Abortion, SepticAPANCT00353743
The Use of Antibiotics After Hospital Discharge in Septic Abortion
A study testing doxycycline plus metronidazole in people with Abortion, Septic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abortion, Septic
- What is being tested?
- doxycycline plus metronidazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- May 2006to Dec 2007
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients admitted at the hospital with a diagnosis of infected abortion and about to be discharged from the hospital.
- Use of intravenous antibiotics (gentamicin and clindamycin)
- Improvement of the clinical conditions for at least 48 hours (no fever, eating and walking normally, reduced vaginal bleeding)
Who cannot join
- Unwilling to participate in the study.
- Use of antibiotics previously within one week.
- Presence of tubo-ovarian abscess.
- Known allergy to doxycycline or metronidazole.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínias de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion.
The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
Read the detailed description
Septic abortion is still a major cause of maternal mortality in developing countries. According to the WHO, 1 woman dies for every 270 illegal abortion (Ahman E, 2004). Infected abortion has an important role in maternal morbidity and mortality (Stubblefield PG, 1994). the diagnosis of infected abortion must be considered when a patient presents a history of delayed menses, vaginal bleeding, abdominal pain and fever (Brasil, 2000)
Prompt diagnosis and treatment are paramount steps to prevent complications. At Hospital de Clínicas de Porto Alegre, the use of gentamycin plus clindamicin before curettage is preconized (Savaris R, 2006). Nevertheless, the time of treatment it is not well established, varying from 7-14 days (Brasil, 2000).
A recent study with post-partum endometritis has shown that it is not necessary to extend the treatment to 14 days, after clinical improvement (Turnquest MA, 1998; French LM, 2004)
A randomized clinical trial comparing placebo with the standard protocol of treatment would define weather both treatments are equivalent or not.
Comparison: The prolonged use of antibiotics, after intravenous use of antibiotics and clinical improvement, will be compared to the use of placebo in cases of septic abortion.
Sample size and ethical issues The study protocol was approved by the ethics committee of Hospital de Clínicas de Porto Alegre.
To compare equivalence between the 2 treatments we calculated the sample size considering an alpha error of 0.05, a beta error of 0.1, and difference between the two groups of no more than 10%. We expected a 99% clinical cure with the standard protocol, and 95% for the alternative one. These figures yield a minimum of 42 patients in each group. Interim analysis will performed at 58 for possible early stopping, if clinical cure was < 95%, or for sample size re-estimation.
Randomization and treatment Subjects will be allocated in blocks of four at a time to create the allocation sequence. If the patient was eligible for the study, she will be allocated to one of the 2 treatments. The allocation will be concealed, coded and obtained from a central telephone number. Patients and those who assessed the outcomes were blind to group assignment. To avoid bias, both medications were manipulated by the hospital pharmacy and put in identically coded blisters and capsules.
Statistical analysis Student´s t-test, Mann-Whitney test, and Fisher´s exact test will be used for statistical analysis. The rates of cure were analyzed by "modified" intention to treat (Keech AC, 2003) and per protocol with 95% confidence intervals.
- Conditions
- Abortion, Septic
- Being tested
- placebo, doxycycline plus metronidazole
- Keywords
- infected abortion, treatment period, doxycycline, metronidazole, placebo
- Medical subject headings
- Abortion, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo
doxycycline plus metronidazoleDrug
Also called Vibramicina, Flagyl
doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day Receives: Drug: doxycycline plus metronidazole |
| 2 | Placebo comparator | Patients that do not receive antibiotics, only placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure defined as no fever, no abdominal pain or bleeding.
Measured: 10 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionDec 2007
Why it stopped: Rate of cure was higher than expected, IRB suspended for no additional benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abortion, SepticStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo F Savaris, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353743
- Sponsor's protocol ID
- 05-452
- Other IDs
- GPPG 05-452
- Acronym
- APA
- Status last verified
- Mar 2007
- First submitted
- 13 Jul 2006
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahman E, Shah I. Unsafe abortion: worldwide estimates for 2000. Reprod Health Matters. 2002 May;10(19):13-7. doi: 10.1016/s0968-8080(02)00012-5.
PubMed 12369316Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
PubMed 8022443Brasil.Ministério da Saúde. Abortamento infectado. In: Ministério da Saúde, ed. Urgências e emergências maternas: guia para diagnóstico e conduta em situações de risco de morte materna. 1 ed. Brasília: MS/FEBRASGO; 2000: 13-17.
Savaris R. Abortamento. In: Freitas FM, Costa SMH, Lopes JG, eds. Rotinas em Obstetrícia. 5 ed. Porto Alegre: Artmed; 2006: 70-77.
Turnquest MA, How HY, Cook CR, O'Rourke TP, Cureton AC, Spinnato JA, Brown HL. Chorioamnionitis: is continuation of antibiotic therapy necessary after cesarean section? Am J Obstet Gynecol. 1998 Nov;179(5):1261-6. doi: 10.1016/s0002-9378(98)70143-7.
PubMed 9822512French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.
PubMed 15495005Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust. 2003 Oct 20;179(8):438-40. doi: 10.5694/j.1326-5377.2003.tb05627.x. No abstract available.
PubMed 14558871
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
- ClinicalTrials.gov ID
- NCT00353743
- Acronym / sponsor ID
- APA / 05-452
- Conditions
- Abortion, Septic
- Keywords
- infected abortion, treatment period, doxycycline, metronidazole, placebo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rate of cure was higher than expected, IRB suspended for no additional benefit
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Jul 2006 (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.
The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion.
The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
Detailed description
Septic abortion is still a major cause of maternal mortality in developing countries. According to the WHO, 1 woman dies for every 270 illegal abortion (Ahman E, 2004). Infected abortion has an important role in maternal morbidity and mortality (Stubblefield PG, 1994). the diagnosis of infected abortion must be considered when a patient presents a history of delayed menses, vaginal bleeding, abdominal pain and fever (Brasil, 2000)
Prompt diagnosis and treatment are paramount steps to prevent complications. At Hospital de Clínicas de Porto Alegre, the use of gentamycin plus clindamicin before curettage is preconized (Savaris R, 2006). Nevertheless, the time of treatment it is not well established, varying from 7-14 days (Brasil, 2000).
A recent study with post-partum endometritis has shown that it is not necessary to extend the treatment to 14 days, after clinical improvement (Turnquest MA, 1998; French LM, 2004)
A randomized clinical trial comparing placebo with the standard protocol of treatment would define weather both treatments are equivalent or not.
Comparison: The prolonged use of antibiotics, after intravenous use of antibiotics and clinical improvement, will be compared to the use of placebo in cases of septic abortion.
Sample size and ethical issues The study protocol was approved by the ethics committee of Hospital de Clínicas de Porto Alegre.
To compare equivalence between the 2 treatments we calculated the sample size considering an alpha error of 0.05, a beta error of 0.1, and difference between the two groups of no more than 10%. We expected a 99% clinical cure with the standard protocol, and 95% for the alternative one. These figures yield a minimum of 42 patients in each group. Interim analysis will performed at 58 for possible early stopping, if clinical cure was < 95%, or for sample size re-estimation.
Randomization and treatment Subjects will be allocated in blocks of four at a time to create the allocation sequence. If the patient was eligible for the study, she will be allocated to one of the 2 treatments. The allocation will be concealed, coded and obtained from a central telephone number. Patients and those who assessed the outcomes were blind to group assignment. To avoid bias, both medications were manipulated by the hospital pharmacy and put in identically coded blisters and capsules.
Statistical analysis Student´s t-test, Mann-Whitney test, and Fisher´s exact test will be used for statistical analysis. The rates of cure were analyzed by "modified" intention to treat (Keech AC, 2003) and per protocol with 95% confidence intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: doxycycline plus metronidazolePatients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day |
| 2 | Placebo comparator | Drug: placeboPatients that do not receive antibiotics, only placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients admitted at the hospital with a diagnosis of infected abortion and about to be discharged from the hospital.
- Use of intravenous antibiotics (gentamicin and clindamycin)
- Improvement of the clinical conditions for at least 48 hours (no fever, eating and walking normally, reduced vaginal bleeding)
Key exclusion criteria (4 listed)
- Unwilling to participate in the study.
- Use of antibiotics previously within one week.
- Presence of tubo-ovarian abscess.
- Known allergy to doxycycline or metronidazole.
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 |
|---|---|---|
| placeboplacebo | Drug | 2 |
| doxycycline plus metronidazoleAlso: Vibramicina, Flagyldoxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment) | Drug | 1 |
Primary outcome
Clinical cure defined as no fever, no abdominal pain or bleeding.
Time frame: 10 days after hospital discharge
Results and safety
The study was stopped early (reason given: Rate of cure was higher than expected, IRB suspended for no additional benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
- Background: PubMed 12369316Ahman E, Shah I. Unsafe abortion: worldwide estimates for 2000. Reprod Health Matters. 2002 May;10(19):13-7. doi: 10.1016/s0968-8080(02)00012-5.
- Background: PubMed 8022443Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
- BackgroundBrasil.Ministério da Saúde. Abortamento infectado. In: Ministério da Saúde, ed. Urgências e emergências maternas: guia para diagnóstico e conduta em situações de risco de morte materna. 1 ed. Brasília: MS/FEBRASGO; 2000: 13-17.
- BackgroundSavaris R. Abortamento. In: Freitas FM, Costa SMH, Lopes JG, eds. Rotinas em Obstetrícia. 5 ed. Porto Alegre: Artmed; 2006: 70-77.
- Background: PubMed 9822512Turnquest MA, How HY, Cook CR, O'Rourke TP, Cureton AC, Spinnato JA, Brown HL. Chorioamnionitis: is continuation of antibiotic therapy necessary after cesarean section? Am J Obstet Gynecol. 1998 Nov;179(5):1261-6. doi: 10.1016/s0002-9378(98)70143-7.
- Background: PubMed 15495005French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.
- Background: PubMed 14558871Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust. 2003 Oct 20;179(8):438-40. doi: 10.5694/j.1326-5377.2003.tb05627.x. No abstract available.
- location of the studyLink provided by the sponsor.
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.
Ricardo F Savaris, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxycycline plus metronidazole in people with Abortion, Septic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Dec 2008. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Rate of cure was higher than expected, IRB suspended for no additional benefit). Results are not available in the source record.
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?
Clinical cure defined as no fever, no abdominal pain or bleeding. (time frame: 10 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353743, which also lists 7 linked publications.
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 19 Dec 2008.