Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03665688
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Medicem International CR s.r.o.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Labor, Induced Cervix Uteri-Diseases Device: Outpatient Dilapan-S Device: Inpatient Dilapan-S Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : November 7, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: Outpatient Dilapan-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

Device: Outpatient Dilapan-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.
Other Name: Outpatient cervical ripening with Dilapan-S

Active Comparator: Inpatient Dilapan-S
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
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 Name: Inpatient cervical ripening with Dilapan-S




Primary Outcome Measures :
  1. Hospital Stay [ Time Frame: 48hours ]
    Rate of hospital stay longer than 48 hours (from admission to discharge)

  2. Healthcare cost impact [ Time Frame: 2-4 days ]
    Healthcare cost impact will be assessed based on direct hospital costs or Medicaid charges, using cost minimization technique.


Secondary Outcome Measures :
  1. Vaginal deliveries [ Time Frame: 2-4 days ]
    Rate of vaginal deliveries (%)

  2. Vaginal deliveries 24 hrs [ Time Frame: 24 hours ]
    Rate of vaginal deliveries within 24 hours since admission to hospital (%)

  3. Vaginal deliveries 36 hrs [ Time Frame: 36 hours ]
    Rate of vaginal deliveries within 36 hours since admission to hospital (%)

  4. Admission to active labor [ Time Frame: 1-2 days ]
    Time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)

  5. Device to active labor [ Time Frame: 1-3 days ]
    Time from device placement to reach active stage of labor defined as ≥ 6 cm (mins)

  6. Bishop score change [ Time Frame: 12 hours ]
    Change in Bishop score (based on cervical dilation, position of cervix, effacement of cervix, fetal station and softness of cervix) from insertion to extraction of device

  7. Cervical change [ Time Frame: 12 hours ]
    Change in cervical dilation after Dilapan-S

  8. Vaginal delivery after one round of mechanical dilator [ Time Frame: 12 hours ]
    Rate of spontaneous vaginal deliveries after one round of cervical ripening (%) (no additional medical or mechanical interventions)

  9. Operative vaginal delivery [ Time Frame: 1-4 days ]
    Rate of operative vaginal deliveries (%)

  10. Cesarean delivery [ Time Frame: 1-4 days ]
    Rate of caesarean deliveries (%)

  11. AROM [ Time Frame: 1-4 days ]
    Rate of artificial rupture of membranes (AROM) (%)

  12. Epidural [ Time Frame: 1-4 days ]
    Rate of epidural analgesia (%)

  13. Device time [ Time Frame: 12 hours ]
    Total duration of Dilapan-S® application (insertion to removal/extraction) (mins)

  14. Device to delivery time [ Time Frame: 1-4 days ]
    Device placement to delivery interval (mins)

  15. Induction time [ Time Frame: 48 hours ]
    Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665688


Locations
Layout table for location information
United States, Texas
UTMB Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Antonio Saad, MD    409-772-0982    afsaad@utmb.edu   
Contact: Ashley Salazar    140927720312    assalaza@utmb.edu   
Principal Investigator: Antonio Saad, MD         
Sub-Investigator: George Saade, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Medicem International CR s.r.o.
Investigators
Layout table for investigator information
Principal Investigator: Antonio Saad, MD The University of Texas Medical Branch, Galveston

Publications:

Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03665688     History of Changes
Other Study ID Numbers: 18-0132
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The University of Texas Medical Branch, Galveston:
Cervical ripening
Labor induction
Outpatient
Mechanical
Hygroscopic

Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Diseases
Genital Diseases, Female