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CompletedNCT01633294Updated Nov 28, 2016

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

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

Phase
Phase 2/3
Study type
Interventional
Enrollment
161
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Chorioamnionitis
  • Puerperal Endometritis
  • Neonatal Early Onset Sepsis
  • Neonatal Meningitis
  • Neonatal Pneumonia

Keywords

  • premature rupture of membranes
  • term pregnancy
  • chorioamnionitis
  • endometritis
  • neonatal sepsis
  • antibiotic prophylaxis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Active comparator
    Antibiotic group

    women submitted to antibiotic prophylaxis

    Drug: Ampicillin + gentamicin

  • No intervention
    Control group

Interventions

  • DrugAmpicillin + gentamicin

    ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

06

Study locations

1 site
  • Hospital Santa Maria
    Lisboa, 1649-035, Portugal
07

References and documents

Publications

  • Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc. PubMed 23090521 ↗
08

Registry details

Key details

Study ID
NCT01633294
Lead sponsor
Hospital de Santa Maria, Portugal
Responsible party
Filipa Faria Vaz Passos (Principal investigator, Hospital de Santa Maria, Portugal) — Principal investigator
First posted
Jul 4, 2012
Start date
Oct 2008
Primary completion
Jan 2011
Completion
Jan 2012
Last update
Nov 28, 2016

Study contacts

Filipa Faria Vaz Passos, Dr
principal investigator · Santa Maria Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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