Trial Outcomes & Findings for Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation? (NCT NCT02339389)

Results Overview

If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

Ventilation parameters measured at 2 hour and 4 hour

Results posted on

2018-03-19

Participant Flow

Following approval by our Institutional Review Board, written consent was obtained from 57 healthy, full-term women undergoing elective induction of labor who expressed interest in receiving epidural analgesia.

Participant milestones

Participant milestones
Measure	Study Group Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
Overall Study STARTED	57
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=57 Participants We are simply measuring ventilation changes that occur following labor analgesia. Labor analgesia: Measuring maternal ventilation after placement of epidural analgesia compared to baseline
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	57 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	57 participants n=99 Participants

PRIMARY outcome

Timeframe: Ventilation parameters measured at 2 hour and 4 hour

If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval

Outcome measures

Outcome measures
Measure	Study Group n=41 Participants Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
Changes in Maternal Ventilation During Labor Analgesia Maternal ventilation at baseline	15.3 L/min Standard Deviation 1
Changes in Maternal Ventilation During Labor Analgesia Maternal ventilation at 2 hours	12.6 L/min Standard Deviation 1.1
Changes in Maternal Ventilation During Labor Analgesia Maternal Ventilation at 4 hor	13.8 L/min Standard Deviation 1.2

SECONDARY outcome

Timeframe: 4 hours

If maternal temperature increases during labor analgesia

Outcome measures

Outcome measures
Measure	Study Group n=41 Participants Maternal ventilation was measured non-invasively using the ExSpiron Respiratory Volume Monitor (RVM) in forty-one term parturients who received labor epidural analgesia. Minute ventilation (MV), respiratory rate (RR), and tidal volume (TV) were measured via chest pads using bio-impedance technology. In addition, we recorded vital signs and maternal oral temperature at 5, 10, 15, 20, 25, 30 and 60 min after epidural analgesia initiation, and then every hour until delivery.
If Maternal Temperature Increases During Labor Analgesia baseline temperature	98.1 Degree F Standard Deviation 0.4
If Maternal Temperature Increases During Labor Analgesia Temperature at 4 hour	98.7 Degree F Standard Deviation 0.5

Adverse Events

Ventilation During Labor Analgesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bhavani Kodali

Brigham and Women's Hospital

Phone: 6175258449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place