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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

NCT ID: NCT01633294

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Meningitis Neonatal Pneumonia Chorioamnionitis Puerperal Endometritis Neonatal Early Onset Sepsis

Keywords

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premature rupture of membranes term pregnancy chorioamnionitis endometritis neonatal sepsis antibiotic prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antibiotic group

women submitted to antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Ampicillin + gentamicin

Intervention Type DRUG

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ampicillin + gentamicin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Santa Maria, Portugal

OTHER

Sponsor Role lead

Responsible Party

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Filipa Faria Vaz Passos

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filipa Faria Vaz Passos, Dr

Role: PRINCIPAL_INVESTIGATOR

Santa Maria Hospital

Locations

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Hospital Santa Maria

Lisbon, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 23090521 (View on PubMed)

Other Identifiers

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335/08 - 28/07/08

Identifier Type: -

Identifier Source: org_study_id