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Induction of Labor (IOL) arm for Pregnancy

N/A
Waitlist Available
Led By Nathaniel R Miller, MD
Research Sponsored by Madigan Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 39 weeks gestation
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~39 weeks gestation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 39 weeks gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cesarean Birth Rate

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Induction of Labor (IOL) armExperimental Treatment1 Intervention
Elective induction of labor at 39 weeks.
Group II: Expectant management (EM) armActive Control1 Intervention
Standard of care: routine clinic appointments until they deliver, fetal heart rate and contraction monitoring during their 41st week if not delivered. Also if they have not gone into labor the subjects will be scheduled for an induction by 42 weeks.

Find a Location

Who is running the clinical trial?

Madigan Army Medical CenterLead Sponsor
48 Previous Clinical Trials
18,004 Total Patients Enrolled
Peter Nielsen, MDStudy DirectorMadigan Army Medical Center
Nathaniel R Miller, MDPrincipal InvestigatorMadigan Army Medical Center

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~13 spots leftby May 2025