We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633294
First Posted: July 4, 2012
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal
  Purpose
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.

Condition Intervention Phase
Chorioamnionitis Puerperal Endometritis Neonatal Early Onset Sepsis Neonatal Meningitis Neonatal Pneumonia Drug: Ampicillin + gentamicin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal:

Primary Outcome Measures:
  • neonatal infection rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    neonatal infection rate includes early onset sepsis, meningitis and pneumonia

  • maternal infection rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    maternal infection rate includes chorioamnionitis or puerperal endometritis


Secondary Outcome Measures:
  • comparison of the infection rates between prompt and delayed induction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
    rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis


Enrollment: 161
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotic group
women submitted to antibiotic prophylaxis
Drug: Ampicillin + gentamicin
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
No Intervention: Control group

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • term (≥ 37+0 weeks) singleton pregnancy
  • a vertex presentation
  • ruptured membranes for less than 12 hours
  • negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks

Exclusion Criteria:

  • active labor
  • absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
  • contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633294


Locations
Portugal
Hospital Santa Maria
Lisboa, Portugal, 1649-035
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Investigators
Principal Investigator: Filipa Faria Vaz Passos, Dr Santa Maria Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filipa Faria Vaz Passos, Principal investigator, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT01633294     History of Changes
Other Study ID Numbers: 335/08 - 28/07/08
First Submitted: June 23, 2012
First Posted: July 4, 2012
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal:
premature rupture of membranes
term pregnancy
chorioamnionitis
endometritis
neonatal sepsis
antibiotic prophylaxis

Additional relevant MeSH terms:
Pneumonia
Sepsis
Meningitis
Rupture
Endometritis
Chorioamnionitis
Fetal Membranes, Premature Rupture
Neonatal Sepsis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Fetal Diseases
Pregnancy Complications
Obstetric Labor Complications
Placenta Diseases
Infant, Newborn, Diseases
Anti-Bacterial Agents
Gentamicins
Ampicillin