Trials / Completed
CompletedNCT04280874
Induction of Labor in Term Pregnancies With Unfavourable Cervix
Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- Clinical Hospital Merkur · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
Detailed description
This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.
Conditions
- Induction of Labor Affected Fetus / Newborn
- Prostaglandins Causing Adverse Effects in Therapeutic Use
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dinoprostone 0.5 MG | 0.5mg dinoprostone applied intracervically |
| DRUG | Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly | 2mg dinoprostone applied intravaginally |
Timeline
- Start date
- 2018-12-10
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2020-02-21
- Last updated
- 2020-07-21
Locations
1 site across 1 country: Croatia
Source: ClinicalTrials.gov record NCT04280874. Inclusion in this directory is not an endorsement.