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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT01842100

Collaborator

(none)

2,193

Enrollment

Location

Arms

Duration (Months)

28.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Induced Abortion Postaboral Pelvic Inflammatory Disease Sexually Transmitted Infections	Drug: Universal antibiotic prophylaxis Other: Screen-and-treat	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2193 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Universal antibiotic prophylaxis

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

100 mg twice daily for 7 days starting on the day of induced abortion

Active Comparator: Screen-and-treat

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

Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.

Outcome Measures

Primary Outcome Measures

Rate of postabortal inflammatory disease 6 weeks after induced abortion. [6 weeks after induced abortion.]

Secondary Outcome Measures

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]