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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063686

Enrollment

Registered

2010-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Membranes, Premature Rupture, Ultrasonography

Keywords

Pregnancy

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.

Interventions

DEVICEinsemination 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Vaginal bleeding * Suspected chorioamnionitis

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
chorioamnionitis and abortion	one week from the start of the study

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026