The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
- Conditions
- Fetal Membranes, Premature RuptureUltrasonography
- Interventions
- Device: insemination cervical cap
- Registration Number
- NCT01063686
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Gestational age 14-23
- Single fetus
- Suspected rupture of membranes
- Oligohydramnios
- Vaginal bleeding
- Suspected chorioamnionitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insemination cervical cap insemination cervical cap -
- Primary Outcome Measures
Name Time Method Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/ the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement
- Secondary Outcome Measures
Name Time Method chorioamnionitis and abortion one week from the start of the study
Trial Locations
- Locations (1)
Rabin Medical Center
🇮🇱Petah Tikva, Israel