Premature Rupture of Membrane Clinical Trial
— AFI in PPROMOfficial title:
The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM)
Verified date | September 2019 |
Source | Istanbul Medeniyet University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Pregnant women who admitted with the complaint of amniotic fluid leakage between the
gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in
the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission,
hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios,
and those who declined to involve in the study were excluded.
In all included women were examined at the admission for amniotic fluid index via trans
abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the
deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All
included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm.
Included patients were followed in terms of maternal and fetal complications. Maternal
complications were chorioamnionitis, placental abruption, placental retention, postpartum
endometritis, postpartum hemorrhage; while fetal complications comprised necessity of
admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome,
respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10,
APGAR score of 5th minute below 5. All complication rates were compared between the groups.
In addition, the time period between the diagnosis of PPROM and the time of delivery was
defined as latency period and were compared between the groups.
Status | Completed |
Enrollment | 48 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: Pregnant women Diagnosis of PPROM between 23+0 and 33+0 gestational ages. - Exclusion Criteria: Multiple gestations, C Cervical dilatation above 6 cm at the admission, Hypertensive diseases, Cervical cerclage, Fetal anomalies, Oligohydramnios, Polihydramnios, Those who declined to participate in the study. - |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medeniyet University, Goztepe Research and Training Hospital | Istanbul | Kadikoy |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medeniyet University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Pregnant Women experiencing Complications | Adverse events emerging in included pregnant women from the time of PPROM diagnosis to the end of the postpartum 1st month | Through study completion, an average of 1 year | |
Primary | Number of fetuses and newborns experiencing complications | Adverse events emerging in fetuses and neonates from the time of PPROM diagnosis to the end of the postpartum 1st month | Through study completion, an average of 1 year | |
Secondary | Latency Time | The time period from the PPROM diagnosis to delivery. | Through study completion, an average of 1 year |
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