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Completed

NCT Number: NCT01633294

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

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.

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Key information

Conditions

Chorioamnionitis Adnexal Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endometritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Genital Diseases Genital Diseases, Female Infant, Newborn, Diseases Infections Inflammation Neonatal Early Onset Sepsis Neonatal Meningitis Neonatal Pneumonia Neonatal Sepsis Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Inflammatory Disease Placenta Diseases Pregnancy Complications Puerperal Endometritis Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Uterine Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ampicillin + gentamicin

Drug

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

Primary outcomes

  1. neonatal infection rate

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days

    neonatal infection rate includes early onset sepsis, meningitis and pneumonia

  2. maternal infection rate

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days

    maternal infection rate includes chorioamnionitis or puerperal endometritis

Secondary outcomes

  1. comparison of the infection rates between prompt and delayed induction

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days

    rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis

Sponsors and collaborators

Lead sponsor

Hospital de Santa Maria, Portugal

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jul 4, 2012
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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