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

Ultrasonography Clinical Trial

Official title:

Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01063686
• Other study ID #: rmc-0191
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2010
• Last updated: October 27, 2015

Study information

• Verified date: October 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gestational age 14-23

• Single fetus

• Suspected rupture of membranes

• Oligohydramnios

Exclusion Criteria:

• Vaginal bleeding

• Suspected chorioamnionitis

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Rupture
• Ultrasonography

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in amniotic fluid index and single vertical pocket before and after placement of the cervical cap/		the parameters will be measured before placement, 6 hours after placement, 1 hour after displacement	No
Secondary	chorioamnionitis and abortion		one week from the start of the study	Yes