Status:
COMPLETED
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Labor Induction
Cervical Ripening
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ho...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00346840
Start Date
June 1 2003
End Date
March 1 2004
Last Update
June 18 2012
Active Locations (6)
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1
Birmingham Women's Hospital
Birmingham, United Kingdom, B13 9HP
2
Princess Royal Maternity Hospital
Glasgow, United Kingdom, G11 5DY
3
King George Hospital
Ilford, United Kingdom, IG3 8YB
4
Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS