Prolonged Treatment for Infected Abortion After Hospital Discharge.

Septic Abortion Clinical Trial

— APA  

Official title:

Prolonged Treatment for Infected Abortion After Hospital Discharge.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00376493
• Other study ID #: APA 05-452
• Status: Terminated
• Phase: Phase 4
• First received: September 14, 2006
• Last updated: March 10, 2008
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Septic
• Septic Abortion

Intervention

Drug:
• metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

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. — View Citation

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

Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital re-admission		7 days after hospital discharge	Yes
Secondary	minimal or absent vaginal bleeding		7 days after hospital discharge	Yes
Secondary	walking normally		7 days after hospital discharge	Yes
Secondary	important decrease of pain		7 days after hospital discharge	Yes
Secondary	no fever		7 days after hospital discharge	Yes