Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour - Full Text View

Sponsor:	Cytokine PharmaSciences
Information provided by:	Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00346840

Purpose

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.

Condition	Intervention	Phase
Labor Induction Cervical Ripening	Drug: Misoprostol vaginal insert 25 mcg Drug: Misoprostol vaginal insert 50 mcg Drug: Misoprostol vaginal insert 100 mcg Drug: Misoprostol vaginal insert 200 mcg	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Controlled-Release Misoprostol Vaginal Insert in Parous Women for Labor Induction: Randomized Trial

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by Cytokine PharmaSciences:

Primary Outcome Measures:

Time to vaginal delivery. [ Time Frame: From insertion of study drug to neonate delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

uterine hyperstimulation [ Time Frame: From insertion of study drug to neonate delivery ] [ Designated as safety issue: Yes ]
safety in terms of maternal, fetal and neonatal adverse events [ Time Frame: From insertion of study drug to neonate delivery ] [ Designated as safety issue: Yes ]
Success on composite modified Bishop score (MBS)at 12 hours after drug insertion [ Time Frame: From insertion of study drug to 12 hours ] [ Designated as safety issue: No ]
frequency and amount of oxytocin use [ Time Frame: From insertion of study drug to neonate delivery ] [ Designated as safety issue: No ]
drug release characteristics in terms of residual concentrations [ Time Frame: From insertion of study drug to removal of study drug ] [ Designated as safety issue: No ]

Enrollment:	124
Study Start Date:	June 2003
Study Completion Date:	March 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MVI 25 Misoprostol vaginal insert 25 mcg	Drug: Misoprostol vaginal insert 25 mcg One hydrogel polymer vaginal insert for up to 24h Other Name: Misoprostol vaginal insert
Experimental: MVI 50 Misoprostol vaginal insert 50 mcg	Drug: Misoprostol vaginal insert 50 mcg One hydrogel polymer vaginal insert for up to 24h Other Name: Misoprostol vaginal insert
Experimental: MVI 100 Misoprostol vaginal insert 100 mcg	Drug: Misoprostol vaginal insert 100 mcg One hydrogel polymer vaginal insert for up to 24h Other Name: Misoprostol vaginal insert
Experimental: MVI 200 Misoprostol vaginal insert 200 mcg	Drug: Misoprostol vaginal insert 200 mcg One hydrogel polymer vaginal insert for up to 24h Other Name: Misoprostol vaginal insert

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346840

Locations

United Kingdom
Birmingham Women's Hospital
Birmingham, United Kingdom, B13 9HP
Princess Royal Maternity Hospital
Glasgow, United Kingdom, G11 5DY
King George Hospital
Ilford, United Kingdom, IG3 8YB
Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS
Northampton General Hospital
Northampton, United Kingdom, NN1 5BD
The Queen's Mother's Hospital
Yorkhill, Glasgow, United Kingdom, G12 9TZ

Sponsors and Collaborators

Cytokine PharmaSciences

Investigators

Study Director:

Helen Colquhoun, MD

Pleiad, Inc.

More Information

Publications:

Ewert 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.

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.

Rayburn 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.

Responsible Party:	Barbara Powers, Vice President, Clinical Development, Cytokine PharmaSciences
ClinicalTrials.gov Identifier:	NCT00346840 History of Changes
Other Study ID Numbers:	Miso-Obs-002
Study First Received:	June 29, 2006
Last Updated:	November 12, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cytokine PharmaSciences:

Labor induction
cervical ripening
misoprostol
vaginal insert

Additional relevant MeSH terms:

Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on February 12, 2012