Vaginal Misoprostol and Foley Catheter for Late Second Tr... | NCT02989324

Studies
Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

NCT02989324

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Feb 7, 2018Actual

Enrollment

97Actual

Phase

Phase 2

Conditions

Late Second Trimester Termination of Pregnancy

Interventions

MisoprostoL
Foley Catheter

Countries

Egypt

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

Status Module

Record Verification Date

Nov 2016

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

Jan 2016Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Nov 30, 2016

First Submission Date that Met QC Criteria

Dec 7, 2016

First Posted Date

Dec 12, 2016Estimated

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

Feb 6, 2018

Last Update Posted Date

Feb 7, 2018Actual

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

Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Detailed Description

this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal Misoprosto	Experimental	Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section	Drug: MisoprostoL
Misoprostol Plus Foley Catheter	Active Comparator	Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections	Drug: MisoprostoL Device: Foley Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MisoprostoL	Drug	Vaginal MisoprostoL	Misoprostol Plus Foley Catheter Vaginal Misoprosto

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
induction to expulsion interval	from time to start induction to time of complete expulsion of product of conception	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:late second trimester

IUFD
Previous Multiple Cesarean Sections

Exclusion Criteria:Low lying placenta

asthma
allergy to misoprostol
patient refuse to participate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ibrahim A el sharkwy, MD	FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University		Zagazig			Egypt

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

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