Clinical trial NCT01668472: A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes
Official title: A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnant Woman With Premature Rupture of Amnion Membranes
Keywords: Pregnant
leaking fluid
Lead sponsor: University of Colombo
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pregnant woman who presents with alleged leakage of amniotic fluid is eligible for recruitment

Brief summary: Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.

Detailed description: Premature rupture of membranes (PROM), defined as spontaneous rupture of membranes (ROM) before the onset of uterine contractions, is one of the most common diagnostic dilemmas in contemporary obstetric practice. Premature rupture of membranes can occur at any gestational age, and preterm PROM (PPROM, defined as PROM before 37 weeks) is responsible for 20-40% of preterm births. Early and accurate diagnosis of PROM would allow for gestational age-specific obstetric interventions designed to optimize perinatal outcome and minimize serious complications such as cord prolapse, preterm delivery, fetal distress and infectious morbidity (chorioamnionitis, neonatal sepsis). Conversely, a false-positive diagnosis of PROM may lead to unnecessary obstetric interventions, including hospitalization, administration of antibiotics and corticosteroids, and even induction of labor. Therefore, the correct and timely diagnosis of this disorder is of critical importance to the clinician because PROM and PPROM may be associated with serious maternal and neonatal consequences.

The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment. First, by speculum examination, the clinician looks for amniotic fluid leaking from the cervical os. If clear fluid is visualized leaking from the cervical os, the diagnosis is positive for fetal membrane rupture. More commonly, leaking is absent, and a more extensive workup is required, which includes nitrazine/pH testing, visual inspection of pooling of fluid in the posterior fornix, and a microscopic evaluation of the collected specimen (ferning). Although this approach is considered the standard of care, it is fraught with inaccuracies, requires an intrusive examination and may not provide a rapid diagnosis.

Rapid, point of care, qualitative immunochromatographic tests (ie., Amnisure®, ActimProm®, Amnioquick®) that detect proteins found in amniotic fluid at high concentrations, have been used to diagnose the rupture of membranes (ROM) for several years. In many hospitals, Amnisure® has replaced the sterile speculum exam as the standard of care for diagnosing ROM. It identifies Placental Alpha Microglobulin-1 (PAMG-1), a 34 kd fetal glycoprotein, in cervicovaginal secretions.

Recently a new, rapid, point of care, qualitative immunochromatographic test was introduced to the market, ROM Plus®. Unlike the other immunoassay tests, ROM Plus® uses a unique monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations. ROM Plus® detects Placental Protein-12 (also known as Insulin-like Growth Factor Binding Protein-1) as well as Alpha Fetoprotein (AFP). The combination of PP12 and AFP were chosen not only because of their robust historical literature support as ideal protein markers for amniotic fluid5-22, but also their unique characteristics. PP12 is synthesized by the decidua of the placenta and reaches a very high concentration level in the amniotic fluid early in the first trimester and stays at that level until delivery. However, AFP, synthesized by the fetal liver and yolk sac, reaches its peak concentration late in the second trimester/early third trimester. This increases the chance that the proteins will be detected, especially in the preterm patients, when the diagnosis of ROM is most crucial.

This study is designed to assess the performance (sensitivity, specificity, PPV, NPV) of ROM Plus® and Amnisure®.

Eligibility criteria: PARTICIPANT SELECTION CRITERIA:

Inclusion Criteria:

• Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment

Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding

Primary outcomes:
measure: This study is designed to determine number of participants with rupture of membranes from clinical assessment.
timeFrame: From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)
Secondary outcomes:
measure: Results of AmniSure test.
timeFrame: From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)
measure: Results of ROM PLus Test
timeFrame: From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)
Other outcomes:
Locations:
city: Sri Jayewardanepura Kotte
country: Sri Lanka
facility: University of Colombo, Department of Obstetrics and Gynecology, Labor and Delivery
state: Nubegeda
Study officials:
affiliation: De Soysa Maternity Hospital, Kynsey Road, Colombo 08, Sri Lanka
name: Dr. M. Rajapaksha, MD
role: STUDY_CHAIR
References: