Induced AbortionNCT01842100
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
A study testing Universal antibiotic prophylaxis and Screen-and-treat in people with Induced Abortion and Postaboral Pelvic Inflammatory Disease, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induced Abortion, Postaboral Pelvic Inflammatory Disease, Sexually Transmitted Infections
- What is being tested?
- Universal antibiotic prophylaxis and Screen-and-treat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,193 participants
- Where
- 1 siteChina
- Study dates
- Sep 1999to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women requesting for induced abortion in the gynecology clinic
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Universal antibiotic prophylaxis, Screen-and-treat
- Keywords
- Induced abortion, Postaboral pelvic inflammatory disease, Sexually transmitted infections, Universal antibiotic prophylaxis, Screen-and-treat approach
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal antibiotic prophylaxisDrug
100 mg twice daily for 7 days starting on the day of induced abortion
Screen-and-treatOther
Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Screen-and-treat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postabortal inflammatory disease 6 weeks after induced abortion.
Measured: 6 weeks after induced abortion.
Secondary outcomes (2)
Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion.
Measured: 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.
Measured: 6 weeks, 24 weeks and 1 year after induced abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startSep 1999
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofie SF Yung, MBBS, MRCOG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842100
- Sponsor's protocol ID
- QMHRC99 - 15 RC/B/121
- Status last verified
- Apr 2013
- First submitted
- 21 Apr 2013
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01842100
- Acronym / sponsor ID
- QMHRC99 - 15 RC/B/121
- Keywords
- Induced abortion, Postaboral pelvic inflammatory disease, Sexually transmitted infections, Universal antibiotic prophylaxis, Screen-and-treat approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,193 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal antibiotic prophylaxis | Active comparator | Drug: Universal antibiotic prophylaxisIn 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. |
| Screen-and-treat | Active comparator | Other: Screen-and-treatIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women requesting for induced abortion in the gynecology clinic
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal antibiotic prophylaxis100 mg twice daily for 7 days starting on the day of induced abortion | Drug | Universal antibiotic prophylaxis |
| Screen-and-treatSpecific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening. | Other | Screen-and-treat |
Primary outcome
Rate of postabortal inflammatory disease 6 weeks after induced abortion.
Time frame: 6 weeks after induced abortion.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofie SF Yung, MBBS, MRCOG principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal antibiotic prophylaxis and Screen-and-treat in people with Induced Abortion and Postaboral Pelvic Inflammatory Disease, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postabortal inflammatory disease 6 weeks after induced abortion. (time frame: 6 weeks after induced abortion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.