Cervidil)Also: Propess(R), 10 mg dinoprostone vaginal insertHydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to meeting one of the first two criteria. In no case is the insert to remain in place longer than 24h. | Drug | Cervidil 10 mg vaginal insert |
Primary outcome
Minutes From Drug Insertion to Vaginal Delivery
Time frame: 2880 minutes
Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.
Percentage of Participants With a Cesarean Section Delivery
Time frame: 2880 minutes
Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.
7 secondary outcomes
Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events
Time frame: 96 hours
Percentage of Participants With Pre-Delivery Oxytocin Use
Time frame: 2880 minutes
Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert
Time frame: 12 hours
Minutes to Onset of Active Labor
Time frame: 2880 minutes
Minutes to Rupture of Membranes (ROM)
Time frame: 2880 minutes
Duration of Stay in Minutes in Labor and Delivery Suite
Time frame: 5760 minuts
Days in Hospital for Mother and Neonate
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: 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.
- Results publication: PubMed 18827122Wing DA; Misoprostol Vaginal Insert Consortium. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):801-12. doi: 10.1097/AOG.0b013e318187042e.
- Results publication: PubMed 19622986Pevzner L, Rayburn WF, Rumney P, Wing DA. Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. Obstet Gynecol. 2009 Aug;114(2 Pt 1):261-267. doi: 10.1097/AOG.0b013e3181ad9377.
- Derived from this study: PubMed 28125096Hawkins JS, Stephenson M, Powers B, Wing DA. Diabetes mellitus: an independent predictor of duration of prostaglandin labor induction. J Perinatol. 2017 May;37(5):488-491. doi: 10.1038/jp.2016.270. Epub 2017 Jan 26.
- Derived from this study: PubMed 21225563Brennan MC, Pevzner L, Wing DA, Powers BL, Rayburn WF. Retention of dinoprostone vaginal insert beyond 12 hours for induction of labor. Am J Perinatol. 2011 Jun;28(6):479-84. doi: 10.1055/s-0030-1271208. Epub 2011 Jan 11.
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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
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg and Dinoprostone vaginal insert (Cervidil) in people with Cervical Ripening and Labor, Induced, run by Ferring Pharmaceuticals at 52 sites in 2 countries.
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 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 25 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 52 sites in United States, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Feb 2010). 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?
Minutes From Drug Insertion to Vaginal Delivery (time frame: 2880 minutes). The study lists 2 primary outcomes in all. 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 NCT00308711, which also lists 7 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 25 Jun 2012.