Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?
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ClinicalTrials.gov Identifier: NCT00371046 |
Recruitment Status :
Completed
First Posted : September 1, 2006
Last Update Posted : March 2, 2007
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The objective of this study is to investigate the effect of the use of both sonographic cervical length (CL) and fetal fibronectin (FFN) on the length of outpatient triage and preterm labor interventions in symptomatic women with intact membranes.
We performed a randomized trial of the use of transvaginal ultrasound cervical length and fetal fibronectin in women being evaluated for suspected PTL at a gestational age between 24 and 33 weeks 6 days. Women are randomized to either a standard (blinded) or a protocol arm. Women in the standard arm are evaluated without the results of the CL and FFN while women in the protocol arm are evaluated using the results of the CL and FFN and managing physicians are asked to follow a specific PTL algorithm to determine a women’s eligibility for treatment. The primary outcome is length of stay in the triage area before discharge.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Birth | Procedure: Transvaginal ultrasound cervical length Procedure: Cervicovaginal fetal fibronectin | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | The Use of Fetal Fibronectin and Transvaginal Ultrasound Cervical Length in Women With Threatened Preterm Labor:A Randomized Trial |
Study Start Date : | October 2003 |
Study Completion Date : | December 2006 |
- Length of time for evaluation for preterm labor
- Admission for preterm labor
- Preterm delivery less than 37 weeks
- Preterm delivery less than 34 weeks

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- gestational age between 24 and 33 weeks 6 days
- contractions ≥ 6/hr, uterine irritability, or symptoms such as cramping, pressure, backache with or without documented contractions which prompted evaluation for PTL
- cervical dilatation < 3cm and < 100% effacement
- intact membranes.
Exclusion criteria:
- ruptured membranes
- known congenital anomaly
- triplets or greater;
- vaginal bleeding
- cervical dilatation ≥ 3cm or complete effacement;
- cerclage
- known short cervix Women transferred on tocolytics were also excluded

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371046
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Amen Ness, MD | Thomas Jefferson University | |
Study Director: | Vincenzo Berghella, MD | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00371046 History of Changes |
Other Study ID Numbers: |
O4U.289 |
First Posted: | September 1, 2006 Key Record Dates |
Last Update Posted: | March 2, 2007 |
Last Verified: | March 2007 |
Keywords provided by Thomas Jefferson University:
preterm labor transvaginal ultrasound cervical length fetal fibronectin preterm birth |
Additional relevant MeSH terms:
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |