Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography

NCT04500509 — Not applicable, Completed, 200 participants, Aswan University Hospital

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

Registry	NCT04500509
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	200 (Actual)
Sponsor	Aswan University Hospital (Other)
Conditions	Infertility, Female
Interventions	diclofenac potassium + dinoprostone, diclofenac potassium + placebo (Drug)
Dates	start 2020-09-01, primary completion 2021-08-01, completion 2021-10-30, first posted 2020-08-05, last updated 2022-01-19
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group A	Experimental	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
Group B	Placebo comparator	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

diclofenac potassium + dinoprostone (Drug): 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
diclofenac potassium + placebo (Drug): 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 outcomes

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 outcomes

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

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* primary infertility female came for HSG

Exclusion Criteria:

* any patient has contraindication to HSG

+Locations (1)

Facility	City	Country	Status
Aswan University Hospital	Aswān	Egypt

+Investigators

nahla w Shady, md, Study chair, Aswan universirty

My Notes

Public

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