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N/A N=252 Randomized Treatment

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

Labor Induction · Cesarean Delivery

Enrolled (actual)
252
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Cesarean Delivery — 32; 24 Cesarean deliveries

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Oxytocin (Drug); Oxytocin discontinuation (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Lehigh Valley Hospital
Primary completion
Aug 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Cesarean Delivery
32; 24
SECONDARY
Perinatal Outcomes
70; 66; 9; 7; 10; 9

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00957593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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