Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity

NCT04234945 | Unknown

• 1 other identifier: ABUTH Zaria
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Pelvic Inflammatory Disease

Outcome Measures

Primary Outcomes (3)

• No of participants in each arm that develop Fever

  Axillary temperature of ≥38.0oC

  24 hours to 10 days after the procedure

• 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

• 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 Outcomes (1)

• No of participants in each arm that develop Side effects to the antibiotics

  within 24 hours after the procedure.

Study Arms (2)

study

EXPERIMENTAL

Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 3/7.

Drug: Doxycycline Capsule

control

PLACEBO COMPARATOR

Group B will be the study group and will be given oral Multivitamin capsule i bd for 3/7

Drug: Multivitamins W/Iron Tab

Interventions

Doxycycline Capsule DRUG

Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding.

Also known as: Doxycap. Registration No: MAL 19921000A

study

Multivitamins W/Iron Tab DRUG

Group B will be the study group and will be given oral Multivitamin capsule i bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding

Also known as: Haemaron

control

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: self representation
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women who present for hysterosalpingography as routine work up for infertility.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmadu Bello University Teaching Hospital: lead

Study Sites (1)

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, PMB 06, Nigeria

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Pelvic Inflammatory Disease

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Pelvic Infection; Infections; Adnexal Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Anisah Yahya, MBBS

  Ahmadu Bello University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anisah Yahya, MBBS

CONTACT

08035925175; anisahy@yahoo.com

Hajara Umaru-Sule, MBBS

CONTACT

08034530902; hajaraumarusule@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding. Group B will be the study group and will be given oral Multivitamin capsule i bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: January 13, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)