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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156000
Recruitment Status : Withdrawn (This study was stopped because of insufficient enrollment.)
First Posted : September 12, 2005
Last Update Posted : December 19, 2014
Adeza Biomedical
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )

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 (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 or disease Intervention/treatment
Preterm Delivery Preterm Birth Device: Fetal Fibronectin Device: Salivary Estriol

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.

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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : August 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Fetal Fibronectin
    fFN test done during pregnancy
    Other Name: fFN
  • Device: Salivary Estriol
    Salivary Estriol done during pregnancy
    Other Name: SalEst

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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"

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156000

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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
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Study Director: Kimberly Maurel, RN, MSN, CNS Obstetrix Medical Group, Inc.
Principal Investigator: Richard Lee Obstetrix Medical Group, Inc.

Additional Information:
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Responsible Party: Obstetrix Medical Group Identifier: NCT00156000    
Other Study ID Numbers: OBX0048.2
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group ):
Preterm Delivery
Multifetal pregnancy
Preterm Birth
17-alpha Hydroxyprogesterone Caproate
Markers of Preterm Birth
Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs