Perinatal Outcome After Premature Rupture of Membranes
This study has been completed.
Sponsor:
Saint Thomas Hospital, Panama
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
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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 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 May 21, 2013