To assess the efficacy of the novel kit for the detection of PAMG-1 in the cervico-vaginal secretions of pregnant women with clinically intact membranes presenting with signs and symptoms of PTL in predicting time-to-delivery.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
SN, SP, PPV, and NPV for the novel kit for the detection of PAMG-1, cervical
length measurements by trans-vaginal ultrasound (<30 mm), cervical dilatation >
1 cm, and contraction frequency >= 8 per hour for the following
presentation-to-delivery time intervals:
a. <= 48 hours
b. <= 7 days
c. <= 14 days
Secondary outcome
2. Association between results of the above tests and the following outcomes:
a. Delivery <37 weeks gestation
b. Admission to NICU
c. Histological chorioamnionitis
d. Funisitis
e. Respiratory distress syndrome
f. Patent ductus arteriosus
g. Neonatal sepsis
h. Birthweight
i. Perinatal death
Background summary
Accordingly, a device that is more sensitive in its detection of PAMG-1 than
the AmniSure® ROM Test presumably will be able to detect more patients at risk
for imminent delivery than its predecessor in patients presenting to labor and
delivery units with signs, symptoms or complaints suggestive of preterm labor
(PTL) who have no clinical evidence of membrane rupture. If this is the case,
this tool may be of significant value to the provider in deciding how to manage
their patients suspected to be at risk for imminent delivery. Management
options may include administration of tocolytics to prolong gestation,
corticosteroids to improve respiratory development, administration of
antibiotics to decrease the risk of infection (intra-partum and post-partum),
prescription of bed rest, as well as increased observation and fetal monitoring
Study objective
To assess the efficacy of the novel kit for the detection of PAMG-1 in the
cervico-vaginal secretions of pregnant women with clinically intact membranes
presenting with signs and symptoms of PTL in predicting time-to-delivery.
Study design
This is a prospective observational trial that will enroll pregnant women
between 200/7 and 366/7 weeks of gestation that present with signs and symptom
of preterm labor with clinically intact membranes and cervical dilatation <3 cm
to assess how the results of novel kit for the detection of PAMG-1 in this
patient group correlates to their time-to-delivery (TTD) and other adverse
neonatal and pregnancy outcomes.
Study burden and risks
There is no potential conflict of interest. None of the investigators stand to
benefit financially in any way, either directly or indirectly, from this study.
There are no additional potential risks involved in this study. The study
involves only one additional clinical evaluation. Preterm labor/imminent
delivery will be clinically diagnosed in accordance with accepted practices.
The results of the novel kit for the detection of PAMG-1 will not be applied
toward clinical decision making in this study.
Oudelaan 1
Zuidbroek 9636 AE
NL
Oudelaan 1
Zuidbroek 9636 AE
NL
Listed location countries
Age
Inclusion criteria
signs and symptoms or complaints suggestive of preterm labor (PTL)
gestational age between 20 and 37 weeks
< 3 cm cervical dilatation
consenting to be part of tghe trial
Exclusion criteria
Rupture of fetal membranes (ROM)
receiving tocolytic medication prior collection of cervicovaginal specimens
cervical dilatation > 3 cm
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46920.098.13 |