Trial Outcomes & Findings for Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production (NCT NCT00361712)

NCT ID: NCT00361712

Last Updated: 2018-04-09

Results Overview

Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: Right after enrollment
• Results posted on: 2018-04-09

Participant Flow

Women in labor were recruited for the study at entry to the triage area of the delivery room of a major tertiary medical center from January to May 2006.

Participant milestones

Measure	Randomized to Early Epidural Analgesia Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.
Overall Study STARTED	20	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production

Baseline characteristics by cohort

Measure	Randomized to Early Epidural Analgesia n=20 Participants Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request n=21 Participants Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.	Total n=41 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 3.6 • n=5 Participants	29.1 years STANDARD_DEVIATION 4.9 • n=7 Participants	30.5 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Israel	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Right after enrollment

Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment

Outcome measures

Measure	Randomized to Early Epidural Analgesia n=20 Participants Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request n=21 Participants Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment	12.7 pg/ml Standard Deviation 4.5	14.2 pg/ml Standard Deviation 7

PRIMARY outcome

Timeframe: 24 hours after delivery

Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery

Outcome measures

Measure	Randomized to Early Epidural Analgesia n=20 Participants Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request n=21 Participants Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.
Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery	15.22 pg/ml Standard Deviation 5.6	16.77 pg/ml Standard Deviation 0

PRIMARY outcome

Timeframe: At birth of parturients

Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery

Outcome measures

Measure	Randomized to Early Epidural Analgesia n=20 Participants Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request n=21 Participants Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth	1 pg/ml Standard Deviation 0.6	1.5 pg/ml Standard Deviation 1.3

Adverse Events

Randomized to Early Epidural Analgesia

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Randomized to Epidural Analgesia Upon Request

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Randomized to Early Epidural Analgesia n=20 participants at risk Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions	Randomized to Epidural Analgesia Upon Request n=21 participants at risk Parturient's pain was monitored every 15 min until it reached a level of \>50 on the VAS and then epidural analgesia was initiated.
Pregnancy, puerperium and perinatal conditions Hyoptension	20.0% 4/20 • Adverse events were recorded throughout study participation period four months	0.00% 0/21 • Adverse events were recorded throughout study participation period four months
Pregnancy, puerperium and perinatal conditions meconium in the amniotic fluid	25.0% 5/20 • Adverse events were recorded throughout study participation period four months	0.00% 0/21 • Adverse events were recorded throughout study participation period four months

Additional Information

Dr Leonid Edilman

Rabin Medical Center

Phone: 972-9376850

Email: leidelman@clalit.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place