Back to results

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

Primary Purpose

Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection

Status

Unknown status

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Cefoxitin

oxytocin/misoprostol

About this trial

This is an interventional prevention trial for Maternal Infection During Pregnancy (Diagnosis) focused on measuring term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hospital Garcia de Orta, EPERecruiting
Hospital de Santa Maria, CHLN, EPERecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Immediate induction with antibiotic prophylaxis

Immediate induction without antibiotic prophylaxis

Delayed induction with antibiotic prophylaxis

Arm Description

Immediate induction with antibiotic prophylaxis

Immediate induction without antibiotic prophylaxis

Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis

Outcomes

Primary Outcome Measures

Maternal and neonatal infection rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02985086

First Posted

December 5, 2016

Last Updated

December 10, 2016

Sponsor

Hospital de Santa Maria, Portugal

1. Study Identification

Unique Protocol Identification Number

NCT02985086

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Santa Maria, Portugal

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection

Keywords

term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

568 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate induction with antibiotic prophylaxis

Arm Type

Active Comparator

Arm Description

Immediate induction with antibiotic prophylaxis

Arm Title

Immediate induction without antibiotic prophylaxis

Arm Type

Active Comparator

Arm Description

Immediate induction without antibiotic prophylaxis

Arm Title

Delayed induction with antibiotic prophylaxis

Arm Type

Active Comparator

Arm Description

Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis

Intervention Type

Drug

Intervention Name(s)

Cefoxitin

Intervention Type

Drug

Intervention Name(s)

oxytocin/misoprostol

Primary Outcome Measure Information:

Title

Maternal and neonatal infection rate

Time Frame

intrapartum and immediate postpartum

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Filipa FV Passos, MD

Phone

00351966634530

filipafariavazpassos@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rita Silva, MD

Phone

00351963915366

r.i.t.a.i.m.s.i.l.v.a@gmail.com

Facility Information:

Facility Name

Hospital Garcia de Orta, EPE

City

Almada

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Hospital de Santa Maria, CHLN, EPE

City

Lisbon

Country

Portugal

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs