Vaginal Misoprostol Before Intrauterine Contraceptive Dev... | NCT03790371

Studies
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

NCT03790371

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Dec 31, 2018Actual

Enrollment

90Actual

Phase

Phase 3

Conditions

Contraception

Interventions

Misoprostol
Placebos

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 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

Oct 1, 2015Actual

Primary Completion Date

Aug 1, 2016Actual

Completion Date

Aug 1, 2016Actual

First Submitted Date

Dec 27, 2018

First Submission Date that Met QC Criteria

Dec 27, 2018

First Posted Date

Dec 31, 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 27, 2018

Last Update Posted Date

Dec 31, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
misoprostol group	Active Comparator	misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion	Drug: Misoprostol
placebo	Placebo Comparator	while the control group received a placebo tablet in the same regimen as the study group.	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	vaginal misoprostol prior IUD insertion	misoprostol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the success rate for IUD insertion.	the success of IUD insertion after previous attempt failure	four hours after misoprostol dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

One previous failed attempt of IUD insertion.

Exclusion Criteria:

Uterine fibroid distorting the cavity.
Anatomical uterine abnormality with distortion of the cavity
Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
Current purulent cervicitis (chlamydia or gonorrhea).
Immediately after septic abortion.
Uterus size less than 6 cm and more than 9 cm.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShams university maternity hospital		Cairo	Abbassya	11566	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

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Browse Branches

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