Vaginally Administered Versus Per Oral Misoprostol in Ind... | NCT02539199

Studies
Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

NCT02539199

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

270Actual

Phase

Phase 4

Conditions

Labour Induction

Interventions

Misoprostol, modified-release pessary
Misoprostol, per-oral tablets

Countries

Finland

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-001972-23	EudraCT Number

Status Module

Record Verification Date

Apr 2018

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

Sep 2015

Primary Completion Date

Mar 2, 2018Actual

Completion Date

Mar 2, 2018Actual

First Submitted Date

Aug 31, 2015

First Submission Date that Met QC Criteria

Sep 1, 2015

First Posted Date

Sep 2, 2015Estimated

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

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Name	Class
Helsinki University Central Hospital	OTHER
Oulu University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.

Detailed Description

Not provided

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

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol modified-release pessary	Active Comparator		Drug: Misoprostol, modified-release pessary
Misoprostol, per-oral tablets	Active Comparator		Drug: Misoprostol, per-oral tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol, modified-release pessary	Drug	Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours	Misoprostol modified-release pessary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cesarean section rate		at time of child birth

Secondary Outcomes

Measure	Description	Time Frame
The time from beginning of induction to child birth		up to child birth
Neonatal Apgar score		1, 5, 10 minutes after child birth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nulliparous
Singleton at term pregnancy (>36+6 weeks)
Unfavourable cervix (Bishop score < 6)
Fetal cephalic position

Exclusion Criteria:

Pre-term pregnancy (<37 weeks)
Multiple pregnancy
Rupture of membranes
Other than fetal cephalic position
Intra-uterine growth retardation
Severe pre-eclampsia
Severe hypertension
Previous cesarean section

Accepts Healthy Volunteers

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
Kati Tihtonen, PhD, MD	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University hospital		Helsinki			Finland
Kuopio University Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided