The Use of Antibiotics After Hospital Discharge in Septic Abortion (APA)

• ClinicalTrials.gov Identifier: NCT00353743
• Recruitment Status: Terminated
• First Posted: July 19, 2006
• Last Update Posted: December 19, 2008
• Sponsor: Hospital de Clinicas de Porto Alegre
• Information provided by: Hospital de Clinicas de Porto Alegre

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Abortion, Septic	Drug: placebo; Drug: doxycycline plus metronidazole	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
• Study Start Date: May 2006
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Patients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day	Drug: doxycycline plus metronidazole; doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment); Other Names: Vibramicina; Flagyl
Placebo Comparator: 2; Patients that do not receive antibiotics, only placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures :

1. Clinical cure defined as no fever, no abdominal pain or bleeding. [ Time Frame: 10 days after hospital discharge ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Hospital de Clínias de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035-003

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Ricardo F Savaris, MD, PhD; Hospital de Clínicas de Porto Alegre

More Information

Additional Information:

location of the study 

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.

Brasil.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.

French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. Review. Update in: Cochrane Database Syst Rev. 2015;2:CD001067.

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.

• Responsible Party: Ricardo Francalacci Savaris, HCPA-UFRGS
• ClinicalTrials.gov Identifier: NCT00353743
• Other Study ID Numbers: 05-452; GPPG 05-452
• First Posted: July 19, 2006
• Last Update Posted: December 19, 2008
• Last Verified: March 2007

Keywords provided by Hospital de Clinicas de Porto Alegre:

infected abortion; treatment period; doxycycline; metronidazole; placebo

Additional relevant MeSH terms:

Abortion, Septic; Pregnancy Complications, Infectious; Infection; Abortion, Spontaneous; Pregnancy Complications; Anti-Bacterial Agents; Metronidazole; Doxycycline; Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials