Preoperative Vaginal Dinoprostone Prior to Abdominal Myom... | NCT04080375

Studies
Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

NCT04080375

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 6, 2019Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Myomectomy

Interventions

Dinoprostone 3 mg
placebo

Countries

Not provided

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2019Estimated

Primary Completion Date

Nov 30, 2019Estimated

Completion Date

Dec 10, 2019Estimated

First Submitted Date

Sep 4, 2019

First Submission Date that Met QC Criteria

Sep 4, 2019

First Posted Date

Sep 6, 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

Sep 4, 2019

Last Update Posted Date

Sep 6, 2019Actual

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

The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dinoprostone 3 mg	Experimental	patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery	Drug: Dinoprostone 3 mg
placebo	Placebo Comparator	patients will take 1 tablet of placebo 1 hour before the surgery	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dinoprostone 3 mg	Drug	the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery	dinoprostone 3 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean amount of intraoperative blood loss	Mean amount of intraoperative blood loss in ml	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Change of hemoglobin after surgery	Change of hemoglobin(g/dl) after surgery	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin >8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
- Five or less symptomatic uterine myomas
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

• Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
- Cardiac and Pulmonary diseases.
- Obesity (body mass index > 30 kg/m2).
- History of allergic reactions attributed to misoprostol
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AHMED SAMY	Contact	+201100681167		ahmedsamy8233@gmail.com

Overall Officials

Name	Affiliation	Role
AHMED SAMY	Cairo University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015232	Dinoprostone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided