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NCT01842100 Clinical Trial

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

Sexually Transmitted Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01842100
Other study ID # QMHRC99 - 15 RC/B/121
Secondary ID
Status Completed
Phase N/A
First received April 21, 2013
Last updated April 24, 2013
Start date September 1999
Est. completion date February 2006

Study information
Verified date April 2013
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 2193
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Universal antibiotic prophylaxis
100 mg twice daily for 7 days starting on the day of induced abortion
Other:
• Screen-and-treat
Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.

Locations
Country Name City State
China Queen Mary Hospital Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of postabortal inflammatory disease 6 weeks after induced abortion. 6 weeks after induced abortion. No
Secondary Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion. 24 weeks after induced abortion. No
Secondary 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 No
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