The Use of Antibiotics After Hospital Discharge in Septic Abortion
Information source: Hospital de Clinicas de Porto Alegre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abortion, Septic
Intervention: placebo (Drug); doxycycline plus metronidazole (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Hospital de Clinicas de Porto Alegre Official(s) and/or principal investigator(s):
Ricardo F Savaris, MD, PhD, Principal Investigator, Affiliation: Hospital de Clínicas de Porto Alegre
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.
The purpose of the present study is to verify the need of antibiotics after clinical
improvement in cases of septic abortion.
Clinical Details
Official title: A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Clinical cure defined as no fever, no abdominal pain or bleeding.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Unwilling to participate in the study.
- Use of antibiotics previously within one week.
- Presence of tubo-ovarian abscess.
- Known allergy to doxycycline or metronidazole.
Locations and Contacts
Hospital de Clínias de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-003, Brazil
Additional Information
location of the study
Related publications: Ahman E, Shah I. Unsafe abortion: worldwide estimates for 2000. Reprod Health Matters. 2002 May;10(19):13-7. Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. Review. 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. French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. Review. Heritier 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. Review. No abstract available.
Starting date: May 2006
Ending date: December 2007
Last updated: May 8, 2008
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