Preterm DeliveryNCT00156000
fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
An observational study of Preterm Delivery and Preterm Birth, run by Obstetrix Medical Group at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Preterm Delivery, Preterm Birth
- What is being tested?
- Fetal Fibronectin and Salivary Estriol
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women (Twins or Triplets) already enrolled in the Obstetrix Clinical Trial " Progesterone for prevention of PTB in twin and triplet pregnancies"
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Desert Good Samaritan Hospital
Mesa, Arizona, 85202
Banner Good Sammaritan Hospital
Phoenix, Arizona, 85006
About this study
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
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.
Read the 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.
- Conditions
- Preterm Delivery, Preterm Birth
- Being tested
- Fetal Fibronectin, Salivary Estriol
- Keywords
- Preterm Delivery, Multifetal pregnancy, Preterm Birth, 17-alpha Hydroxyprogesterone Caproate, Markers of Preterm Birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal FibronectinDevice
Also called fFN
fFN test done during pregnancy
Salivary EstriolDevice
Also called SalEst
Salivary Estriol done during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: This study was stopped because of insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adeza Biomedical
- Responsible party
- Sponsor
- Investigators
- Kimberly Maurel, RN, MSN, CNS, Study director, Obstetrix Medical Group, Inc.Richard Lee, Principal investigator, Obstetrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156000
- Sponsor's protocol ID
- OBX0048.2
- Status last verified
- Dec 2014
- First submitted
- 8 Sep 2005
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/0029-7844(96)00035-x.
PubMed 8677060Darne 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.
PubMed 3101838
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00156000
- Acronym / sponsor ID
- OBX0048.2
- Conditions
- Preterm Delivery, Preterm Birth
- Keywords
- Preterm Delivery, Multifetal pregnancy, Preterm Birth, 17-alpha Hydroxyprogesterone Caproate, Markers of Preterm Birth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was stopped because of insufficient enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Collaborators
- Adeza Biomedical
- Study start
- Aug 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women (Twins or Triplets) already enrolled in the Obstetrix Clinical Trial " Progesterone for prevention of PTB in twin and triplet pregnancies"
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Symptomatic uterine contractions at time of enrollment
- Placenta previa
- Abruptio placenta
- Severe preeclampsia
- Digital examination within 24 hours prior to the fFN sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal FibronectinAlso: fFNfFN test done during pregnancy | Device | – |
| Salivary EstriolAlso: SalEstSalivary Estriol done during pregnancy | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- Background: PubMed 8677060Goldenberg 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.
- Background: PubMed 3101838Darne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Maurel, RN, MSN, CNS study director
Obstetrix Medical Group, Inc.
Richard Lee principal investigator
Obstetrix Medical Group, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Delivery and Preterm Birth, run by Obstetrix Medical Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.