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

NCT01063686 | Withdrawn DMC

• 1 other identifier: rmc-0191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• chorioamnionitis and abortion

  one week from the start of the study

Study Arms (1)

Insemination cervical cap

NO INTERVENTION

Device: insemination cervical cap

Interventions

insemination cervical cap 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.

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

Insemination cervical cap

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Vaginal bleeding
• Suspected chorioamnionitis

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• David Danon, MD

  Department of Ob/Gyn Rabin Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

IL (1)