fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo

This study has been withdrawn prior to enrollment.
(This study was stopped because of insufficient enrollment.)
Sponsor:
Collaborator:
Adeza Biomedical
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT00156000
First received: September 8, 2005
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Preterm Delivery
Preterm Birth
Device: Fetal Fibronectin
Device: Salivary Estriol
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Obstetrix Medical Group:

Enrollment: 0
Study Start Date: August 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fetal Fibronectin
    fFN test done during pregnancy
    Other Name: fFN
    Device: Salivary Estriol
    Salivary Estriol done during pregnancy
    Other Name: SalEst
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 risen 25% in the United States over the last two decades. Women with multi-fetal pregnancies are at especially high risk of preterm birth. About half of twin pregnancies and almost all triplet pregnancies result in preterm birth. Thus, women with multi-fetal gestations appear to be a group that would benefit most from a screening intervention to determine those pregnancies at greatest risk for preterm birth. Currently, two biochemical, diagnostic tests for preterm birth are approved by the FDA: fetal fibronectin and salivary estriol testing. Recent studies have shown that weekly administration of 17-alpha-hydroxyprogesterone significantly reduced preterm delivery in singleton pregnancies. The proposed study will assist in the assessment of women who will benefit most from progesterone injections by clarifying it's mechanism of action through the evaluation of serial fFN and E3 samples in a subset of women currently enrolled in a multi-center trial evaluating 17-alpha-hydroxyprogesterone caproate in twin and triplet pregnancies.

This is a prospective observational study following the results of serial fetal fibronectin and salivary estriol samples in a subpopulation of women with twin pregnancies currently enrolled in a primary trial of weekly injections of 17-alpha-hydroxyprogesterone caproate versus placebo injections. Subjects will be recruited from a large perinatology practice consisting of four outpatient clinics in the Phoenix metropolitan area.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women (Twins or Triplets) already enrolled in the Obstetrix Clinical Trial " Progesterone for prevention of PTB in twin and triplet pregnancies"

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156000

Locations
United States, Arizona
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Obstetrix Medical Group
Adeza Biomedical
Investigators
Study Director: Kimberly Maurel, RN, MSN, CNS Obstetrix Medical Group, Inc.
Principal Investigator: Richard Lee Obstetrix Medical Group, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00156000     History of Changes
Other Study ID Numbers: OBX0048.2
Study First Received: September 8, 2005
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
Preterm Delivery
Multifetal pregnancy
Preterm Birth
17-alpha Hydroxyprogesterone Caproate
Markers of Preterm Birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on July 29, 2014