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

NCT00346840 | Completed Phase 2

• 1 other identifier: Miso-Obs-002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Labor Induction; Cervical Ripening

Keywords

Labor induction; cervical ripening; misoprostol; vaginal insert

Outcome Measures

Primary Outcomes (1)

• Time to vaginal delivery.

  From insertion of study drug to neonate delivery

Secondary Outcomes (5)

• uterine hyperstimulation

  From insertion of study drug to neonate delivery

• safety in terms of maternal, fetal and neonatal adverse events

  From insertion of study drug to neonate delivery

• Success on composite modified Bishop score (MBS)at 12 hours after drug insertion

  From insertion of study drug to 12 hours

• frequency and amount of oxytocin use

  From insertion of study drug to neonate delivery

• drug release characteristics in terms of residual concentrations

  From insertion of study drug to removal of study drug

Study Arms (4)

MVI 25

EXPERIMENTAL

Misoprostol vaginal insert 25 mcg

Drug: Misoprostol vaginal insert 25 mcg

MVI 50

EXPERIMENTAL

Misoprostol vaginal insert 50 mcg

Drug: Misoprostol vaginal insert 50 mcg

MVI 100

EXPERIMENTAL

Misoprostol vaginal insert 100 mcg

Drug: Misoprostol vaginal insert 100 mcg

MVI 200

EXPERIMENTAL

Misoprostol vaginal insert 200 mcg

Drug: Misoprostol vaginal insert 200 mcg

Interventions

Misoprostol vaginal insert 25 mcg DRUG

One hydrogel polymer vaginal insert for up to 24h

Also known as: Misoprostol vaginal insert

MVI 25

Misoprostol vaginal insert 50 mcg DRUG

One hydrogel polymer vaginal insert for up to 24h

Also known as: Misoprostol vaginal insert

MVI 50

Misoprostol vaginal insert 100 mcg DRUG

One hydrogel polymer vaginal insert for up to 24h

Also known as: Misoprostol vaginal insert

MVI 100

Misoprostol vaginal insert 200 mcg DRUG

One hydrogel polymer vaginal insert for up to 24h

Also known as: Misoprostol vaginal insert

MVI 200

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (6)

Birmingham Women's Hospital

Birmingham, B13 9HP, United Kingdom

Location

Princess Royal Maternity Hospital

Glasgow, G11 5DY, United Kingdom

Location

King George Hospital

Ilford, IG3 8YB, United Kingdom

Location

Liverpool Women's Hospital

Liverpool, L8 7SS, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

The Queen's Mother's Hospital

Yorkhill, Glasgow, G12 9TZ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 16157114 BACKGROUND

• 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. doi: 10.1016/j.jsgi.2005.10.004.

  PMID: 16443504 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000239100.16166.5a.

  PMID: 17077234 RESULT

Study Officials

• Helen Colquhoun, MD

  Pleiad, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: June 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: March 1, 2004
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

GB (6)