Perinatal Outcome After Premature Rupture of Membranes

Completed

• Conditions: Fetal Membranes; Premature Rupture

• Registration Number: NCT01538030
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-18
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Study Start: 2012-05
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cesarean section rate	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

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

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama