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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842100
First Posted: April 29, 2013
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Hong Kong
  Purpose
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 Intervention
Induced Abortion Postaboral Pelvic Inflammatory Disease Sexually Transmitted Infections Drug: Universal antibiotic prophylaxis Other: Screen-and-treat

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Rate of postabortal inflammatory disease 6 weeks after induced abortion. [ Time Frame: 6 weeks after induced abortion. ]

Secondary Outcome Measures:
  • Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion. [ Time Frame: 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 ]

Enrollment: 2193
Study Start Date: September 1999
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842100


Locations
China, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Sofie SF Yung, MBBS, MRCOG The University of Hong Kong
  More Information

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01842100     History of Changes
Other Study ID Numbers: QMHRC99 - 15 RC/B/121
First Submitted: April 21, 2013
First Posted: April 29, 2013
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by The University of Hong Kong:
Induced abortion
Postaboral pelvic inflammatory disease
Sexually transmitted infections
Universal antibiotic prophylaxis
Screen-and-treat approach

Additional relevant MeSH terms:
Communicable Diseases
Sexually Transmitted Diseases
Pelvic Inflammatory Disease
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
Infection
Pelvic Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents