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Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)

Primary Purpose

Labor, Induced, Cervix Uteri-Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient Dilapan-S
Inpatient Dilapan-S
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor, Induced focused on measuring Cervical ripening, Labor induction, Outpatient, Mechanical, Hygroscopic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Pregnant woman whose plan of care is induction of labor
  2. Maternal age between 18 and 45 years
  3. Understanding and capable to sign informed consent
  4. Singleton pregnancy
  5. Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
  6. Live fetus in cephalic presentation
  7. Intact membranes
  8. Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced

Exclusion Criteria:

  1. Active labor
  2. Active genital herpes
  3. Chorioamnionitis
  4. Transfundal uterine or cervical surgery
  5. Previous cesarean delivery
  6. Non-reassuring fetal status
  7. Need for continuous maternal or fetal monitoring during ripening
  8. Contraindication for vaginal delivery
  9. Active vaginal bleeding
  10. Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
  11. Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
  12. Intrauterine growth restriction (estimated fetal weight <10 percentile)
  13. Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
  14. Fetal anomaly
  15. Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
  16. Poor or no access to a telephone and cannot be placed in the hotel
  17. Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)

Sites / Locations

  • Columbia University Irving Medical Center
  • UTMB Galveston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient Dilapan-S

Inpatient Dilapan-S

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Number of Participants With Hospital Stay Longer Than 48 Hours
Rate of hospital stay longer than 48 hours (from admission to discharge)

Secondary Outcome Measures

Number of Participants With Vaginal Deliveries 2-4 Days
Rate of vaginal deliveries (%)
Number of Participants With Vaginal Deliveries - 24 Hours
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
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)
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.
Number of Participants With Operative Vaginal Delivery
Rate of operative vaginal deliveries (%)
Number of Participants With Cesarean Delivery
Rate of caesarean deliveries (%)

Full Information

First Posted
August 30, 2018
Last Updated
July 6, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Medicem International CR s.r.o.
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1. Study Identification

Unique Protocol Identification Number
NCT03665688
Brief Title
Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
Acronym
HOMECARE
Official Title
Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Medicem International CR s.r.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Induced, Cervix Uteri-Diseases
Keywords
Cervical ripening, Labor induction, Outpatient, Mechanical, Hygroscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Dilapan-S
Arm Type
Experimental
Arm Description
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
Arm Title
Inpatient Dilapan-S
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Outpatient Dilapan-S
Other Intervention Name(s)
Outpatient cervical ripening with Dilapan-S
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inpatient Dilapan-S
Other Intervention Name(s)
Inpatient cervical ripening with Dilapan-S
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Hospital Stay Longer Than 48 Hours
Description
Rate of hospital stay longer than 48 hours (from admission to discharge)
Time Frame
72 hours or discharge home time, whichever occurs first
Secondary Outcome Measure Information:
Title
Number of Participants With Vaginal Deliveries 2-4 Days
Description
Rate of vaginal deliveries (%)
Time Frame
2-4 days
Title
Number of Participants With Vaginal Deliveries - 24 Hours
Description
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Time Frame
24 hours
Title
Time From Hospital Admission to Active Stage of Labor
Description
Time from hospital admission to reach active stage of labor defined as cervical dilation of ≥ 6 cm (in minutes)
Time Frame
1-2 days
Title
Change in Bishop Score From Insertion of Device to Extraction
Description
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.
Time Frame
12 hours
Title
Number of Participants With Operative Vaginal Delivery
Description
Rate of operative vaginal deliveries (%)
Time Frame
1-4 days
Title
Number of Participants With Cesarean Delivery
Description
Rate of caesarean deliveries (%)
Time Frame
1-4 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Saad, MD
Organizational Affiliation
The University of Texas Medical Branch, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UTMB Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

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Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

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