Septic AbortionPhase 4APANCT00376493
Prolonged Treatment for Infected Abortion After Hospital Discharge.
A Phase 4 study testing metronidazole and doxycycline in people with Septic Abortion, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Septic Abortion
- What is being tested?
- metronidazole and doxycycline
- 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
- Phase 4
- 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of intrauterine manipulation with contaminated objects.
- Vaginal secretion with fetid odor
- Presence of pus flowing through the cervical uterine
- Presence of peritonitis
- Leucocytosis (> 14,000 leucocytes/mL)
- Vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (Heart rate> 110 bpm)
Show all 11Show fewer
- Cyanosis and/or paleness
- tachypnea(> 30mpm)
- Arterial hypotension (SAP< 90mmHg)
- Oliguria
- Fever (> or = than 37,8°C)
Who cannot join
- Refusal to participate in the project
- Prior use of antibiotics within one week
- Known allergy to Doxycycline or Metronidazole
- Presence of tubo-ovarian abscess
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.
Read the detailed description
The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions.
After in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment.
Cure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics.
- Conditions
- Septic Abortion
- Being tested
- metronidazole and doxycycline
- Keywords
- Abortion, Infection, Antibiotics, Treatment, Pregnancy complications
- Medical subject headings
- Abortion, Septic, Infections, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole and doxycyclineDrug
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Use of antibiotics after hospital discharge Receives: Drug: metronidazole and doxycycline |
| 2 | Placebo comparator | Use of placebo Receives: Drug: metronidazole and doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital re-admission
Measured: 7 days after hospital discharge
Secondary outcomes (4)
minimal or absent vaginal bleeding
Measured: 7 days after hospital discharge
walking normally
Measured: 7 days after hospital discharge
important decrease of pain
Measured: 7 days after hospital discharge
no fever
Measured: 7 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 posted15 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: The rate of cure in both arms was higher than expected
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 Septic AbortionStudies 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 4
- 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 AlegreAdriani O Galão, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376493
- Sponsor's protocol ID
- APA 05-452
- Acronym
- APA
- Status last verified
- Dec 2007
- First submitted
- 14 Sep 2006
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
PubMed 8022443Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.
PubMed 12048413Turnquest 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 9822512Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.
PubMed 16085035French 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 15495005Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
PubMed 11304107Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.
PubMed 10480822
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Treatment for Infected Abortion After Hospital Discharge.
- ClinicalTrials.gov ID
- NCT00376493
- Acronym / sponsor ID
- APA / APA 05-452
- Conditions
- Septic Abortion
- Keywords
- Abortion, Infection, Antibiotics, Treatment, Pregnancy complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The rate of cure in both arms was higher than expected
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Sep 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.
Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.
Detailed description
The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions.
After in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment.
Cure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics.
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: metronidazole and doxycyclineUse of antibiotics after hospital discharge |
| 2 | Placebo comparator | Drug: metronidazole and doxycyclineUse of placebo |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- History of intrauterine manipulation with contaminated objects.
- Vaginal secretion with fetid odor
- Presence of pus flowing through the cervical uterine
- Presence of peritonitis
- Leucocytosis (> 14,000 leucocytes/mL)
Key exclusion criteria (4 listed)
- Refusal to participate in the project
- Prior use of antibiotics within one week
- Known allergy to Doxycycline or Metronidazole
- Presence of tubo-ovarian abscess
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 |
|---|---|---|
| metronidazole and doxycyclineuse of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days | Drug | 1, 2 |
Primary outcome
Hospital re-admission
Time frame: 7 days after hospital discharge
4 secondary outcomes
minimal or absent vaginal bleeding
Time frame: 7 days after hospital discharge
walking normally
Time frame: 7 days after hospital discharge
important decrease of pain
Time frame: 7 days after hospital discharge
no fever
Time frame: 7 days after hospital discharge
Results and safety
The study was stopped early (reason given: The rate of cure in both arms was higher than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Background: PubMed 8022443Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
- Background: PubMed 12048413Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.
- 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 16085035Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.
- 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 11304107Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
- Background: PubMed 10480822Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.
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
Adriani O Galão, 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 Phase 4 study testing metronidazole and doxycycline in people with Septic Abortion, 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 11 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 13 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The rate of cure in both arms was higher than expected). 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?
Hospital re-admission (time frame: 7 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 NCT00376493, 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 13 Mar 2008.