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

Clalit Health Services

Status: Withdrawn

Conditions: Ultrasonography; Fetal Membranes, Premature Rupture

Treatments: Device: insemination cervical cap

Study type: Interventional

Funder types: Other

Identifiers

NCT01063686

rmc-0191

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age 14-23
• Single fetus
• Suspected rupture of membranes
• Oligohydramnios

Exclusion criteria

• Vaginal bleeding
• Suspected chorioamnionitis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Insemination cervical cap

No Intervention group

Treatment:

Device: insemination cervical cap