Perinatal Outcome After Premature Rupture of Membranes

August 13, 2012 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas H

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant patients between 24-34 weeks of gestation with a confirmed diagnosis of premature rupture of membranes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 18, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2012-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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