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Related Publications & Presentations
Objective
To compare the frequency and pattern of uterine contractions
in patients who have a spontaneous preterm delivery with patients
who deliver at term. To evaluate predictive value of uterine
activity as measured by a home contraction monitor and other
screening tests for spontaneous preterm delivery.
Conclusion
Although risk of preterm birth less than 37 weeks rises with
increased uterine contraction frequency (UCF), UCF measured
between 24 and 36 weeks is a poor test to predict birth less
than 37 weeks.
Clinical Centers
Magee Womens, Tennessee, USC, Alabama, Wayne State,
Cincinnati Oklahoma, Bowman Gray, Chicago, Ohio State,
South Carolina
Major Eligibility Criteria
- Registering for prenatal care prior to 23 weeks
gestation
- Telephone in home
- Informed consent
Sample Size
- Goal = 300 evaluable singleton patients
- 230-250 singleton pregnancies with prior preterm
birth or second trimester vaginal bleeding who satisfy
minimum monitoring compliance criteria
- 50-70 low risk patients who satisfy minimum monitoring
compliance criteria
- Twin pregnancies enrolled without restrictions
Scheduled Evaluations/Data Collection
- Visit 1/3/5 (23/28/32 weeks):
- Questionnaire: demographic data, substance use, medical
and ob factors, anthropometrics
- Cervical exam
- Ultrasound for cervical parameters: length dilation,
station, position, consistency, membranes
- Specimen collection: fetal fibronectin, gram
stain for bacterial vaginosis, vaginal pH and KOH for
yeast
- Serum collection
- Visit 2/4/6 (26/30/34 weeks):
- Specimen collection: fetal fibronectin only
- Psychosocial questionnaire (visit 2 only)
- HUAM:
- Three times a week at 24, 25, 26 and 27 weeks
gestation
- Daily beginning at 28 weeks through 36 weeks
6 days
- Three time blocks: 04:00-11:59, 12:00-19:59;
20:00-3:59
- Labor and Delivery:
- Maternal and neonatal outcome
Outcome Measures
- Primary:
- Hourly contraction rate, by gestational age
- Secondary:
- Contraction pattern for five days preceding
preterm birth and each episode of preterm labor
- Frequency of preterm labor symptoms
- Self reported contraction frequency
- Spontaneous preterm delivery (< 37 weeks,
< 36 weeks, < 35 weeks, < 32 weeks)
Timetable (as of 5/96)
- Recruitment: 05/94-02/96
- Data Collection: 05/94-09/96
- Closeout/Final Analysis: 09/96-05/97
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