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Induction of Labor With Oxytocin: When Should Oxytocin be Held?

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ClinicalTrials.gov Identifier: NCT00957593
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : May 29, 2013
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Joanne Quinones, MD, Lehigh Valley Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Labor Induction
Cesarean Delivery
Interventions Drug: Oxytocin
Drug: Oxytocin discontinuation
Enrollment 252
Recruitment Details ROUTINE oxytocin 127 Discontinuation of oxytocin 125
Pre-assignment Details  
Arm/Group Title Oxytocin Oxytocin Discontinuation
Hide Arm/Group Description Continuation of oxytocin per protocol once the patient reaches active labor Oxytocin will be stopped once the patient reaches active labor
Period Title: Overall Study
Started 127 125
Completed 127 125
Not Completed 0 0
Arm/Group Title Oxytocin Oxytocin Discontinuation Total
Hide Arm/Group Description Continuation of oxytocin per protocol once the patient reaches active labor Oxytocin will be stopped once the patient reaches active labor Total of all reporting groups
Overall Number of Baseline Participants 127 125 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 125 participants 252 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
127
 100.0%
125
 100.0%
252
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 125 participants 252 participants
27.1  (5.6) 27.7  (5.7) 27.4  (0.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 125 participants 252 participants
Female
127
 100.0%
125
 100.0%
252
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 127 participants 125 participants 252 participants
127 125 252
1.Primary Outcome
Title Cesarean Delivery
Hide Description Mode of delivery is the primary outcome
Time Frame 24-72 hours from admission for induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Oxytocin Discontinuation
Hide Arm/Group Description:
Continuation of oxytocin per protocol once the patient reaches active labor
Oxytocin will be stopped once the patient reaches active labor
Overall Number of Participants Analyzed 127 125
Measure Type: Number
Unit of Measure: Cesarean deliveries
32 24
2.Secondary Outcome
Title Perinatal Outcomes
Hide Description Perinatal outcomes for patients included in the randomized trial
Time Frame 24-72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Routine use of oxytocin vs discontinuation of oxytocin once in active labor 127 ROUTINE 125 discontinuation
Arm/Group Title Routine Discontinuation
Hide Arm/Group Description:
Routine use of oxytocin vs discontinuation of oxytocin once in active labor
Oxytocin discontinued in the active phase of labor
Overall Number of Participants Analyzed 127 125
Measure Type: Count of Participants
Unit of Measure: Participants
Male gender
70
  55.1%
66
  52.8%
Neonatal resuscitation
9
   7.1%
7
   5.6%
Admission to NICU
10
   7.9%
9
   7.2%
Neonatal antibiotic use
9
   7.1%
16
  12.8%
Time Frame Period for which data were collected includes the duration of the study, February 2009 to August 2011.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Arm Oxytocin Discontinuation
Hide Arm/Group Description no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM Oxytocin discontinuation in the active phase of labor
All-Cause Mortality
Oxytocin Arm Oxytocin Discontinuation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Oxytocin Arm Oxytocin Discontinuation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/127 (0.00%)   0/125 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Arm Oxytocin Discontinuation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/127 (0.00%)   0/125 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joanne N. Quinones MD MSCE
Organization: Lehigh Valley Health Netword
Phone: 6104021221
EMail: joanne_n.quinones@lvhn.org
Publications of Results:
Diven LC, Rochon ML, Gogle J, Eid S, Smulian JC, Quinones JN. Oxytocin discontinuation during active labor in women who undergo labor induction. Am J Obstet Gynecol. 2012 Dec;207(6):471.e1-8. doi: 10.1016/j.ajog.2012.08.035. Epub 2012 Sep 7.
Layout table for additonal information
Responsible Party: Joanne Quinones, MD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00957593    
Other Study ID Numbers: 2-20080907
First Submitted: July 31, 2009
First Posted: August 12, 2009
Results First Submitted: October 13, 2012
Results First Posted: May 29, 2013
Last Update Posted: April 23, 2019