Preoperative Vaginal Dinoprostone Versus Misoprostone in... | NCT05761418

Studies
Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

NCT05761418

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Mar 9, 2023Actual

Enrollment

90Actual

Phase

Phase 3

Conditions

Myoma;Uterus

Interventions

Dinoprostone
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

Mar 2023

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

Mar 1, 2018Actual

Primary Completion Date

Feb 15, 2023Actual

Completion Date

Feb 20, 2023Actual

First Submitted Date

Feb 23, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 9, 2023Actual

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

Mar 7, 2023

Last Update Posted Date

Mar 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

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

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

Detailed Description

Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

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
Dinoprostone	Experimental	Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.	Drug: Dinoprostone
Misoprostol	Experimental	will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.	Drug: Misoprostol
control	No Intervention	received a placebo vaginally 2 hrs. preoperatively.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dinoprostone	Drug	prostaglandin (PG) E2 analog	Dinoprostone	Dinoglandin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood loss	quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.	all time of the myomectomy operation

Secondary Outcomes

Measure	Description	Time Frame
change hemoglobin levels	Pre and Postoperative hemoglobin levels	within 1 week before operation and 24 hours after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 30-50 years
all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.

Exclusion Criteria:

contraindications to dinoprostone or misoprostol,
active PID,
history of pelvic/ ovarian endometriosis,
females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beni-Suef University	Faculty of Medicine Beni-Suef University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-suef university		Banī Suwayf			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

Condition Browse Module

MeSH Terms

ID	Term
D047708	Myofibroma

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015232	Dinoprostone
D016595	Misoprostol

Ancestor Terms

ID	Term
D011458	Prostaglandins E
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided