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Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

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.
 
ClinicalTrials.gov Identifier: NCT02985086
Recruitment Status : Unknown
Verified December 2016 by Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal.
Recruitment status was:  Recruiting
First Posted : December 7, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
Maternal and neonatal infection rate [ Time Frame: intrapartum and immediate postpartum ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02985086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis
Official Title  ICMJE The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
Brief Summary The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.
Detailed Description In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Infection During Pregnancy (Diagnosis)
  • Neonatal Infection
Intervention  ICMJE
  • Drug: Cefoxitin
  • Drug: oxytocin/misoprostol
Study Arms  ICMJE
  • Active Comparator: Immediate induction with antibiotic prophylaxis
    Immediate induction with antibiotic prophylaxis
    Interventions:
    • Drug: Cefoxitin
    • Drug: oxytocin/misoprostol
  • Active Comparator: Immediate induction without antibiotic prophylaxis
    Immediate induction without antibiotic prophylaxis
    Intervention: Drug: oxytocin/misoprostol
  • Active Comparator: Delayed induction with antibiotic prophylaxis
    Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
    Interventions:
    • Drug: Cefoxitin
    • Drug: oxytocin/misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
568
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a 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, contraindication to expectant management or to vaginal delivery
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02985086
Other Study ID Numbers  ICMJE SantaMariaGarciadeOrtaPortugal
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal
Study Sponsor  ICMJE Hospital de Santa Maria, Portugal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital de Santa Maria, Portugal
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP