NCT01633294

Brief Summary

The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

June 23, 2012

Last Update Submit

November 24, 2016

Conditions

ChorioamnionitisPuerperal EndometritisNeonatal Early Onset SepsisNeonatal MeningitisNeonatal Pneumonia

Keywords

premature rupture of membranesterm pregnancychorioamnionitisendometritisneonatal sepsisantibiotic prophylaxis

Outcome Measures

Primary Outcomes (2)

  • neonatal infection rate

    neonatal infection rate includes early onset sepsis, meningitis and pneumonia

    participants will be followed for the duration of hospital stay, an expected average of 3 days

  • maternal infection rate

    maternal infection rate includes chorioamnionitis or puerperal endometritis

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes (1)

  • comparison of the infection rates between prompt and delayed induction

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (2)

Antibiotic group

ACTIVE COMPARATOR

women submitted to antibiotic prophylaxis

Drug: Ampicillin + gentamicin

Control group

NO INTERVENTION

Interventions

Ampicillin + gentamicinDRUG

ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously

Antibiotic group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
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
  • 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 (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
  • contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Related Publications (1)

  • Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.

    PMID: 23090521DERIVED

MeSH Terms

Conditions

ChorioamnionitisNeonatal SepsisFetal Membranes, Premature RuptureEndometritis

Interventions

AmpicillinGentamicins

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSepsisInfectionsInfant, Newborn, DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Penicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Filipa Faria Vaz Passos, Dr

    Santa Maria Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

June 23, 2012

First Posted

July 4, 2012

Study Start

October 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

PT(1)