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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01063686
First received: February 4, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Fetal Membranes, Premature Rupture
Ultrasonography
Device: insemination cervical cap

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/ [ Time Frame: the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • chorioamnionitis and abortion [ Time Frame: one week from the start of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Arms Assigned Interventions
No Intervention: Insemination cervical cap Device: insemination cervical cap
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.
Other Names:
  • CERVICAL CUP pre-cut standard size, C.C.D. International.
  • Ref. 12050IS
  • 48, rue des Petites Ecuries
  • 75010 Paris
  • France

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Vaginal bleeding
  • Suspected chorioamnionitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063686

Contacts
Contact: David Danon, MD 972504065316 davidd3@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel
Contact: David Danon, MD    972504065316    davidd3@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: David Danon, MD Department of Ob/Gyn Rabin Medical Center, Israel
  More Information

No publications provided

Responsible Party: David Danon MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01063686     History of Changes
Other Study ID Numbers: rmc-0191
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Pregnancy

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014