The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes — AFI in PPROM  

Premature Rupture of Membrane Clinical Trial

Official title: The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 were examined for the inclusion criteria of the study. Among them, women with usual history of gross amniotic fluid leakage as well as classical speculum findings of ROM, such as pooling of amnitotic fluid within the posterior fornix or vaginal wall, were diagnosed as PPROM and included in the study without any further investigation. In case of the absence of these findings and suspected cases, PPROM was diagnosed via placental alpha-microglobulin-1 test from the vaginal fluid. Those with positive test results 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. ;

Related Conditions & MeSH terms

• Amniotic Fluid Leakage
• Fetal Complications
• Fetal Membranes, Premature Rupture
• Maternal Complication of Pregnancy
• Pregnancy Complications
• Premature Birth
• Premature Rupture of Membrane
• Rupture

• NCT number: NCT04100252
• Study type: Observational
• Source: Istanbul Medeniyet University
• Status: Completed
• Start date: September 1, 2018
• Completion date: September 1, 2019