Induction of Labor in Term Pregnancies With Unfavourable... | NCT04280874

Studies
Induction of Labor in Term Pregnancies With Unfavourable Cervix

NCT04280874

Sponsor

Clinical Hospital Merkur

Status

Completed

Last Update Posted

Jul 21, 2020Actual

Enrollment

212Actual

Phase

Phase 4

Conditions

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

Interventions

Dinoprostone 0.5 MG
Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2018Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Feb 14, 2020

First Submission Date that Met QC Criteria

Feb 20, 2020

First Posted Date

Feb 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2020

Last Update Posted Date

Jul 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP A	Active Comparator	106 randomly selected pregnant women	Drug: Dinoprostone 0.5 MG
GROUP B	Active Comparator	106 randomly selected pregnant women	Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dinoprostone 0.5 MG	Drug	0.5mg dinoprostone applied intracervically	GROUP A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time period between beginning of labor induction to delivery	hours (difference of 4 hours or more is considered significant)	5 days

Secondary Outcomes

Measure	Description	Time Frame
number of births within 24h of start of labor induction	N (%)	7 days
number of deliveries by caesarean section or instrumental deliveries	N (%)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katja Vince, MD	Clinical Hospital Merkur	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Hospital Merkur		Zagreb		1000	Croatia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 28, 2021
Reset	Aug 20, 2021

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 28, 2021			Aug 20, 2021

Intervention Browse Module

MeSH Terms

ID	Term
D015232	Dinoprostone
C501608	KLK15 protein, human

Ancestor Terms

ID	Term
D011458	Prostaglandins E
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided