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

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.

Study Overview

• Status: Terminated
• Conditions: Septic Abortion
• Intervention / Treatment: Drug: metronidazole and doxycycline

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital re-admission	7 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
minimal or absent vaginal bleeding	7 days after hospital discharge
walking normally	7 days after hospital discharge
important decrease of pain	7 days after hospital discharge
no fever	7 days after hospital discharge

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Ricardo F Savaris, MD, PhD, Hospital de Clinicas de Porto Alegre; Principal Investigator: Adriani O Galão, MD, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• 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. doi: 10.1136/bmj.319.7211.670.
• 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. doi: 10.7326/0003-4819-134-8-200104170-00012.
• Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
• Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. 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. doi: 10.1016/s0002-9378(98)70143-7.
• Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.
• French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 14, 2006
• First Submitted That Met QC Criteria: September 14, 2006
• First Posted (Estimate): September 15, 2006

Study Record Updates

• Last Update Posted (Estimate): March 13, 2008
• Last Update Submitted That Met QC Criteria: March 10, 2008
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Treatment; Infection; Antibiotics; Pregnancy complications; Abortion
• Additional Relevant MeSH Terms: Infections; Pregnancy Complications; Abortion, Spontaneous; Pregnancy Complications, Infectious; Abortion, Septic; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Metronidazole; Doxycycline
• Other Study ID Numbers: APA 05-452