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NCT02985086 Clinical Trial

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

Neonatal Infection Clinical Trial

Official title:
The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02985086
Other study ID # SantaMariaGarciadeOrtaPortugal
Secondary ID
Status Recruiting
Phase N/A
First received December 5, 2016
Last updated December 10, 2016
Start date July 2013
Est. completion date July 2018

Study information
Verified date December 2016
Source Hospital de Santa Maria, Portugal
Contact Filipa FV Passos, MD
Phone 00351966634530
Email filipafariavazpassos@gmail.com
Is FDA regulated No
Health authority Portugal: Ethics Committee for Clinical Research
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 568
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cefoxitin

• oxytocin/misoprostol

Locations
Country Name City State
Portugal Hospital Garcia de Orta, EPE Almada
Portugal Hospital de Santa Maria, CHLN, EPE Lisbon

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Santa Maria, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal and neonatal infection rate intrapartum and immediate postpartum Yes
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