Trials / Completed
CompletedNCT01633294
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Hospital de Santa Maria, Portugal · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Chorioamnionitis
- Puerperal Endometritis
- Neonatal Early Onset Sepsis
- Neonatal Meningitis
- Neonatal Pneumonia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ampicillin + gentamicin | ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2011-01-01
- Completion
- 2012-01-01
- First posted
- 2012-07-04
- Last updated
- 2016-11-28
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT01633294. Inclusion in this directory is not an endorsement.