Role of Vaginal Misoprostol Prior to IUCD Insertion in Wo... | NCT03939663

Studies
Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

NCT03939663

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

May 7, 2019Actual

Enrollment

210Estimated

Phase

Phase 2

Conditions

IUD Insertion Complication

Interventions

misoprostol
Placebo

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

Jun 2018

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

Jul 1, 2018Actual

Primary Completion Date

Jul 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

May 4, 2019

First Submission Date that Met QC Criteria

May 4, 2019

First Posted Date

May 7, 2019Actual

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

May 4, 2019

Last Update Posted Date

May 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Enas Mahmoud Mohammed Mohammed Elshahed, MBBCh., Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.

Detailed Description

Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.

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

210Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo group	Placebo Comparator	2 tablets vaginally	Drug: Placebo
misoprostol group	Experimental	400 mcg vaginally	Drug: misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
misoprostol	Drug	misoprostol 2 tablets	misoprostol group	misotac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the proportion of failed IUCD insertions regardless of the reason .	pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale	during insertion
the degree of difficulty of the IUCD insertion .	Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale.	during insertion

Secondary Outcomes

Measure	Description	Time Frame
heavy bleeding	heavy bleeding and blood clots	7 days
partial or total expulsion	not insitu by U/S	4 to 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women will be 20 to 40 years of age.
Desires IUCD placement and able to participate.
Negative pregnancy test.
Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit.
Delivered only by cesarean section.

Exclusion Criteria:

Active cervical infection.
Current pregnancy.
Uterine anomaly.
Fibroid uterus.
Copper allergy/Wilson's disease.
Undiagnosed abnormal uterine bleeding.
Cervical or uterine cancer.
Allergy to misoprostol.
Previous vaginal delivery.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
enas mahmoud, MBBCh	Contact	01096448037	01122742293	enasmahmoud957@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Enas Mahmoud	Recruiting	Cairo		9999	Egypt

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