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

Primary Purpose

Fetal Membranes, Premature Rupture, Ultrasonography

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
insemination cervical cap
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Membranes, Premature Rupture focused on measuring Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Vaginal bleeding
  • Suspected chorioamnionitis

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Insemination cervical cap

Arm Description

Outcomes

Primary Outcome Measures

Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/

Secondary Outcome Measures

chorioamnionitis and abortion

Full Information

First Posted
February 4, 2010
Last Updated
October 27, 2015
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01063686
Brief Title
The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester
Official Title
Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient Funding
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Membranes, Premature Rupture, Ultrasonography
Keywords
Pregnancy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insemination cervical cap
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
insemination cervical cap
Other Intervention Name(s)
CERVICAL CUP pre-cut standard size, C.C.D. International., Ref. 12050IS, 48, rue des Petites Ecuries, 75010 Paris, France
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
chorioamnionitis and abortion
Time Frame
one week from the start of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age 14-23 Single fetus Suspected rupture of membranes Oligohydramnios Exclusion Criteria: Vaginal bleeding Suspected chorioamnionitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Danon, MD
Organizational Affiliation
Department of Ob/Gyn Rabin Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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