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NCT01063686

The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester

Withdrawn NA Last updated 28 October 2015
What this trial tests

NA trial testing insemination cervical cap in Fetal Membranes, Premature Rupture. Withdrawn.

Quick facts

Lead sponsorRabin Medical Center
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

Adults 18 to 50, female only, with Fetal Membranes, Premature Rupture or Ultrasonography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Early preterm premature rupture of membranes (PPROM) complicates 0.7% of pregnancies. When PPROM occurs before the 24th week,the risk of fetal and neonatal death is 70%. There is also a high risk of neonatal and maternal morbidity. When the diagnosis of PPROM is uncertain by physical examination, additional tests are needed. These tests have false positive and false negative rates. The gold standard for diagnosing PPROM is amniocentesis and dye test. This procedure has a risk of infection and abortion.Our hypothesis is that by using a cervical cap for 6 hours and repeated ultrasound exams we can diagnose or rule out PPROM in cases which are uncertain. Our study group will be pregnant women gestational age 14-23, suspected of having PPROM.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Rabin Medical Center trials

Trials by the same sponsor.

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