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

NCT04100252 | Completed

• 1 other identifier: 2018/0480
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Latency Time

  Through study completion, an average of 1 year

Study Arms (2)

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.

Other: AFI via transabdominal ultrasonography

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.

Other: AFI via transabdominal ultrasonography

Interventions

AFI via transabdominal ultrasonography OTHER

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

Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis); Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: All pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who were diagnosed as PPROM between 23+0 and 33+0 gestational ages.

You may qualify if:

• Pregnant women Diagnosis of PPROM between 23+0 and 33+0 gestational ages. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University, Goztepe Research and Training Hospital

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 24, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)