Immediate Versus Delayed Induction in Term-PROM Using or... | NCT02985086

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

NCT02985086

Sponsor

Hospital de Santa Maria, Portugal

Status

Unknown status

Last Update Posted

Dec 13, 2016Estimated

Enrollment

568Estimated

Phase

Not Applicable

Conditions

Maternal Infection During Pregnancy (Diagnosis)
Neonatal Infection

Interventions

Cefoxitin
oxytocin/misoprostol

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Dec 5, 2016

First Submission Date that Met QC Criteria

Dec 5, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2016

Last Update Posted Date

Dec 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Filipa Faria Vaz Passos, Principal Investigator, Hospital de Santa Maria, PortugalPrincipal Investigator

Lead Sponsor

Hospital de Santa Maria, PortugalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

568Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cefoxitin	Drug		Delayed induction with antibiotic prophylaxis Immediate induction with antibiotic prophylaxis
oxytocin/misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal and neonatal infection rate		intrapartum and immediate postpartum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Filipa FV Passos, MD	Contact	00351966634530		filipafariavazpassos@gmail.com
Rita Silva, MD	Contact	00351963915366		r.i.t.a.i.m.s.i.l.v.a@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Garcia de Orta, EPE	Recruiting	Almada			Portugal
Hospital de Santa Maria, CHLN, EPE

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D005322	Fetal Membranes, Premature Rupture
D002821	Chorioamnionitis
D004716	Endometritis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002440	Cefoxitin
D010121	Oxytocin
D016595	Misoprostol

Ancestor Terms

ID	Term
D002513	Cephamycins
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided