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NCT01063686
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
NA trial testing insemination cervical cap in Fetal Membranes, Premature Rupture. Withdrawn.
Quick facts
| Lead sponsor | Rabin Medical Center |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Sites | 1 location across Israel |
Drugs / interventions tested
- insemination cervical cap
Conditions studied
- Fetal Membranes, Premature Rupture — all drugs for Fetal Membranes, Premature Rupture →
- Ultrasonography — all drugs for Ultrasonography →
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.
Verify or expand the search:
- PubMed search for NCT01063686
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01063686 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rabin Medical Center
- Last refreshed: 28 October 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01063686.
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