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A RANDOMISED OPEN COMPARISON OF INTRAVAGINAL APL202 (25µg) FOLLOWED BY 25µg AFTER 4 AND 8 HOURS VERSUS 3mg of DINOPROSTONE AS A VAGINAL TABLET FOLLOWED BY 3mg AFTER 6 HOURS IN THE INDUCTION OF LABOUR IN MULTIPAROUS SUBJECTS.

A RANDOMISED OPEN COMPARISON OF INTRAVAGINAL APL202 (25µg) FOLLOWED BY 25µg AFTER 4 AND 8 HOURS VERSUS 3mg of DINOPROSTONE AS A VAGINAL TABLET FOLLOWED BY 3mg AFTER 6 HOURS IN THE INDUCTION OF LABOUR IN MULTIPAROUS SUBJECTS.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000108-42-GB
Enrollment
415
Registered
2005-05-03
Start date
2004-11-04
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy: induction of labour

Interventions

Product Code: APL202 Pharmaceutical Form: Vaginal tablet INN or Proposed INN: misoprostol CAS Number: 59122-46-2 Current Sponsor code: APL202 Concentration unit: µg microgram(s) Concentration type: eq

Sponsors

Alliance Pharmaceuticals
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects, aged 18 years or over, having at least one previous term pregnancy suitable for induction of labour with prostaglandin cervical ripening agents. 2. Pregnancy duration of at least 37 weeks. 3. Subjects with an unfavourable cervix defined as a Bishop’s Score of less than 9 (see Appendix II) 4. 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: 1. Subjects who are diabetic. 2. Subjects with a multiple pregnancy. 3. Subjects in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate.

Design outcomes

Primary

MeasureTime frame
Main Objective: 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): 1. Number of vaginal deliveries within 24 hours of the start of induction.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026