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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Delivery Preterm Birth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Preterm Delivery Multifetal pregnancy Preterm Birth 17-alpha Hydroxyprogesterone Caproate Markers of Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fetal Fibronectin

fFN test done during pregnancy

Intervention Type DEVICE

Salivary Estriol

Salivary Estriol done during pregnancy

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fFN SalEst

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kimberly Maurel, RN, MSN, CNS

Role: STUDY_DIRECTOR

Obstetrix Medical Group, Inc.

Richard Lee

Role: PRINCIPAL_INVESTIGATOR

Obstetrix Medical Group, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Desert Good Samaritan Hospital

Mesa, Arizona, United States

Site Status

Banner Good Sammaritan Hospital

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/0029-7844(96)00035-x.

Reference Type BACKGROUND

PMID: 8677060 (View on PubMed)

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. doi: 10.1136/bmj.294.6567.270.