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

NCT ID: NCT04100252

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-09-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis)

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.

AFI via transabdominal ultrasonography

Intervention Type: OTHER

AFI via transabdominal ultrasonography was performed at the time of diagnosis.

Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis)

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.

AFI via transabdominal ultrasonography

Intervention Type: OTHER

AFI via transabdominal ultrasonography was performed at the time of diagnosis.

Interventions

AFI via transabdominal ultrasonography

AFI via transabdominal ultrasonography was performed at the time of diagnosis.

Intervention Type: OTHER

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Özkan Özdamar

M.D., Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medeniyet University, Goztepe Research and Training Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/0480

Identifier Type: -

Identifier Source: org_study_id