Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

University of Saskatchewan

Status: Terminated

Conditions: Preterm Premature Rupture of Fetal Membranes

Study type: Observational

Funder types: Other

Identifiers

NCT01637610

11-67

Details and patient eligibility

About

The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for combination of pooling, nitrazine and ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).

Full description

Prior studies of AmniSure have included a heterogeneous population of women with preterm and term pregnancies.10-12 No study to date has specifically addressed and been powered to detect the efficacy of AmniSure in pregnancies between 16+0 and 36+6 weeks. The objective of the proposed research is to evaluate the usefulness of AmniSure PAMG-1 rapid immunoassay in the evaluation of preterm prelabour rupture of membranes (PPROM) compared to standard detection of PPROM with a speculum examination for combination of pooling, nitrazine and ferning.

Enrollment: 85 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation
• consent to enrollment

Exclusion criteria

• vaginal bleeding
• active labor (cervical dilation > 2 cm or effacement > 80%)
• multiple pregnancy
• fetal anomalies
• placenta previa
• fluid loss per vagina > 7 days
• prior inclusion in the study

Trial design

85 participants in 1 patient group

PPROM

Description:

All women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation.