Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Chorioamnionitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633294
• Other study ID #: 335/08 - 28/07/08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 23, 2012
• Last updated: November 24, 2016
• Start date: October 2008
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Hospital de Santa Maria, Portugal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chorioamnionitis
• Endometritis
• Fetal Membranes, Premature Rupture
• Meningitis
• Neonatal Early Onset Sepsis
• Neonatal Meningitis
• Neonatal Pneumonia
• Pneumonia
• Puerperal Endometritis
• Rupture
• Sepsis

Intervention

Drug:
• Ampicillin + gentamicin
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously

Locations

Country	Name	City	State
Portugal	Hospital Santa Maria	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Santa Maria, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal infection rate	neonatal infection rate includes early onset sepsis, meningitis and pneumonia	participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Primary	maternal infection rate	maternal infection rate includes chorioamnionitis or puerperal endometritis	participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	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	participants will be followed for the duration of hospital stay, an expected average of 3 days	No