Laminaria and Misoprostol Before Operative Hysteroscopy | NCT03388827

Studies
Laminaria and Misoprostol Before Operative Hysteroscopy

NCT03388827

Sponsor

Zagazig University

Status

Unknown status

Last Update Posted

Dec 7, 2018Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Cervical Spasm

Interventions

Laminaria tent
Laminaria plus Misoprostol

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2017Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Dec 25, 2017

First Submission Date that Met QC Criteria

Dec 25, 2017

First Posted Date

Jan 3, 2018Actual

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

Dec 6, 2018

Last Update Posted Date

Dec 7, 2018Actual

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

Laminaria and Misoprostol before Operative Hysteroscopy

Detailed Description

The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laminaria	Experimental	Laminaria tent was introduced in the cervical canal	Device: Laminaria tent
Laminaria plus Misoprostol	Active Comparator	Laminaria and Misoprostol were introduced	Drug: Laminaria plus Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laminaria tent	Device	Laminaria tent was inserted for 12 hours before Hysteroscopy	Laminaria

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preoperative cervical width	cervical width in Hegar dilators number	12 hours

Secondary Outcomes

Measure	Description	Time Frame
adverse effects	adverse effects of the method used or hysteroscopy	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: nullipara

need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

contraindication to misoprostol

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

Name	Role	Phone	Extension	Email
ibrahim A EL sharkwy	Contact	00966554818576		ibrahimsharkwy@yahoo.com
mohamed L elsayed	Contact	00201222442467		drmohamedlotfy@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University	Recruiting	Zagazig			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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