Pregnancy: induction of labour
Conditions
Interventions
Product Code: APL202
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: misoprostol
CAS Number: 59122-46-2
Current Sponsor code: A
Sponsors
Alliance Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Nulliparous subjects, aged 18 years or over, with a singleton pregnancy suitable for induction of labour with prostaglandin cervical ripening agents. -Pregnancy duration of at least 37 weeks. -Subjects with an un-favourable cervix defined as a Bishop’s Score of less the 9. -Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects who are diabetic. -Subjects with a multi-fetal pregnancy. -Subjects in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and efficacy of 2 dosage regimens of APL-202 in the induction of labour compared to the standard agent currently used for cervical ripening.;Secondary Objective: N/A;Primary end point(s): -Number of vaginal deliveries within 24 hours of the start of induction. | — |
Countries
United Kingdom
Outcome results
None listed