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

NCT ID: NCT01063686

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Fetal Membranes, Premature Rupture; Ultrasonography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Insemination cervical cap

Group Type: NO_INTERVENTION

insemination cervical cap

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

CERVICAL CUP pre-cut standard size, C.C.D. International.; Ref. 12050IS; 48, rue des Petites Ecuries; 75010 Paris; France

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Vaginal bleeding
• Suspected chorioamnionitis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

david danon

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Danon, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ob/Gyn Rabin Medical Center, Israel

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

rmc-0191

Identifier Type: -

Identifier Source: org_study_id