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OpenTrials
Completed

NCT Number: NCT01538030

Perinatal Outcome After Premature Rupture of Membranes

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).

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Key information

Conditions

Fetal Membranes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Rupture Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Perinatal mortality

    Time frame: 5 months

    Number of perinatal deaths (ante, peri and postpartum until 28 days postpartum)in each cohort.

  2. Neonatal sepsis

    Time frame: 5 months

    Number of cases of neonates diagnosed with sepsis in each cohort.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Aug 15, 2012

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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