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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial

NCT01633294•Hospital de Santa Maria, Portugal

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.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

Hospital Santa Maria

Lisbon, Portugal

Key Dates

Start Date

October 1, 2008

Primary Completion Date

January 1, 2011

Completion Date

January 1, 2012

Last Updated

November 28, 2016

Enrollment

161

ACTUAL participants

Conditions

ChorioamnionitisPuerperal EndometritisNeonatal Early Onset SepsisNeonatal MeningitisNeonatal Pneumonia

Interventions

Ampicillin + gentamicin

DRUG

Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo

NCT06849037

Meconium-stained Amniotic FluidChorioamnionitis

View study

RECRUITINGNA

Management of Prelabor Rupture of the Membranes at Term

NCT04307069

Fetal InfectionChorioamnionitis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Inclusion Criteria

Exclusion Criteria

Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo

Management of Prelabor Rupture of the Membranes at Term

Assessment of Labour Progress by Intrapartum Ultrasound

Infant Immune Response to Bacterial Infection

Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis