Vaginal Misoprostol Versus Bilateral Uterine Artery Ligat... | NCT02643186

Studies
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

NCT02643186

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2015Estimated

Enrollment

62Estimated

Phase

Phase 4

Conditions

Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Interventions

preoperative vaginal misoprostol
bilateral uterine artery ligation

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

Status Module

Record Verification Date

Dec 2015

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 2015

Primary Completion Date

Jul 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 21, 2015

First Submission Date that Met QC Criteria

Dec 29, 2015

First Posted Date

Dec 31, 2015Estimated

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 29, 2015

Last Update Posted Date

Dec 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
misoprostol group	Active Comparator	preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy	Drug: preoperative vaginal misoprostol
uterine artery ligation group	Active Comparator	bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy	Procedure: bilateral uterine artery ligation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preoperative vaginal misoprostol	Drug	preoperative vaginal misoprostol 400 micrograms 1 hour before surgery	misoprostol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
estimated intraoperative blood loss measured in milliliters		60 min

Secondary Outcomes

Measure	Description	Time Frame
the need of intra-operative blood transfusion	Below a hemoglobin concentration of 7 g/dL requiring blood transfusion. It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10).	60 min
the need for conversion from myomectomy to hysterectomy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
pain (dull aching lower abdominal pain or dysmenorrhea)
pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
maximum diameter of the largest fibroid is greater than 4 cm
maximum number of uterine myomas is not to be more than 5 myomas
uterine fibroid may be subserous or intramural

Exclusion Criteria:

obesity (BMI >30 kg/m2)
cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
patients known to be allergic to prostaglandin preparations
patients who received preoperative hormonal therapy (GnRH analogue)
patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
patients with positive pregnancy test
virgin patients

Accepts Healthy Volunteers

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

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors