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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Premature Rupture of Membrane, Amniotic Fluid Leakage, Maternal Complication of Pregnancy, Fetal Complications

Intervention / Treatment
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* Other: AFI via transabdominal ultrasonography


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis)<br>Pregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI<5 were enrolled in the Group 1. | Other: AFI via transabdominal ultrasonography<br>* AFI via transabdominal ultrasonography was performed at the time of diagnosis.<br>|
| Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis)<br>Pregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI≥5 were enrolled in the Group 2. | Other: AFI via transabdominal ultrasonography<br>* AFI via transabdominal ultrasonography was performed at the time of diagnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency Time | The time period from the PPROM diagnosis to delivery. | Through study completion, an average of 1 year |