To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy

Study Overview
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Brief Summary
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Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by sexually transmitted infections when compared to the universal antibiotic prophylaxis strategy.

Detailed Description
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While universal antibiotic prophylaxis during induced abortion has been proven to reduce postabortal pelvic inflammatory diseases, screen-and-treat approach has the potential benefit of altering women's sexual behavior and preventing further re-infection by sexually transmitted infections. We conducted a randomized controlled trial to compare the effect of the two approaches in preventing postabortal pelvic inflammatory disease and the women's sexual behavior.

Official Title
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To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy

Conditions
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Induced Abortion, Postaboral Pelvic Inflammatory Disease, Sexually Transmitted Infections

Intervention / Treatment
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* Drug: Universal antibiotic prophylaxis
* Other: Screen-and-treat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women requesting for induced abortion in the gynecology clinic Exclusion Criteria: nil
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Universal antibiotic prophylaxis<br>In the universal prophylaxis group, all women received doxycycline 100 mg twice daily for 7 days starting on the day of induced abortion. Screening for sexually transmitted diseases was done as baseline but the results were not revealed to the patients. | Drug: Universal antibiotic prophylaxis<br>* 100 mg twice daily for 7 days starting on the day of induced abortion<br>|
| Active Comparator: Screen-and-treat<br>In the screen-and-treat group, the results of screening for sexually transmitted infections (STI) were revealed to the patients. They would only receive appropriate specific antibiotics treatment only if they were screened positive for any of the STIs. If they were found to have STI, their sexual partners would also be referred to the local social hygiene clinics for contact tracing and treatment. Contraception by barrier methods would also be advised. | Other: Screen-and-treat<br>* Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postabortal inflammatory disease 6 weeks after induced abortion. |  | 6 weeks after induced abortion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion. |  | 24 weeks after induced abortion. | 
| Proportion of women having abstinence from sexual intercourse or using condom at 6 weeks, 24 weeks and 1 year after induced abortion. |  | 6 weeks, 24 weeks and 1 year after induced abortion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced abortion, Postaboral pelvic inflammatory disease, Sexually transmitted infections, Universal antibiotic prophylaxis, Screen-and-treat approach