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

Sponsor:	Obstetrix Medical Group
Collaborator:	Adeza Biomedical
Information provided by:	Obstetrix Medical Group
ClinicalTrials.gov Identifier:	NCT00156000

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.

Women at increased risk for preterm delivery.
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 I

Study Type:	Observational
Study Design:	Cohort, 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:

Drug Information available for: Estriol 17-Hydroxyprogesterone 16-Epiestriol Hydroxyprogesterone caproate

U.S. FDA Resources

Further study details as provided by Obstetrix Medical Group:

Biospecimen Retention: None Retained

Biospecimen Description:

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:

fFN test done during pregnancy

Salivary Estriol done during pregnancy

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:

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 Criteria:

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

Contacts and Locations

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

Locations

United States, Arizona
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202

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:

Protocols' home page on the sponsor's Web site. Click on Protocols and then click the fFN & Sal Est Protocol for more information about this study. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Responsible Party:	Obstetrix Medical Group, Inc. ( Kimberly Maurel )
Study ID Numbers:	OBX0048.2
Study First Received:	September 8, 2005
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00156000 History of Changes
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:

Estrogen Antagonists
Pregnancy Complications
Hormone Antagonists
Obstetric Labor, Premature
Physiological Effects of Drugs
Obstetric Labor Complications
Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones
17-alpha-hydroxy-progesterone caproate
Pharmacologic Actions
Estrogen Receptor Modulators
Progestins
Estradiol Antagonists
Premature Birth

ClinicalTrials.gov processed this record on February 08, 2010