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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insemination cervical cap | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insemination cervical cap | Device | Primary abdominal ultrasound (US) for amniotic fluid index (AFI), Single vertical pocket, and dimensions of pocket below the presenting part. Speculum vaginal examination. In a sterile manner a cervical cap is adjusted on the cervix. the patient is kept recumbent for 6 hours. A repeat US exam is performed. The cervical cap is removed. After one hour another US is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| chorioamnionitis and abortion | one week from the start of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Danon, MD | Department of Ob/Gyn Rabin Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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