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

NCT ID: NCT01842100

Last Updated: 2013-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2193 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Induced Abortion Postaboral Pelvic Inflammatory Disease Sexually Transmitted Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Universal antibiotic prophylaxis

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Screen-and-treat

Intervention Type OTHER

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

Interventions

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Universal antibiotic prophylaxis

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

Intervention Type DRUG

Screen-and-treat

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women requesting for induced abortion in the gynecology clinic

Exclusion Criteria

* nil
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofie SF Yung, MBBS, MRCOG

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Other Identifiers

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QMHRC99 - 15 RC/B/121

Identifier Type: -

Identifier Source: org_study_id

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