Single-dose Vaginal Dinoprostone and Hysterectomy | NCT04080323

Studies
Single-dose Vaginal Dinoprostone and Hysterectomy

NCT04080323

Sponsor

Cairo University

Status

Completed

Last Update Posted

Aug 27, 2020Actual

Enrollment

118Actual

Phase

Phase 3

Conditions

Hysterectomy

Interventions

Dinoprostone 3 mg
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

Aug 2020

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

Sep 25, 2019Actual

Primary Completion Date

May 30, 2020Actual

Completion Date

Jun 30, 2020Actual

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

Aug 25, 2020

Last Update Posted Date

Aug 27, 2020Actual

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

In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

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

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dinoprostone 3 mg	Experimental	60 minutes before the surgery 3 mg of dinoprostone inserted vaginally	Drug: Dinoprostone 3 mg
placebo	Placebo Comparator	60 minutes before the surgery 1 tablet of placebo inserted vaginally	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dinoprostone 3 mg	Drug	1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery	dinoprostone 3 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease blood loss during hysterectomy	decrease blood loss during hysterectomy in ml	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
postoperative hemoglobin level	postoperative hemoglobin level in gm/dl	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients presenting for hysterectomy for any benign indication including uterine fibroids.
- Age ≥ 18 years
- Pre-operative hemoglobin >8 g/dl
- Willing to have dinoprostone or a placebo prior to hysterectomy
- Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Patients with known or suspected endometrial/ovarian/cervical cancer.
- Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
- Patients currently undergoing treatment for any type of cancer.
- Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
- History of allergic reactions to dinoprostone.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AHMED SAMY	Cairo University	Study Director
ayman taher, MD	Cairo University	Principal Investigator
ahmed S Ali	faculty of medicine al-azhar university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Samy		Giza		11231	Egypt

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

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Browse Branches

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