Infertility, Female Clinical Trial
Official title:
Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity
The study will be a parallel randomised trial. There are two groups. The first group will be given prophylactic antibiotics before a procedure (hysterosalpingography) and the second group will be given a placebo(multivitamin). Outcomes will then be assessed.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility | Inclusion Criteria: - Women who present for hysterosalpingography as routine work up for infertility. Exclusion Criteria: - Women who present for hysterosalpingography for other indications apart from infertility. - Women with history of use of antibiotics within two weeks of the procedure. - Women with symptoms of acute pelvic infection |
Country | Name | City | State |
---|---|---|---|
Nigeria | Ahmadu Bello University Teaching Hospital Shika-Zaria | Zaria | Kaduna |
Lead Sponsor | Collaborator |
---|---|
Ahmadu Bello University Teaching Hospital |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | No of participants in each arm that develop Fever | Axillary temperature of =38.0oC | 24 hours to 10 days after the procedure | |
Primary | No of participants in each arm that develop Clinical features of pelvic infection | Lower abdominal pain, abnormal vaginal discharge, radiological/laboratory evidence of pelvic infection ( Significant fluid collection in the pouch of Douglas) | within 2 weeks of the procedure | |
Primary | No of participants in each arm that develop the Need for antibiotics treatment. | Requirement for antibiotic therapy for pelvic infection | within 2 weeks of procedure | |
Secondary | No of participants in each arm that develop Side effects to the antibiotics | Nausea, vomiting, Diarrhea, skin reaction | within 24 hours after the procedure. |
Status | Clinical Trial | Phase | |
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