NCT02625454

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

December 1, 2015

Last Update Submit

July 16, 2019

Conditions

FeverOxidative Stress

Keywords

AcetaminophenLaborIntrapartum FeverMaternal FeverFetal TachycardiaIntravenous Acetaminophen

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (18)

  • 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

  • Mode of Delivery (cesarean section vs vaginal delivery)

    Measured at point of delivery

  • Number of Cesarean Deliveries for Persistent Fetal Tachycardia

    Measured at the point of delivery

  • Number of Patients with Diagnosis of Clinical Chorioamnionitis

    Measured from admission to 7 days post-partum

  • Number of Patients with Diagnosis of Histological Chorioamnionitis

    Measured from placenta histology collected at delivery

  • +13 more secondary outcomes

Study Arms (2)

Intravenous Acetaminophen

EXPERIMENTAL

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

Oral Acetaminophen

ACTIVE COMPARATOR

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

Interventions

Intravenous AcetaminophenDRUG

1000 mg Acetaminophen q 6 hours, given intravenously

Also known as: OFIRMEV
Intravenous Acetaminophen
Oral AcetaminophenDRUG

1000 mg Acetaminophen q 6 hours given orally

Also known as: Tylenol
Oral Acetaminophen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Related Publications (1)

  • Mehraban S, Nematian S, Mehraban SS, Petrucci S, Tricorico G, Parnas Z, Shats L, Kanninen T, Moretti M, Cabbad M, Lakhi N. Randomized control trial of intravenous acetaminophen for reduction of intrapartum maternal fever. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100287. doi: 10.1016/j.ajogmf.2020.100287. Epub 2020 Dec 9.

    PMID: 33451627DERIVED

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nisha Lakhi, MD

    Richmond University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OBGYN Director of Research

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 9, 2015

Study Start

December 1, 2016

Primary Completion

May 1, 2019

Study Completion

October 1, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations

US(1)