NCT00376493

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 13, 2008

Status Verified

December 1, 2007

Enrollment Period

1.6 years

First QC Date

September 14, 2006

Last Update Submit

March 10, 2008

Conditions

Septic Abortion

Keywords

AbortionInfectionAntibioticsTreatmentPregnancy complications

Outcome Measures

Primary Outcomes (1)

  • Hospital re-admission

    7 days after hospital discharge

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Use of antibiotics after hospital discharge

Drug: metronidazole and doxycycline

2

PLACEBO COMPARATOR

Use of placebo

Drug: metronidazole and doxycycline

Interventions

metronidazole and doxycyclineDRUG

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

12

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (7)

  • Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.

    PMID: 8022443BACKGROUND

  • Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.

    PMID: 12048413BACKGROUND

  • 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.

    PMID: 9822512BACKGROUND

  • Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.

    PMID: 16085035BACKGROUND

  • 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.

    PMID: 15495005BACKGROUND

  • 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.

    PMID: 11304107BACKGROUND

  • 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.

    PMID: 10480822BACKGROUND

MeSH Terms

Conditions

Abortion, SepticInfectionsPregnancy Complications

Interventions

MetronidazoleDoxycycline

Condition Hierarchy (Ancestors)

Pregnancy Complications, InfectiousAbortion, SpontaneousFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ricardo F Savaris, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Adriani O Galão, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 13, 2008

Record last verified: 2007-12

Locations

BR(1)