Single-dose Vaginal Dinoprostone and Hysterectomy

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04080323
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy	Drug: Dinoprostone 3 mg; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
• Actual Study Start Date: Sep 25, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dinoprostone 3 mg 60 minutes before the surgery 3 mg of dinoprostone inserted vaginally	Drug: Dinoprostone 3 mg; 1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
Placebo Comparator: placebo 60 minutes before the surgery 1 tablet of placebo inserted vaginally	Drug: placebo; 1 vaginal tablet of placebo 60 minutes before surgery

Outcome Measures

Primary Outcome Measures

1. decrease blood loss during hysterectomy [intraoperative]

   decrease blood loss during hysterectomy in ml

Secondary Outcome Measures

1. postoperative hemoglobin level [24 hours]

   postoperative hemoglobin level in gm/dl

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Samy	Giza		Egypt	11231

Sponsors and Collaborators

• Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Samy aly ashour, assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04080323
• Other Study ID Numbers: dinoprostone hysterectomy
• First Posted: Sep 6, 2019
• Last Update Posted: Aug 27, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dinoprostone

Study Results

No Results Posted as of Aug 27, 2020