Reduction of Intrapartum Fever With Intravenous Acetaminophen

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الدخول التسجيل فى الموقع

يتم حفظ الارتباط في الحافظة

الحالةنشيط ، لا يجند

الرعاة

Richmond University Medical Center

تجربة سريرية: NCT02625454

BioSeek: NCT02625454

الكلمات الدالة

نبذة مختصرة

The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in laboring patients by either an oral or intravenous (IV) route. The investigators want to see if the maternal fever will decrease faster with the IV or the oral dose. The investigators also want to look at other outcomes such as the cesarean section rate, the rate of neonatal intensive care unit admissions in both groups.

وصف

This is a randomized, controlled, study of intravenous (IV) acetaminophen (OFIRMEV) versus orally administrated acetaminophen for the reduction of intrapartum maternal fever and fetal tachycardia. Compared to oral acetaminophen, intravenous acetaminophen has increased bioavailability and more rapid onset of action. IV acetaminophen has been used successfully in the management of fever in post-operative patients. Additionally, intravenous acetaminophen has also been used in the intrapartum setting for management of pain.However, the use of intravenous acetaminophen for the treatment of maternal temperature and subsequent fetal tachycardia, has not yet been evaluated.

The study will have two arms that will be randomized in a 1:1 ratio. A double dummy, double blind, comparator controlled study design will be utilized. After inclusion criteria have been satisfied, subjects in the control arm will receive an oral dose 1000 mg acetaminophen and an intravenous placebo resembling Ofirmev. The subjects in the experimental arm will receive 1000 mg of IV Ofirmev and an oral placebo resembling acetaminophen. Both groups will receive standard obstetrical care, continuous fetal monitoring, and antibiotics if there is suspected chorioamnionitis. The blinding technique will eliminate provider bias.

تواريخ

آخر التحقق:	06/30/2019
تم الإرسال لأول مرة:	11/30/2015
تم إرسال التسجيل المقدر:	12/03/2015
أول نشر:	12/08/2015
تم إرسال آخر تحديث:	07/15/2019
آخر تحديث تم نشره:	07/16/2019
تاريخ بدء الدراسة الفعلي:	11/30/2016
تاريخ الإنجاز الأساسي المقدر:	04/30/2019
التاريخ المتوقع لانتهاء الدراسة:	09/30/2019

حالة أو مرض

Fever

Oxidative Stress

التدخل / العلاج

Drug: Intravenous Acetaminophen

Drug: Oral Acetaminophen

مرحلة

مرحلة 2

مجموعات الذراع

ذراع	التدخل / العلاج
Experimental: Intravenous Acetaminophen Subjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen	Drug: Intravenous Acetaminophen 1000 mg Acetaminophen q 6 hours, given intravenously
Active Comparator: Oral Acetaminophen Subjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen	Drug: Oral Acetaminophen 1000 mg Acetaminophen q 6 hours given orally

معايير الأهلية

الأعمار المؤهلة للدراسة	18 Years إلى 18 Years
الأجناس المؤهلة للدراسة	Female
يقبل المتطوعين الأصحاء	نعم
المعايير	Inclusion Criteria: - Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius. Exclusion Criteria: - Exclusion Criteria: Infants delivered before 36 week gestation, stillbirths, congenital fetal anomalies, scheduled cesarean deliveries, and acetaminophen allergy

النتيجة

مقاييس النتائج الأولية

1. Change in Maternal Body Temperature [01, 15, 30, 60 and 90, 120, 180, 240, 300, 360 minutes following Time 01 (Time 01 = time when first dose of acetaminophen was administered]

مقاييس النتائج الثانوية

1. Change in Fetal Heart Rate [01, 15, 30, 60 and 90, 120, 180, 240, 300, 360 minutes following Time 01 (Time 01 = time when first dose of acetaminophen was administered]

2. Mode of Delivery (cesarean section vs vaginal delivery) [Measured at point of delivery]

3. Number of Cesarean Deliveries for Persistent Fetal Tachycardia [Measured at the point of delivery]

4. Number of Patients with Diagnosis of Clinical Chorioamnionitis [Measured from admission to 7 days post-partum]

5. Number of Patients with Diagnosis of Histological Chorioamnionitis [Measured from placenta histology collected at delivery]

6. Neonatal Apgar Score [One and Five minutes of life]

7. Number of Infants Admitted to Neonatal Intensive Care Unit [First 7 days of life]

8. Number of Infants with Culture Positive Neonatal Sepsis [First 7 days of life]

9. Number of infants requiring additional respiratory intervention [First 24 hours of life]

10. Number of Infants Developing Neonatal Seizures [First 7 days of life]

11. Number of infants with fetal acidosis [Point of Delivery]

12. Maternal Levels of Pro-Inflammatory Mediators [Admission and 4 hours after delivery]

C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

13. Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood [Point of Delivery]

C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

14. Maternal Levels of Oxidative Stress Markers [Admission and 4 hours after delivery]

Thioredoxin Reductase (TrxR), Gluathione (GSH)

15. Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood [point of delivery]

Thioredoxin Reductase (TrxR), Gluathione (GSH)

16. Levels of Acetaminophen in Cord Blood [point of delivery]

17. Maternal Liver Function Test [12-24 hours after delivery]

aspartate aminotransferase (AST), alanine aminotransferase (ALT)

18. Maternal White Blood Count (WBC) [Admission and 12-24 hours after delivery]