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Trials ; 19(1): 245, 2018 Apr 23.
Article in English | MEDLINE | ID: mdl-29685179


BACKGROUND: The estimated annual global burden of miscarriage is 33 million out of 210 million pregnancies. Many women undergoing miscarriage have surgery to remove pregnancy tissues, resulting in miscarriage surgery being one of the most common operations performed in hospitals in low-income countries. Infection is a serious consequence and can result in serious illness and death. In low-income settings, the infection rate following miscarriage surgery has been reported to be high. Good quality evidence on the use of prophylactic antibiotics for surgical miscarriage management is not available. Given that miscarriage surgery is common, and infective complications are frequent and serious, prophylactic antibiotics may offer a simple and affordable intervention to improve outcomes. METHODS: Eligible patients will be approached once the diagnosis of miscarriage has been made according to local practice. Once informed consent has been given, participants will be randomly allocated using a secure internet facility (1:1 ratio) to a single dose of oral doxycycline (400 mg) and metronidazole (400 mg) or placebo. Allocation will be concealed to both the patient and the healthcare providers. A total of 3400 women will be randomised, 1700 in each arm. The medication will be given approximately 2 hours before surgery, which will be provided according to local practice. The primary outcome is pelvic infection 2 weeks after surgery. Women will be invited to the hospital for a clinical assessment at 2 weeks. Secondary outcomes include overall antibiotic use, individual components of the primary outcome, death, hospital admission, unplanned consultations, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms, and days before return to usual activities. An economic evaluation will be performed to determine if prophylactic antibiotics are cost-effective. DISCUSSION: This trial will assess whether a single dose of doxycycline (400 mg) and metronidazole (400 mg) taken orally 2 hours before miscarriage surgery can reduce the incidence of pelvic infection in women up to 2 weeks after miscarriage surgery. TRIAL REGISTRATION: Registered with the ISRCTN (international standard randomised controlled trial number) registry: ISRCTN 97143849 . (Registered on April 17, 2013).

Abortion, Spontaneous/surgery , Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis/methods , Doxycycline/administration & dosage , Gynecologic Surgical Procedures/adverse effects , Metronidazole/administration & dosage , Pelvic Infection/prevention & control , Administration, Oral , Adolescent , Adult , Anti-Bacterial Agents/adverse effects , Antibiotic Prophylaxis/adverse effects , Double-Blind Method , Doxycycline/adverse effects , Drug Administration Schedule , Female , Humans , Malawi , Metronidazole/adverse effects , Pakistan , Pelvic Infection/diagnosis , Pelvic Infection/microbiology , Pregnancy , Randomized Controlled Trials as Topic , Risk Factors , Tanzania , Time Factors , Treatment Outcome , Uganda , Young Adult
Sex Transm Dis ; 40(2): 97-102, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23324973


We critically reviewed randomized controlled trials evaluating chlamydia screening to prevent pelvic inflammatory disease (PID) and explored factors affecting interpretation and translation of trial data into public health prevention. Taken together, data from these trials offer evidence that chlamydia screening and treatment is an important and useful intervention to reduce the risk of PID among young women. However, the magnitude of benefit to be expected from screening may have been overestimated based on the earliest trials. It is likely that chlamydia screening programs have contributed to declines in PID incidence through shortening prevalent infections, although the magnitude of their contribution remains unclear. Program factors such as screening coverage as well as natural history factors such as risk of PID after repeat chlamydia infection can be important in determining the impact of chlamydia screening on PID incidence in a population. Uptake of chlamydia screening is currently suboptimal, and expansion of screening among young, sexually active women remains a priority. To reduce transmission and repeat infections, implementation of efficient strategies to treat partners of infected women is also essential. Results of ongoing randomized evaluations of the effect of screening on community-wide chlamydia prevalence and PID will also be valuable.

Chlamydia Infections/drug therapy , Chlamydia Infections/prevention & control , Chlamydia trachomatis , Mass Screening , Pelvic Infection/drug therapy , Pelvic Inflammatory Disease/prevention & control , Sexual Partners , Adolescent , Adult , Chlamydia Infections/complications , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Chlamydia trachomatis/isolation & purification , Female , Humans , Incidence , Male , Mass Screening/economics , Mass Screening/methods , Pelvic Infection/diagnosis , Pelvic Infection/epidemiology , Pelvic Infection/microbiology , Pelvic Inflammatory Disease/microbiology , Predictive Value of Tests , Prevalence , Randomized Controlled Trials as Topic , Retreatment , Secondary Prevention , Time Factors , United States/epidemiology