Prolonged Treatment for Infected Abortion After Hospital Discharge. (APA)

• ClinicalTrials.gov Identifier: NCT00376493
• Recruitment Status: Terminated
• First Posted: September 15, 2006
• Last Update Posted: March 13, 2008
• Sponsor: Hospital de Clinicas de Porto Alegre
• Information provided by: Hospital de Clinicas de Porto Alegre

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Septic Abortion	Drug: metronidazole and doxycycline	Phase 4

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

• 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: Prolonged Treatment for Infected Abortion After Hospital Discharge.
• Study Start Date: May 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Hospital re-admission [ Time Frame: 7 days after hospital discharge ]

Secondary Outcome Measures :

1. minimal or absent vaginal bleeding [ Time Frame: 7 days after hospital discharge ]
2. walking normally [ Time Frame: 7 days after hospital discharge ]
3. important decrease of pain [ Time Frame: 7 days after hospital discharge ]
4. no fever [ Time Frame: 7 days after hospital discharge ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 50 Years (Child, Adult)
• Sexes 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

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.

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. Update in: Cochrane Database Syst Rev. 2015;2:CD001067.

Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche 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
• Other Study ID Numbers: APA 05-452
• First Posted: September 15, 2006
• Last Update Posted: March 13, 2008
• Last Verified: December 2007

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; Metronidazole; Doxycycline; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials