Trial record 3 of 76 for:    pelvic inflammatory disease AND (woman OR women OR female)

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:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01842100
First received: April 21, 2013
Last updated: April 24, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion. [ Time Frame: 24 weeks after induced abortion. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

  • nil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01842100     History of Changes
Other Study ID Numbers: QMHRC99 - 15 RC/B/121
Study First Received: April 21, 2013
Last Updated: April 24, 2013
Health Authority: Hong Kong: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

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:
Sexually Transmitted Diseases
Pelvic Inflammatory Disease
Pelvic Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 20, 2014