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Elective Induction of Nulliparous Labor

NCT01076062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-02-11

No results posted yet for this study

Summary

Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks gestation, on cesarean delivery rates in nulliparous women compared to expectant management (EM).

Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum tests avoided with IOL, to compare the differences in utilization of inpatient resources (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously validated measurements. We will evaluate differences in the rate of cervical change once active labor is diagnosed, and the time from completion of active labor, defined as complete dilation and complete effacement, to the delivery of fetus (definition of second stage of active labor). Furthermore, other secondary outcomes to be evaluated include comparisons between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value of cervical length and Bishop score for vaginal delivery will also be examined.

Conditions

  • Pregnancy

Interventions

PROCEDURE

Induction of Labor

If cervical foley bulb placement is possible, the foley bulb will remain in place until either spontaneously removed or after 12 hrs, whichever is earlier. If placement is not possible, cervical ripening with misoprostol 25 micrograms (mcg) per vagina every 4 hrs (max of 4 total doses) will be initiated. Cervical examination will occur every 4 hr. Repeat doses of misoprostol will be given only if foley bulb placement is not possible and/or if palpably firm uterine contractions are less than 6 in 10 min in consecutive 10 min intervals. Once placement of a cervical foley bulb can be performed, oxytocin administration will begin at 2 mIU/min and increasing by 2 mIU/min every 20 min to ensure adequate contractions (maximum oxytocin infusion rate 36 mIU/min). Adequate contractions will be defined as 7 contractions in 15 min in consecutive 15 min intervals that palpate moderate to firm. Oxytocin infusion will begin not earlier than 4 hrs after the last misoprostol dose (if given).

Sponsors & Collaborators

  • Madigan Army Medical Center

    lead FED

Principal Investigators

  • Nathaniel R Miller, MD · Madigan Army Medical Center

  • Peter Nielsen, MD · Madigan Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-27
Primary Completion
2017-04-24
Completion
2017-04-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076062 on ClinicalTrials.gov