fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Withdrawn before enrolling
Conditions studied: Preterm Delivery, Preterm Birth
In brief
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.
Key facts
- Study ID
- NCT00156000
- Run by
- Obstetrix Medical Group
- People needed
- 0
- Starts
- 2005-08-01
- Expected to finish
- 2006-02-01
- Last updated by the study team
- 2014-12-19
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Desert Good Samaritan Hospital — Mesa, Arizona, United States
- Banner Good Sammaritan Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.