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

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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

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.

Condition or disease Intervention/treatment Phase
Maternal Infection During Pregnancy (Diagnosis) Neonatal Infection Drug: Cefoxitin Drug: oxytocin/misoprostol Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Immediate induction with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis
Drug: Cefoxitin
Drug: oxytocin/misoprostol
Active Comparator: Immediate induction without antibiotic prophylaxis
Immediate induction without antibiotic prophylaxis
Drug: oxytocin/misoprostol
Active Comparator: Delayed induction with antibiotic prophylaxis
Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
Drug: Cefoxitin
Drug: oxytocin/misoprostol



Primary Outcome Measures :
  1. Maternal and neonatal infection rate [ Time Frame: intrapartum and immediate postpartum ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02985086


Contacts
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Contact: Filipa FV Passos, MD 00351966634530 filipafariavazpassos@gmail.com
Contact: Rita Silva, MD 00351963915366 r.i.t.a.i.m.s.i.l.v.a@gmail.com

Locations
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Portugal
Hospital Garcia de Orta, EPE Recruiting
Almada, Portugal
Hospital de Santa Maria, CHLN, EPE Recruiting
Lisbon, Portugal
Sponsors and Collaborators
Hospital de Santa Maria, Portugal

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Responsible Party: Filipa Faria Vaz Passos, Principal Investigator, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT02985086     History of Changes
Other Study ID Numbers: SantaMariaGarciadeOrtaPortugal
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Keywords provided by Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal:
term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Anti-Bacterial Agents
Cefoxitin
Antibiotics, Antitubercular
Misoprostol
Oxytocin
Anti-Infective Agents
Antitubercular Agents
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents