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

NCT01668472 | Withdrawn DMC

• 1 other identifier: SriLankaROMStudy062012
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Woman With Premature Rupture of Amnion Membranes

Keywords

Pregnant; leaking fluid

Outcome Measures

Primary Outcomes (1)

• This study is designed to determine number of participants with rupture of membranes from clinical assessment.

  The standard of care is to perform a sterile speculum exam and noting the evidence of leakage of fluid from the cervical os, and if necessary, pooling of fluid in the posterior fornix, assessing the fluid with nitrazine/pH and ferning under the microscope. The following chart review criteria will be assessed: Major Criteria * the results of the initial SSE (leaking, pooling, ferning, nitrazine) and any follow-up SSE * the AFI using ultrasound assessment * the number of hours from the initial exam to delivery (\<48 hours will be considered suggestive of ROM) * evidence of chorioamnionitis and/or endomyometritis

  From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)

Secondary Outcomes (2)

• Results of AmniSure test.

  From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)

• Results of ROM PLus Test

  From hospital presentation on complaint of leaking fluid to delivery estimated to be less than 30 days. (up to 30 days)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Known placental previa
• Active vaginal bleeding

Sponsors & Collaborators

• University of Colombo: lead

Study Sites (1)

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

Sri Jayewardenepura Kotte, Nubegeda, 168/12, Sri Lanka

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample of diluted vaginal secretion into buffer

Study Officials

• Dr. M. Rajapaksha, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

SR (1)