A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes

NCT ID: NCT01668472

Last Updated: 2013-12-23

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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®.

Conditions

Pregnant Woman With Premature Rupture of Amnion Membranes

Keywords

Pregnant; leaking fluid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colombo

OTHER

Sponsor Role: lead

Responsible Party

Professor Hemantha M. Senanayake

Professor, Department of Obstetrics and Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. M. Rajapaksha, MD

Role: STUDY_CHAIR

De Soysa Maternity Hospital, Kynsey Road, Colombo 08, Sri Lanka

Locations

University of Colombo, Department of Obstetrics and Gynecology, Labor and Delivery

Sri Jayewardenepura Kotte, Nubegeda, Sri Lanka

Countries

Sri Lanka

Other Identifiers

SriLankaROMStudy062012

Identifier Type: -

Identifier Source: org_study_id