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Comparison of different pain relief methods in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised controlled trial - Trial PACTR202203895560162

Access comprehensive clinical trial information for PACTR202203895560162 through Pure Global AI's free database. This Not Applicable trial is sponsored by Dr. Peter Chibuzor Oriji and is currently Recruiting. The study focuses on Obstetrics and Gynecology.

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PACTR202203895560162
Not Applicable
Recruiting
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202203895560162
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Comparison of different pain relief methods in infertile women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomised controlled trial

Study Focus

Obstetrics and Gynecology

Sponsor & Location

Dr. Peter Chibuzor Oriji

Nigeria

Timeline & Enrollment

Not Applicable

Apr 01, 2020

Jan 01, 1900

Summary

Infertility is defined as the failure of a couple to conceive โ‰ฅ12 months of regular unprotected intercourse. It affects 6.6% and 26.4% of reproductive-aged women. Tubal abnormalities account for 30โ€“40% of cases of infertility. Hysterosalpingography is considered the initial diagnostic tool for assessment of tubal patency. Additionally, it can be useful in the diagnosis of intrauterine pathology.This randomised controlled trial is being conducted at the radiology departments and infertility clinics of the Federal Medical Centre, Yenagoa and Niger Delta University Teaching Hospital, Okolobiri, both in Bayelsa State, Nigeria. Three hundred and eighty infertile women undergoing hysterosalpingography will be enrolled in the study. Women in Group I will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 3 ml of water for injection. Women in Group II will receive intramuscular diclofenac 75 mg (3 ml) and paracervical block with 2% lignocaine. Women in Group III will receive intramuscular diclofenac 75 mg (3 ml) and intrauterine instillation of 2% lignocaine. Women in Group IV will receive intramuscular diclofenac 75 mg (3 ml) and 5% lignocaine cream applied on the cervix.Infertile women referred for hysterosalpingography, and women that gave consent and completely filled the consent/questionnaire form will be included in the study.Exclusion criteria included abnormal uterine/vaginal bleeding before the procedure, on-going menstruation, pregnancy, discharge on inspection of the cervix, cervical stenosis/cervical pathology, evidence of pelvic inflammatory disease, previous history of contrast hypersensitivity, history of allergy to diclofenac and lignocaine, and all patients that declined consent.

ICD-10 Classifications

Obstetric and gynaecological devices associated with adverse incidents
Obstructed labour due to other maternal pelvic abnormalities
Obstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classified
Obstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devices
Other complications of obstetric surgery and procedures

Data Source

Pan Africa Clinical Trials Registry

PACTR202203895560162

Non-Device Trial