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

This study has been withdrawn prior to enrollment.
(Insufficient Funding)
Information provided by (Responsible Party):
david danon, Rabin Medical Center Identifier:
First received: February 4, 2010
Last updated: October 27, 2015
Last verified: October 2015
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
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

Resource links provided by NLM:

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 ]

Enrollment: 0
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


Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: david danon, Doctor, Rabin Medical Center Identifier: NCT01063686     History of Changes
Other Study ID Numbers: rmc-0191
Study First Received: February 4, 2010
Last Updated: October 27, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries processed this record on December 01, 2015