NCT02208011

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. Inclusion Criteria:

  • English speaking
  • pregnant woman \>15 weeks gestation undergoing an exam for ruptured membranes Exclusion Criteria:
  • Known placental previa
  • Active vaginal bleeding

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 1, 2014

Last Update Submit

August 31, 2020

Conditions

Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Outcome Measures

Primary Outcomes (1)

  • evidence of ruptured membranes

    up to delivery of infant

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.

You may qualify if:

  • complaint of ruptured membranes
  • IUP \> 15 weeks gestation
  • English speaking, over the age of 18yrs old

You may not qualify if:

  • active bleeding
  • placenta previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

Related Publications (1)

  • Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y.

    PMID: 28446135DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 4, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

US(1)