Perinatal Outcome After Premature Rupture of Membranes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01538030
First received: February 18, 2012
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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
Fetal Membranes
Premature Rupture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Cesarean section rate [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Number of cases in each cohort that were interrupted by cesarean section due to fetal distress (evidence of cord dystocia).


Secondary Outcome Measures:
  • Perinatal mortality [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Number of perinatal deaths (ante, peri and postpartum until 28 days postpartum)in each cohort.

  • Neonatal sepsis [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Number of cases of neonates diagnosed with sepsis in each cohort.


Enrollment: 80
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01538030

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

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538030     History of Changes
Other Study ID Numbers: MHST2012-03
Study First Received: February 18, 2012
Last Updated: August 13, 2012
Health Authority: Panama: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014