Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

Study Overview
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Brief Summary
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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
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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.

Official Title
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Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)

Conditions
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Labor, Induced, Cervix Uteri-Diseases

Intervention / Treatment
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* Device: Outpatient Dilapan-S
* Device: Inpatient Dilapan-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman whose plan of care is induction of labor Maternal age between 18 and 45 years Understanding and capable to sign informed consent Singleton pregnancy Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound) Live fetus in cephalic presentation Intact membranes Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced Exclusion Criteria: Active labor Active genital herpes Chorioamnionitis Transfundal uterine or cervical surgery Previous cesarean delivery Non-reassuring fetal status Need for continuous maternal or fetal monitoring during ripening Contraindication for vaginal delivery Active vaginal bleeding Abnormal placental location or adherence (placenta previa or unresolved low lying placenta) Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic) Intrauterine growth restriction (estimated fetal weight <10 percentile) Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm) Fetal anomaly Need for inpatient care (e.g. hypertension, insulin-dependent diabetes) Poor or no access to a telephone and cannot be placed in the hotel Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Dilapan-S<br>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 | Device: Outpatient Dilapan-S<br>* 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.<br>* Other names: Outpatient cervical ripening with Dilapan-S;|
| Active Comparator: Inpatient Dilapan-S<br>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. | Device: Inpatient Dilapan-S<br>* 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.<br>* Other names: Inpatient cervical ripening with Dilapan-S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hospital Stay Longer Than 48 Hours | Rate of hospital stay longer than 48 hours (from admission to discharge) | 72 hours or discharge home time, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vaginal Deliveries 2-4 Days | Rate of vaginal deliveries (%) | 2-4 days | 
| Number of Participants With Vaginal Deliveries - 24 Hours | Rate of vaginal deliveries within 24 hours since admission to hospital (%) | 24 hours | 
| Time From Hospital Admission to Active Stage of Labor | Time from hospital admission to reach active stage of labor defined as cervical dilation of ≥ 6 cm (in minutes) | 1-2 days | 
| Change in Bishop Score From Insertion of Device to Extraction | Change in Bishop score (based on cervical dilation, position of cervix, effacement of cervix, fetal station and softness of cervix) . Calculated as Bishop score value at 12 hours minus value at baseline. Bishop score ranges from zero to 13, with zero meaning you're not ready for induction and 13 indicating a better chance for successful induction. A higher score means that labor is closer, and that induction has a good chance of being successful. | 12 hours | 
| Number of Participants With Operative Vaginal Delivery | Rate of operative vaginal deliveries (%) | 1-4 days | 
| Number of Participants With Cesarean Delivery | Rate of caesarean deliveries (%) | 1-4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical ripening, Labor induction, Outpatient, Mechanical, Hygroscopic