NCT04100252: AFI in PPROM

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

Completed Last updated 24 September 2019

What this trial tests

trial testing AFI via transabdominal ultrasonography in Premature Rupture of Membrane in 48 participants. Completed in 1 September 2019.

Timeline

1 September 2018

Primary endpoint
1 September 2019

1 September 2019

Quick facts

Lead sponsor	Istanbul Medeniyet University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	48
Start date	1 September 2018
Primary completion	1 September 2019
Estimated completion	1 September 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• AFI via transabdominal ultrasonography

Conditions studied

• Premature Rupture of Membrane — all drugs for Premature Rupture of Membrane →
• Amniotic Fluid Leakage — all drugs for Amniotic Fluid Leakage →
• Maternal Complication of Pregnancy — all drugs for Maternal Complication of Pregnancy →
• Fetal Complications — all drugs for Fetal Complications →

Sponsor

Istanbul Medeniyet University

Who can join

Adults 18 to 40, female only, with Premature Rupture of Membrane or Amniotic Fluid Leakage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.