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 : May 29, 2013
The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol.
One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and then maintained at the same level throughout labor. The second arm will follow an oxytocin protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine hyperstimulation, maternal and neonatal outcomes.
As mentioned in the study proposal, the proposed experimental arm is currently not performed as part of the oxytocin guidelines at the investigators' institution. One study from Israel suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some providers stop the oxytocin in active labor for their patients, this is not a commonly performed procedure at the investigators' institution. The investigators are not aware of other institutions employing the above practice.
|Condition or disease||Intervention/treatment||Phase|
|Labor Induction Cesarean Delivery||Drug: Oxytocin Drug: Oxytocin discontinuation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction of Labor With Oxytocin: When Should Oxytocin be Held?|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Active Comparator: Oxytocin
Continuation of oxytocin per protocol once the patient reaches active labor
Continuation of oxytocin once in active labor
Active Comparator: Oxytocin discontinuation
Oxytocin will be stopped once the patient reaches active labor
Drug: Oxytocin discontinuation
Oxytocin will be stopped once in active labor
- Cesarean Delivery [ Time Frame: 24-72 hours from admission for induction ]Mode of delivery is the primary outcome
- Perinatal Outcomes [ Time Frame: 24-72 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957593
|United States, Pennsylvania|
|Lehigh Valley Health Network|
|Allentown, Pennsylvania, United States, 18105|
|Principal Investigator:||Joanne N Quinones, MD MSCE||Lehigh Valley Health Network|