Fetal Membranes Clinical Trial
Official title:
Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.
| Verified date | August 2012 |
| Source | Saint Thomas Hospital, Panama |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Panama: Ministry of Health |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | August 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Panama | Saint Thomas H | Panama |
| Lead Sponsor | Collaborator |
|---|---|
| Saint Thomas Hospital, Panama |
Panama,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cesarean section rate | Number of cases in each cohort that were interrupted by cesarean section due to fetal distress (evidence of cord dystocia). | 5 months | No |
| Secondary | Perinatal mortality | Number of perinatal deaths (ante, peri and postpartum until 28 days postpartum)in each cohort. | 5 months | No |
| Secondary | Neonatal sepsis | Number of cases of neonates diagnosed with sepsis in each cohort. | 5 months | No |