Trial Outcomes & Findings for Analysis of ROM Plus to Detect Rupture of Membranes (NCT NCT01366443)

Results Overview

Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.

Recruitment status

COMPLETED

Target enrollment

288 participants

Primary outcome timeframe

1 week

Results posted on

2012-07-31

Participant Flow

Patients recruited from July 2010 to May 2011 at three Medical Hospitals, Departments of Obstetric and Gynecology Labor and Delivery Wards.

No particpants were excluded that matched the particpant enrollment of evaluation for suspicion of rupture of amniotic membranes by standard speculum examination for cervical leaking, pooling, ferning and nitrazine.

Participant milestones

Participant milestones
Measure	Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Overall Study STARTED	288
Overall Study COMPLETED	285
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Overall Study Lost to Follow-up	2
Overall Study Under 18 yo	1

Baseline Characteristics

Analysis of ROM Plus to Detect Rupture of Membranes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Pregnant n=288 Participants Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	287 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	27.26 years STANDARD_DEVIATION 5.81 • n=5 Participants
Sex: Female, Male Female	288 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	288 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.

Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.

Outcome measures

Outcome measures
Measure	Pregnant Women (Clinical Assessment vs. Chart Review) n=285 Participants This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.	Pregnant Women (ROM Plus vs. Chart Review) n=285 Participants This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus True Negative Membrane Rupture	95 participants Interval 0.97 to 1.0	88 participants
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus True Positive Membrane Rupture	160 participants	187 participants
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus False Negative Membrane Rupture	2 participants	9 participants
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus False Positive Membrane Rupture	28 participants	1 participants

Adverse Events

Women Pregnant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Draper, MD University of Utah Medical Center, Dept. of OB/GYN

University of Utah Medical Center, Dept. of OB/GYN

Phone: 801-581-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place