Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT00957593Other id2-20080907

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 252 participants (actual)
Sponsor: Lehigh Valley Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2009
Primary completion: Aug 2011
Completion: Aug 2011
First posted: 12 Aug 2009 (estimated)
Last update posted: 23 Apr 2019
Conditions: Labor Induction · Cesarean Delivery

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2009201020112012

N/A
Induction of Labor With Oxytocin: When Should Oxytocin be Held?
NCT00957593
Feb 2009 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug
Oxytocin discontinuationDrug

Arms2

Active comparator
Oxytocin
Continuation of oxytocin per protocol once the patient reaches active labor
Active comparator
Oxytocin discontinuation
Oxytocin will be stopped once the patient reaches active labor

Primary outcomes1

Outcomes the sponsor listed as primary.

Cesarean Delivery
Time frame · 24-72 hours from admission for induction
Registry description
Mode of delivery is the primary outcome

Secondary outcomes(1)

Perinatal Outcomes
Time frame · 24-72 hours
Registry description
Perinatal outcomes for patients included in the randomized trial

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24-72 hours from admission for induction

Cesarean Delivery

Group	Value (Cesarean deliveries)
Oxytocin	32
Oxytocin Discontinuation	24

Secondary and other outcome results(1)

Secondary outcomeCount of participants· 24-72 hours

Perinatal Outcomes

Group	Value (Participants)
Routine	70
Discontinuation	66

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin Armno adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM	–	0 / 127	0 / 127
Oxytocin DiscontinuationOxytocin discontinuation in the active phase of labor	–	0 / 125	0 / 125

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2012

Oxytocin discontinuation during active labor in women who undergo labor induction.

Diven et al. 2012American journal of obstetrics and gynecologycited by 19

PMID 22989707DOI 10.1016/j.ajog.2012.08.035PUB-22989707

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Candidates for the study are pregnant women (with one fetus) scheduled for induction of labor with oxytocin at term gestation or greater, regardless of the indication for induction, bishop score (cervical dilation) or parity. Exclusion Criteria: * Exclusions include women with multiple gestations, previous cesarean sections, and documented fetal anomalies. * Women with contraindications to labor or induction will also be excluded.

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