NCT00156000

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. 1.Women at increased risk for preterm delivery.
  2. 2.A subpopulation, among those receiving the active drug, who may respond to progesterone.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2005

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

September 8, 2005

Last Update Submit

December 17, 2014

Conditions

Preterm DeliveryPreterm Birth

Keywords

Preterm DeliveryMultifetal pregnancyPreterm Birth17-alpha Hydroxyprogesterone CaproateMarkers of Preterm Birth

Interventions

Fetal FibronectinDEVICE

fFN test done during pregnancy

Also known as: fFN
Salivary EstriolDEVICE

Salivary Estriol done during pregnancy

Also known as: SalEst

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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"

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Desert Good Samaritan Hospital

Mesa, Arizona, 85202, United States

Location

Banner Good Sammaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Related Publications (2)

  • 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.

    PMID: 8677060BACKGROUND

  • 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.

    PMID: 3101838BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kimberly Maurel, RN, MSN, CNS

    Obstetrix Medical Group, Inc.

    STUDY DIRECTOR

  • Richard Lee

    Obstetrix Medical Group, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

US(2)