NCT02985086

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

5 years

First QC Date

December 5, 2016

Last Update Submit

December 10, 2016

Conditions

Maternal Infection During Pregnancy (Diagnosis)Neonatal Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Maternal and neonatal infection rate

    intrapartum and immediate postpartum

Study Arms (3)

Immediate induction with antibiotic prophylaxis

ACTIVE COMPARATOR

Immediate induction with antibiotic prophylaxis

Drug: CefoxitinDrug: 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: CefoxitinDrug: oxytocin/misoprostol

Interventions

CefoxitinDRUG
Delayed induction with antibiotic prophylaxisImmediate induction with antibiotic prophylaxis
oxytocin/misoprostolDRUG
Delayed induction with antibiotic prophylaxisImmediate induction with antibiotic prophylaxisImmediate induction without antibiotic prophylaxis

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Garcia de Orta, EPE

Almada, Portugal

RECRUITING

Hospital de Santa Maria, CHLN, EPE

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

DiseaseFetal Membranes, Premature RuptureChorioamnionitisEndometritis

Interventions

CefoxitinOxytocinMisoprostol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Filipa FV Passos, MD

CONTACT

00351966634530filipafariavazpassos@gmail.com

Rita Silva, MD

CONTACT

00351963915366r.i.t.a.i.m.s.i.l.v.a@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 7, 2016

Study Start

July 1, 2013

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

PT(2)