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

April 24, 2013 updated by: The University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

  • nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of postabortal inflammatory disease 6 weeks after induced abortion.
Time Frame: 6 weeks after induced abortion.
6 weeks after induced abortion.

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion.
Time Frame: 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.
Time Frame: 6 weeks, 24 weeks and 1 year after induced abortion
6 weeks, 24 weeks and 1 year after induced abortion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Sofie SF Yung, MBBS, MRCOG, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

April 21, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QMHRC99 - 15 RC/B/121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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