NCT02061657

Brief Summary

The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 12, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

February 11, 2014

Last Update Submit

August 9, 2014

Conditions

Leiomyoma

Outcome Measures

Primary Outcomes (1)

  • intraoperative blood loss

    time from peritoneum opening till its closure around (1 Hour)

Study Arms (2)

Myomectomy, rectal Misoprostol

EXPERIMENTAL

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.

Drug: Misoprostol

Myomectomy, Placebo

ACTIVE COMPARATOR

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Drug: Placebo( for misoprostol)

Interventions

MisoprostolDRUG

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation

Also known as: Cytotec
Myomectomy, rectal Misoprostol
Placebo( for misoprostol)DRUG

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Myomectomy, Placebo

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal patients aged between 35 to 50 years old.
  • Five or less symptomatic uterine myomas .
  • Maximum diameter of the largest myoma is 6 cm .
  • All myomas are subserous or intramural.
  • Uterine size less than 24 weeks pregnancy

You may not qualify if:

  • History of previous surgery.
  • Allergy to Misoprostol.
  • Hypertension.
  • Cardiac and Pulmonary diseases.
  • Patients who have bleeding disorders.
  • Anemia (Hb \< 10g %).
  • Chronic endocrine or metabolic diseases such as Diabetes.
  • Obesity (body mass index \> 30 kg/m2).
  • Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

  • Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.

    PMID: 26174128DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Abd El Mgeed I. Abd El Mgeed, Professor

    Ain Shams University

    STUDY CHAIR

  • Mohamed S. Ali, Professor

    Ain Shams University

    STUDY DIRECTOR

  • Mohamed A. Abdel-Hafeez, Lecturer

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Mina A. Yacoup, Fellow

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Ahmed M. Elnaggar, Lecturer

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

August 12, 2014

Record last verified: 2014-07

Locations

EG(1)