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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063686
Recruitment Status : Withdrawn (Insufficient Funding)
First Posted : February 5, 2010
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
david danon, 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.

Condition or disease Intervention/treatment Phase
Fetal Membranes, Premature Rupture Ultrasonography Device: insemination cervical cap Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. chorioamnionitis and abortion [ Time Frame: one week from the start of the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Vaginal bleeding
  • Suspected chorioamnionitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063686

Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: David Danon, MD Department of Ob/Gyn Rabin Medical Center, Israel

Responsible Party: david danon, Doctor, Rabin Medical Center Identifier: NCT01063686     History of Changes
Other Study ID Numbers: rmc-0191
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by david danon, Rabin Medical Center:

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