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Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00346840
First received: June 29, 2006
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  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 2

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 Ferring Pharmaceuticals:

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
Ferring Pharmaceuticals
Investigators
Study Director: Helen Colquhoun, MD Pleiad, Inc.
  More Information

Publications:

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00346840     History of Changes
Other Study ID Numbers: Miso-Obs-002
Study First Received: June 29, 2006
Last Updated: June 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ferring Pharmaceuticals:
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 June 18, 2013