1. A Research-Based Protocol: Blind Vaginal Fetal Fibronectin Collection Stacey Tribbett, RNC, MSN Student

2. Fetal Fibronectin Collection The Stetler Model was used for this protocol. o Phase II: Introduction o Phase II: Validation o Phase III: Comparative Evaluation/Decision Making o Phase IV: Translation/Application o Phase V: Evaluation

3. Phase I: Introduction o Over the last 20 years, the rate of preterm birth (PTB) has increased in every state. In addition, the rate of premature infants who survive (often with severe handicaps) has increased (Goldenberg et al., 2001, p. 1500). o Research topic – The efficacy of “blind” vaginal collection of fetal fibronectin. Fetal fibronectin, a protein detected in vaginal secretions, is a biophysiological marker that indicates increased risk for preterm labor.

4. Phase I: Introduction (continued) o Purpose of this evidence-based protocol is for RN’s to be able to perform the vaginal fetal fibronectin [fFN] test without MD/CNM supervision. The current specimen is obtained by the MD/CNM performing a speculum exam. o Goal is to increase number of fFN tests and increase timeliness of results and treatment of preterm labor.

5. Phase II: Validation o Research has shown that the collection of blind vaginal fFN is as accurate as the collection via speculum collection. o A study was completed comparing vaginal vs. speculum collection. 161 out of 169 were in agreement with one another.

6. Phase II: Validation o The table below shows a study completed by Roman et al. (2004). They collected a total of 1,396 fetal fibronectin tests using the blind vaginal method and concluded that blind vaginal fFN sampling has a high negative predictive values and specificities in predicting preterm birth.

7. Phase II: Validation SensitivitySpecificity Positive Predictive Value Negative Predictive Value Relative Risk P value Delivery </equal to 14 d. 13/25(52)1295/137 1(94.5) 13/89(14. 6) 1295/130 7(99.1) 16.0 (7.5- 34.1) <.001 Delivery </equal to 21 d 20/44(45. 5) 1283/135 2 (94.9) 20/89 (22.5) 1283/130 7 (98.2) 12.3 (7.1- 21.3) <.001 Delivery <34 wk 17/38 (44.7) 334/378 (88.4) 17/61 (27.9) 334/355 (94.1) 4.6 (2.6- 8.2) <.001 Roman et al. (2004) “Blind” Fetal Fibronectin Sampling.

8. Phase III: Comparative Evaluation/Decision Making o Research supports different collection technique that what is currently done in our setting. o Current practice has a time delay for collecting fFN tests due to speculum exam. o Supported by new physician currently collecting by “blind” vaginal technique. o Key players in decision making: RN’s, Obstetricians and Certified Nurse Midwives. o Will need approval from OB department for proceeding with protocol.

9. Phase IV: Translation/Application o Protocols were developed using supportive research for implementing the use of the “blind” vaginal fetal fibronectin test. o A competency was developed for RN’s for collection of fFN. o Adeza representative provided protocols, policy and procedures used by other hospitals, and these were used to develop the competency and protocol as well as the research.

10. Phase IV: Translation/Application o Application process will include: Gaining approval from physicians to change process from speculum examination collection of fFN to blind vaginal collection. Acceptance from RN’s to follow the protocol. Training of RN’s.

11. Phase V: Evaluation o Collection of data from lab to establish if there is an increase in the number of fFN tests collected. o Chart reviews on patients presenting between 22 and 34 weeks with symptoms to establish whether testing was done. o Collection of data on length of stay for patients between 22 and 34 weeks when fFN test completed.

12. Protocol for Fetal Fibronectin Collection Patient 22-34 weeks presents with: Contractions with or without pain Menstrual-like cramping, dull backache and/or pelvic pressure Vaginal spotting Contraindications for fFN test Prior vaginal exam Dilated 3cm or greater Ruptured membranes Post 35 weeks Mod. or heavy bleeding Previa Intercourse past 24 hours. Notify MD/CNM Obtain order for vaginal collection of fFN if no contraindications RN to perform blind Vaginal fFN Notify MD/CNM of positive or negative results