Back to resultsTo 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
Primary Purpose
Induced Abortion, Postaboral Pelvic Inflammatory Disease, Sexually Transmitted Infections
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Universal antibiotic prophylaxis
Screen-and-treat
Sponsored by
About this trial
This is an interventional prevention trial for Induced Abortion focused on measuring Induced abortion, Postaboral pelvic inflammatory disease, Sexually transmitted infections, Universal antibiotic prophylaxis, Screen-and-treat approach
Eligibility Criteria
Inclusion Criteria:
- women requesting for induced abortion in the gynecology clinic
Exclusion Criteria:
- nil
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Universal antibiotic prophylaxis
Screen-and-treat
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rate of postabortal inflammatory disease 6 weeks after induced abortion.
Secondary Outcome Measures
Rate of re-infection by sexually transmitted infections 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.
Full Information
NCT ID
NCT01842100
First Posted
April 21, 2013
Last Updated
April 24, 2013
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01842100
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induced Abortion, Postaboral Pelvic Inflammatory Disease, Sexually Transmitted Infections
Keywords
Induced abortion, Postaboral pelvic inflammatory disease, Sexually transmitted infections, Universal antibiotic prophylaxis, Screen-and-treat approach
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Universal antibiotic prophylaxis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Screen-and-treat
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Universal antibiotic prophylaxis
Intervention Description
100 mg twice daily for 7 days starting on the day of induced abortion
Intervention Type
Other
Intervention Name(s)
Screen-and-treat
Intervention Description
Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.
Primary Outcome Measure Information:
Title
Rate of postabortal inflammatory disease 6 weeks after induced abortion.
Time Frame
6 weeks after induced abortion.
Secondary Outcome Measure Information:
Title
Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion.
Time Frame
24 weeks after induced abortion.
Title
Proportion of women having abstinence from sexual intercourse or using condom at 6 weeks, 24 weeks and 1 year after induced abortion.
Time Frame
6 weeks, 24 weeks and 1 year after induced abortion
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women requesting for induced abortion in the gynecology clinic
Exclusion Criteria:
nil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie SF Yung, MBBS, MRCOG
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this 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
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