Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- No of participants in each arm that develop Fever
Study Overview
Brief Summary
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.
Detailed Description
Hysterosalpingography is a radiological procedure that outlines the female genital tract1. It is routinely done as part of work up for female infertility with the aim of identifying lesions that may cause female factor infertility1. It is considered as a minor gynaecological procedure2.
The procedure involves exposing the cervix with a bivalve speculum and injecting a contrast medium through a cannula that is applied to the cervix. Images of the genital tract are then obtained by fluoroscopy.
The lower genital tract is rich in micro flora. The natural milieu of the lower genital tract prevents infection. However, the upper genital tract is sterile. Microorganisms can ascend from the lower genital tract to the upper genital tract through the cervix and lead to infections. Infections of the upper genital tract can result in acute or chronic pelvic infection with subsequent chronic abdominal pain, ectopic pregnancy, menstrual irregularities and infertility as a result of inflammation and scarring of the fallopian tubes.
Hysterosalpingography can lead to transcervical transmission of microorganisms from the lower genital tract to the upper genital tract. Cervical trauma during the procedure can facilitate ascending infection. Also, direct transcervical transfer of microorganisms from the lower genital tract to the upper genital tract can occur.
Different approaches of preventing iatrogenic upper genital tract infection following hysterosalpingography exist. Prophylactic antibiotics can be given to all clients undergoing the procedure. On the other hand, prophylactic antibiotics may be limited to only those that have symptoms suggestive of genital tract infection based on their history. However, this may not suffice because some genital tract infections are mainly asymptomatic. Another approach is to screen all clients undergoing hysterosalpingography for genital tract infection and treat as necessary. Screening may also be limited to those with history suggestive of genital tract infection. This approach may also miss the clients with asymptomatic infections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
The drugs given to participants in Groups A and B are in capsules and have thesame size and packaging but different colors. They will be put in a brown envelop to cover the color. The brown envelops will then be labelled with study number based in the numbers generated by the Random number table (WINPEPI) by a research assistant to ensure the principal investigators do not know the drug inside the brown envelopes. The participants will take the drugs at home. This ensures that the care provider, investigators and outcomes assessors do not know the drug the patient takes. However the patient will know the drug she takes since the drug is labelled.
The
Eligibility Criteria
- Ages
- 15 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
study
Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 3/7.
Intervention: Doxycycline Capsule (Drug)
control
Group B will be the study group and will be given oral Multivitamin capsule i bd for 3/7
Intervention: Multivitamins W/Iron Tab (Drug)
Outcomes
Primary Outcomes
No of participants in each arm that develop Fever
Time Frame: 24 hours to 10 days after the procedure
Axillary temperature of ≥38.0oC
No of participants in each arm that develop Clinical features of pelvic infection
Time Frame: within 2 weeks of the procedure
Lower abdominal pain, abnormal vaginal discharge, radiological/laboratory evidence of pelvic infection ( Significant fluid collection in the pouch of Douglas)
No of participants in each arm that develop the Need for antibiotics treatment.
Time Frame: within 2 weeks of procedure
Requirement for antibiotic therapy for pelvic infection
Secondary Outcomes
- No of participants in each arm that develop Side effects to the antibiotics(within 24 hours after the procedure.)
Investigators
Anisah Yahya
Dr
Ahmadu Bello University Teaching Hospital