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

Overview

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.

Full Title of Study: “Use of a Cervical Cap as an Aid in Uncertain Rupture of Membranes in the Second Trimester”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Insemination cervical cap

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

  • chorioamnionitis and abortion
    • Time Frame: one week from the start of the study

Participating in This Clinical Trial

Inclusion Criteria

  • Gestational age 14-23 – Single fetus – Suspected rupture of membranes – Oligohydramnios Exclusion Criteria:

  • Vaginal bleeding – Suspected chorioamnionitis

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: david danon, Doctor – Rabin Medical Center
  • Overall Official(s)
    • David Danon, MD, Principal Investigator, Department of Ob/Gyn Rabin Medical Center, Israel

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