Status:
WITHDRAWN
fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Lead Sponsor:
Obstetrix Medical Group
Collaborating Sponsors:
Adeza Biomedical
Conditions:
Preterm Delivery
Preterm Birth
Eligibility:
FEMALE
18-60 years
Brief Summary
Among women with a twin pregnancy, currently enrolled in a study in which they are receiving weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal fibronectin (fF...
Detailed Description
Preterm birth occurs in approximately 12% of all pregnancies in the United States and is the leading cause of neonatal morbidity and mortality. Despite extensive efforts the preterm birth rate has ris...
Eligibility Criteria
Inclusion
- Patients with twin pregnancies currently participating in the ongoing IRB approved multicenter trial entitled 17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity due to Preterm Birth in Twin and Triplet Pregnancy.
- GA at time of enrollment between 16w0d weeks gestation and 23w6d gestation)
- Maternal age 18 years or older
- Intact amniotic membranes
- Investigator believes patient will be reliable with follow-up visits and believes that delivery data \& neonatal data are likely to be available.
- Subject has voluntarily signed and dated an IRB approved informed consent form prior to any participation in the study
Exclusion
- Symptomatic uterine contractions at time of enrollment
- Placenta previa
- Abruptio placenta
- Severe preeclampsia
- Digital examination within 24 hours prior to the fFN sample collection
- Vaginal intercourse within 24 hours prior to the fFN sample collection
- Transvaginal ultrasound or vaginal speculum exam within 24 hours prior to fFN sample collection
- Amniocentesis within 24 hours prior to fFN sample collection
- Moderate or gross vaginal bleeding at the time of fFN sample collection
- Cervical cerclage
- Advanced cervical dilatation ≥ 3 cm
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00156000
Start Date
August 1 2005
End Date
February 1 2006
Last Update
December 19 2014
Active Locations (2)
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1
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
2
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006