Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185991

Enrollment

126

Registered

2005-09-16

Start date

2004-06-30

Completion date

2010-02-28

Last updated

2011-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chorioamnionitis

Brief summary

To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Interventions

DRUGgentamicin

Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- clinical diagnosis of chorioamnionitis

Exclusion criteria

\- maternal renal disease, intrauterine fetal death, allergy to gentamicin

Design outcomes

Primary

Measure	Time frame
Afebrile at 24 hours and no endometritis	24 hours after delivery

Secondary

Measure	Time frame
Neonatal outcomes	Time of delivery to time of discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026