Infection, miscarriage, sepsis, antibiotic prophylaxis Pregnancy and Childbirth
Conditions
Interventions
1. Doxycycline 400 mg oral and Metronidazole 400 mg oral, taken approximately 2 hours before the scheduled time of surgery
2. Placebo tablets of identical appearance and weight
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a spontaneous miscarriage (under 22 weeks gestation) 2. Women undergoing surgical evacuation of the uterus (by manual vacuum aspiration, suction curettage or sharp curettage) 3. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Induced abortion of pregnancy 2. Septic miscarriage or evidence of infection 3. Allergy to either of the antibiotics 4. Current antibiotic use, or antibiotic use in the 7 days preceding surgical evacuation 5. Current febrile illness (temperature < 38oC) 7. Other contraindication to doxycycline or metronidazole use 8. Patient with condition requiring immediate care e.g. severe haemorrhage 9. Age less than 16 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/01/2017: Pelvic infection within 14* days of surgery, defined as two or more of: 1. Purulent vaginal discharge - on vaginal examination 2. Pyrexia >38.0°C - using a standardised tympanic thermometer 3. Tenderness on clinical examination 4. A white cell count >12x109/l , with no other recognised cause of infection 5. Or one of the above features, with the clinically identified need (following clinical assessment) to administer antibiotics for the treatment of presumed pelvic infection. *In cases where participants do not return for follow up within this period, follow up until 28 days will be acceptable Previous primary outcome measures: Pelvic infection within 14 days of surgery, defined as two or more of: 1. Purulent vaginal discharge 2. Pyrexia >38.0°C 3. Uterine tenderness on examination and d) a white cell count >15x10^9 /l, with no other recognised cause of infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/01/2017: 1. Secondary outcome measures: Assessed at the follow-up appointment with a clinical assessment, history taking and reviewing available patient medical records: 1.1. Overall antibiotic use 1.2. Each component of the primary outcome 1.3. Death 1.4. Hospital admission 1.5. Unplanned consultations 1.6. Blood transfusion 1.7. Vomiting 1.8. Diarrhoea 1.9. Adverse events 1.10. Anaphylaxis and allergy 1.11. Duration of clinical symptoms (pain, additional analgesia, vaginal bleeding) 1.12. Days before return to usual daily activities 2. Outcomes for exploratory analyses: 2.1. Surgical complications 2.2. Full microbiological information, antibiotic sensitivities and any evidence of drug resistance will be collected where available 3. Resource use outcomes: Resource use data will be prospectively collected to estimate the costs associated with the additional use of antibiotics in all participating centres in both arms of the trial. The main resources to be monitored include: 3.1. Additional staff time for explanation and dispensing of the medication 3.2. Type and grade of the health professional caring for each woman 3.3. Inpatient admissions and consultations (planned and unplanned) 3.4. Outpatient and emergency admissions and consultations 3.5. Unplanned further surgical interventions (e.g. curettage) 3.6. Additional investigation costs (e.g. ultrasounds) 3.7. Consumables (e.g. medication) 3.8. Resources used to manage surgery and treatment related complications (e.g. bleeding requiring transfusion | — |
Countries
Malawi, Pakistan, Tanzania, Uganda
Outcome results
None listed