Induction of Labor in Term Pregnancies With Unfavourable Cervix

NCT ID: NCT04280874

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor Affected Fetus / Newborn Prostaglandins Causing Adverse Effects in Therapeutic Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
two dinoprostone agents are randomly applied and compared - one in patient's cervix and the other in vagina without the patient knowing which agent is applied

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GROUP A

106 randomly selected pregnant women

Group Type ACTIVE_COMPARATOR

Dinoprostone 0.5 MG

Intervention Type DRUG

0.5mg dinoprostone applied intracervically

GROUP B

106 randomly selected pregnant women

Group Type ACTIVE_COMPARATOR

Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Intervention Type DRUG

2mg dinoprostone applied intravaginally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dinoprostone 0.5 MG

0.5mg dinoprostone applied intracervically

Intervention Type DRUG

Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

2mg dinoprostone applied intravaginally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PREPIDIL PROSTIN

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* term pregnancies (\> 37 weeks gestation)
* unfavourable cervix (Bishop score \<6)
* indication for labor induction
* absence of uterine contractions
* reassuring cardiotocography

Exclusion Criteria

* ruptured membranes
* scar uterus (previous caesarean section or uterus surgery)
* pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinical Hospital Merkur

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Katja Vince

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katja Vince, MD

Role: STUDY_CHAIR

Clinical Hospital Merkur

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Hospital Merkur

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RANDOM1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Balloon Project for Birth Induction
NCT01255839 COMPLETED PHASE4
Prostin and Propess in Induction of Labor
NCT01635439 COMPLETED PHASE3
PREGNANT Short Cervix Trial
NCT00615550 COMPLETED PHASE3