At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
In Brief
A clinical study evaluating Outpatient Dilapan-S and Inpatient Dilapan-S for Labor, Induced and Cervix Uteri-Diseases. Completed, enrolled 338 participants across 2 sites.
Detailed Summary
The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.
Study Details
Timeline
Interventions
After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L\&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L\&D unit for standard protocol of labor induction.
After Dilapan-S placement, subjects will be admitted to L\&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.