Preterm Birth Clinical Trial
Official title:
Fetal Fibronectin (fFN) and Salivary Estriol (E3) in the Prediction of Preterm Birth in Women With Twin Pregnancies Receiving 17-Alpha-Hydroxyprogesterone Caproate or Placebo
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 (fFN) and salivary estriol (E3 ) will identify the following.
1. Women at increased risk for preterm delivery.
2. A subpopulation, among those receiving the active drug, who may respond to
progesterone.
If fFN and/or E3 identify a population of patients who respond to progesterone, these
diagnostic tests may define women who may or may not be good candidates for progesterone
therapy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2006 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. GA at time of enrollment between 16w0d weeks gestation and 23w6d gestation) 3. Maternal age 18 years or older 4. Intact amniotic membranes 5. Investigator believes patient will be reliable with follow-up visits and believes that delivery data & neonatal data are likely to be available. 6. Subject has voluntarily signed and dated an IRB approved informed consent form prior to any participation in the study Exclusion Criteria: 1. Symptomatic uterine contractions at time of enrollment 2. Placenta previa 3. Abruptio placenta 4. Severe preeclampsia 5. Digital examination within 24 hours prior to the fFN sample collection 6. Vaginal intercourse within 24 hours prior to the fFN sample collection 7. Transvaginal ultrasound or vaginal speculum exam within 24 hours prior to fFN sample collection 8. Amniocentesis within 24 hours prior to fFN sample collection 9. Moderate or gross vaginal bleeding at the time of fFN sample collection 10. Cervical cerclage 11. Advanced cervical dilatation = 3 cm |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Desert Good Samaritan Hospital | Mesa | Arizona |
United States | Banner Good Sammaritan Hospital | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Obstetrix Medical Group | Adeza Biomedical |
United States,
Darne J, McGarrigle HH, Lachelin GC. Increased saliva oestriol to progesterone ratio before preterm delivery: a possible predictor for preterm labor? Br Med J (Clin Res Ed). 1987 Jan 31;294(6567):270-2. — View Citation
Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network. Obstet Gynecol. 1996 May;87(5 Pt 1):643-8. — View Citation
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