Perinatal Outcome After Premature Rupture of Membranes

Overview

Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). When rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid volume (< 5 or >5).

Full Title of Study: “Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2012

Arms, Groups and Cohorts

  • Amniotic Fluid Volume > 5
    • Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index above 5.1
  • Amniotic Fluid Volume < 5
    • Pregnant patients with gestations between 24-34 weeks with premature rupture of membranes that, when the decision was made to interrupt the pregnancy, had amniotic fluid volume index of 5 or less.

Clinical Trial Outcome Measures

Primary Measures

  • Cesarean section rate
    • Time Frame: 5 months
    • Number of cases in each cohort that were interrupted by cesarean section due to fetal distress (evidence of cord dystocia).

Secondary Measures

  • Perinatal mortality
    • Time Frame: 5 months
    • Number of perinatal deaths (ante, peri and postpartum until 28 days postpartum)in each cohort.
  • Neonatal sepsis
    • Time Frame: 5 months
    • Number of cases of neonates diagnosed with sepsis in each cohort.

Participating in This Clinical Trial

Inclusion Criteria

  • Gestational age between 24-34 weeks.
  • Confirmed diagnosis of premature rupture of membranes.

Exclusion Criteria

  • Twin pregnancies.
  • Obstetric pathologies that require immediate termination of pregnancy (severe preeclampsia, abruptio placenta, cord prolapse).
  • Termination of pregnancy (whatever the reason) before complete corticoid treatment.
  • Incomplete recollection of all data required for analysis.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saint Thomas Hospital, Panama
  • Provider of Information About this Clinical Study
    • Principal Investigator: Osvaldo A. Reyes T., MD – Saint Thomas Hospital, Panama

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