Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

Sponsor

Aswan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04500509

Collaborator

(none)

200

Enrollment

Location

Arms

13.9

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our study is to determine the efficacy of oral diclofenac potassium with or without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients on the pain scores during HSG.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: diclofenac potassium + dinoprostone Drug: diclofenac potassium + placebo	N/A

Detailed Description

hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind placebo controlled trialdouble blind placebo controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double blind placebo controlled trial

Primary Purpose:

Prevention

Official Title:

Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure	Drug: diclofenac potassium + dinoprostone patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient
Placebo Comparator: Group B patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure	Drug: diclofenac potassium + placebo patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient

Arm

Intervention/Treatment

Experimental: Group A

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure

Drug: diclofenac potassium + dinoprostone

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient

Placebo Comparator: Group B

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure

Drug: diclofenac potassium + placebo

patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient

Outcome Measures

Primary Outcome Measures

Mean pain score during hysterosalpigography by visual analog scale [15 minutes]
pain during hysterosalpigography assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary Outcome Measures

Intensity of pain [30 minutes after the procedure]
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

primary infertility female came for HSG

Exclusion Criteria:

any patient has contraindication to HSG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

Study Chair: nahla w Shady, md, Aswan universirty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, A Professor, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT04500509

Other Study ID Numbers:

aswu/352/3/19

First Posted:

Aug 5, 2020

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022