A Phase 2/3 interventional study of Ampicillin + gentamicin in Chorioamnionitis, Puerperal Endometritis and Neonatal Early Onset Sepsis, sponsored by Hospital de Santa Maria, Portugal. Completed at 1 site in Portugal. Open to female participants. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Hospital de Santa Maria, Portugal · Phase 2/3, Interventional, and Prevention
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's enrollment of 161 is close to the median of 157 across 22 interventional studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Hospital de Santa Maria, Portugal is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
women submitted to antibiotic prophylaxis
Drug: Ampicillin + gentamicin
Drug pages: Ampicillin · Gentamicins
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
neonatal infection rate
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
comparison of the infection rates between prompt and delayed induction
rate of maternal and neonatal infection between prompt (\<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
The record gives a start of Oct 2008, a primary completion of Jan 2011 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ampicillin · Gentamicins
Hospital de Santa Maria, Portugal