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Perinatal Outcome After Premature Rupture of Membranes

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ClinicalTrials.gov Identifier: NCT01538030
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
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).

Condition or disease
Fetal Membranes Premature Rupture

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients between 24-34 weeks of gestation with a confirmed diagnosis of premature rupture of membranes.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538030


Locations
Panama
Saint Thomas H
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538030     History of Changes
Other Study ID Numbers: MHST2012-03
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Fetal membranes, premature rupture
Cesarean section
Perinatal mortality
Neonatal sepsis
Amniotic Fluid Volume

Additional relevant MeSH terms:
Premature Birth
Rupture
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries