Prolonged Treatment for Infected Abortion After Hospital Discharge. - Full Text View

Sponsor:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00376493

Purpose

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.

Condition	Intervention	Phase
Septic Abortion	Drug: metronidazole and doxycycline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prolonged Treatment for Infected Abortion After Hospital Discharge.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Doxycycline Doxycycline hyclate Metronidazole hydrochloride Metronidazole phosphate Doxycycline calcium Metronidazole

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Hospital re-admission [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

minimal or absent vaginal bleeding [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
walking normally [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
important decrease of pain [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
no fever [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment:	56
Study Start Date:	May 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Use of antibiotics after hospital discharge	Drug: metronidazole and doxycycline use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
Placebo Comparator: 2 Use of placebo	Drug: metronidazole and doxycycline use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

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.

Eligibility

Ages Eligible for Study:	14 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)
Cyanosis and/or paleness
tachypnea(> 30mpm)
Arterial hypotension (SAP< 90mmHg)
Oliguria
Fever (> or = than 37,8°C)

Exclusion Criteria:

Refusal to participate in the project
Prior use of antibiotics within one week
Known allergy to Doxycycline or Metronidazole
Presence of tubo-ovarian abscess

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376493

Locations

Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, 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
Principal Investigator:	Adriani O Galão, MD, PhD	Hospital de Clínicas de Porto Alegre

More Information

Publications:

Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. Review.

Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. Review. No abstract available.

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.

Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. Review.

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

Altman 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. Review.

Hollis 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. Review.

Responsible Party:	Ricardo Francalacci Savaris, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00376493 History of Changes
Other Study ID Numbers:	APA 05-452
Study First Received:	September 14, 2006
Last Updated:	March 10, 2008
Health Authority:	Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:

Abortion
Infection
Antibiotics
Treatment
Pregnancy complications

Additional relevant MeSH terms:

Abortion, Septic
Pregnancy Complications, Infectious
Infection
Abortion, Spontaneous
Pregnancy Complications
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Metronidazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012