Clinical trial NCT00376493: Prolonged Treatment for Infected Abortion After Hospital Discharge.
Official title: Prolonged Treatment for Infected Abortion After Hospital Discharge.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Septic Abortion
Keywords: Abortion
Infection
Antibiotics
Treatment
Pregnancy complications
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2006-09-15
Enrollment: 56
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Hospital re-admission
timeFrame: 7 days after hospital discharge
Secondary outcomes:
measure: minimal or absent vaginal bleeding
timeFrame: 7 days after hospital discharge
measure: walking normally
timeFrame: 7 days after hospital discharge
measure: important decrease of pain
timeFrame: 7 days after hospital discharge
measure: no fever
timeFrame: 7 days after hospital discharge
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo F Savaris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Adriani O Galão, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
citation: Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.
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. doi: 10.1016/s0002-9378(98)70143-7.
citation: Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.
citation: 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.
citation: 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.
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. doi: 10.1136/bmj.319.7211.670.