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

NCT01842100 | Completed DMC

• 1 other identifier: QMHRC99 - 15 RC/B/121
• Study Type: interventional
• Target: 2,193
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of postabortal inflammatory disease 6 weeks after induced abortion.

  6 weeks after induced abortion.

Secondary Outcomes (2)

• 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

Study Arms (2)

Universal antibiotic prophylaxis

ACTIVE COMPARATOR

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

Screen-and-treat

ACTIVE COMPARATOR

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

Interventions

Universal antibiotic prophylaxis DRUG

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

Universal antibiotic prophylaxis

Screen-and-treat OTHER

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

Screen-and-treat

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women requesting for induced abortion in the gynecology clinic

You may not qualify if:

• nil

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sofie SF Yung, MBBS, MRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2013
• First Posted: April 29, 2013
• Study Start: September 1, 1999
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

CN (1)