Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
Condition: Labor, Induced; Cervix Uteri-Diseases
MeSH terms: Uterine Diseases
Study type: Interventional

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.
    

Detailed description: 
      Group Assigned to Outpatient Cervical Ripening After Dilapan-S® placement, subject will be
      monitored for at least 30 minutes. If no contraindications, such as tachysystole, active
      vaginal bleeding, rupture of membranes or nonreassuring fetal testing (defined as minimal or
      absent variability, abnormal baseline, or presence of decelerations) evidence of labor, or
      other serious medical conditions deemed by the clinical staff or the attending physician to
      preclude outpatient cervical ripening develop after insertion, the subjects will be
      randomized. After randomization subject will record the pain she experienced during insertion
      in the patient's survey (see Appendix 3). Those subjects randomized to outpatient ripening
      will be given the option to either return home or to stay in a hotel if transportation is an
      issue. The cost for the hotel will be covered by the study budget. Subjects will be allowed
      to ambulate, shower and perform regular activity during that period. "Nothing per vagina"
      will be allowed (incl. intercourse, tampons etc.).

      Group Assigned to Inpatient Cervical Ripening Subjects randomized to inpatient management
      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.

      Labor Induction and Labor Management of the subject after the initial 12 hours of
      pre-induction or following the earlier removal or spontaneous expulsion of the dilator will
      be the same for both groups and at the discretion of the clinical team. Additional ripening
      (mechanical or prostaglandins) and/or oxytocin may or may not be needed. If needed, duration,
      type and dose of additional ripening agents and oxytocin will be documented.

      Routine intrapartum care will be provided and relevant data collected by the subject's
      managing obstetrical team.
    

Intervention name(s): Outpatient Dilapan-S; Inpatient Dilapan-S
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): Outpatient cervical ripening with Dilapan-S; Inpatient cervical ripening with Dilapan-S
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical ripening; Labor induction; Outpatient; Mechanical; Hygroscopic