An observational study in Premature Rupture of Membrane, Amniotic Fluid Leakage and Maternal Complication of Pregnancy, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by Istanbul Medeniyet University · 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.
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.
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This study's enrollment of 48 is below the median of 112 across 777 observational studies indexed under Premature Birth.
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Pregnant women who were diagnosed as PPROM between 23+0 and 33+0 gestational ages.
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.
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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
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
AFI via transabdominal ultrasonography was performed at the time of diagnosis.
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
Time frame: 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
Time frame: Through study completion, an average of 1 year
Latency Time
The time period from the PPROM diagnosis to delivery.
Time frame: Through study completion, an average of 1 year
Plan to share: Yes — To be assessed
Supporting information: Study protocol, Csr
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Istanbul Medeniyet University