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Delivery induction in patients with unfavoreable obstetric conditions.

Randomized prospectic clinical trial for delivery induction in patients with unfavoreable obstetric conditions.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-000563-28-IT
Enrollment
158
Registered
2011-11-22
Start date
2012-06-25
Completion date
Unknown
Last updated
2012-07-31

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

Conditions

Delivery induction in patients with unfavoreable obstetrical conditions. MedDRA version: 14.0 Level: PT Classification code 10052856 Term: Labour induction System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Pharmaceutical Form: Vaginal delivery system INN or Proposed INN: Dinoprostone Concentration unit: mg milligram(s) Concentration number: 10- Trade Name: SINTOCIN Pharmaceutical Form: Solution for inj

Sponsors

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Single pregnancy; Gestational age > or = 37 weeks; Bishop score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous CT; Fetal weight > 4500g; Not cefalic fetal presentation; Placenta previa; Hypersensitivity to prostaglandins.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of two different schemes for delivery induction in patients who do not respond to 1 administration of intravaginal dinoprostone.;Secondary Objective: not present.;Primary end point(s): vaginal delivery.;Timepoint(s) of evaluation of this end point: At delivery.

Secondary

MeasureTime frame
Secondary end point(s): Not available.;Timepoint(s) of evaluation of this end point: ND

Countries

Italy

Contacts

Public ContactClinica Ostetrico-Ginecologica

Az. Ospedaliera Luigi Sacco

irene.cetin@unimi.it0239042264

Outcome results

None listed

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