An interventional study of Outpatient Dilapan-S and Inpatient Dilapan-S in Labor, Induced and Cervix Uteri-Diseases, sponsored by The University of Texas Medical Branch, Galveston. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
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.
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.
The University of Texas Medical Branch, Galveston is the lead sponsor of 256 studies on the registry; 39 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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 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.
Also known as: Outpatient cervical ripening with 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.
Also known as: Inpatient cervical ripening with Dilapan-S
Number of Participants With Hospital Stay Longer Than 48 Hours
Rate of hospital stay longer than 48 hours (from admission to discharge)
Time frame: 72 hours or discharge home time, whichever occurs first
Number of Participants With Vaginal Deliveries 2-4 Days
Rate of vaginal deliveries (%)
Time frame: 2-4 days
Number of Participants With Vaginal Deliveries - 24 Hours
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Time frame: 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)
Time frame: 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.
Time frame: 12 hours
Number of Participants With Operative Vaginal Delivery
Rate of operative vaginal deliveries (%)
Time frame: 1-4 days
Number of Participants With Cesarean Delivery
Rate of caesarean deliveries (%)
Time frame: 1-4 days
| Milestone | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Started | 167 | 171 |
| Completed | 167 | 171 |
| Not completed | 0 | 0 |
Rate of hospital stay longer than 48 hours (from admission to discharge)
| Participants | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Number of Participants With Hospital Stay Longer Than 48 Hours | 89 | 152 |
Rate of vaginal deliveries (%)
| Participants | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Number of Participants With Vaginal Deliveries 2-4 Days | 125 | 128 |
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
| Participants | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Number of Participants With Vaginal Deliveries - 24 Hours | 117 | 86 |
Time from hospital admission to reach active stage of labor defined as cervical dilation of ≥ 6 cm (in minutes)
| minutes | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Time From Hospital Admission to Active Stage of Labor | 545 (492 to 690) | 1183 (1141 to 1265) |
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.
| score on a scale | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Change in Bishop Score From Insertion of Device to Extraction | 2 (1 to 4) | 2 (1 to 4) |
Rate of operative vaginal deliveries (%)
| Participants | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Number of Participants With Operative Vaginal Delivery | 6 | 5 |
Rate of caesarean deliveries (%)
| Participants | Outpatient Dilapan-S | Inpatient Dilapan-S |
|---|---|---|
| Number of Participants With Cesarean Delivery | 42 | 43 |
Collected over at the time the participant are enrolled into the study, up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Outpatient Dilapan-S | 0/167 (0%) | 0/167 (0%) | 0/167 (0%) |
| Inpatient Dilapan-S | 0/171 (0%) | 0/171 (0%) | 0/171 (0%) |
| Age, Continuous(years) | Outpatient Dilapan-S | Inpatient Dilapan-S | Total |
|---|---|---|---|
| Mean | 25.2 ± 5.6 | 25.9 ± 5.6 | 25.5 ± 5.6 |
| Sex: Female, Male(Participants) | Outpatient Dilapan-S | Inpatient Dilapan-S | Total |
|---|---|---|---|
| Female | 167 | 171 | 338 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Outpatient Dilapan-S | Inpatient Dilapan-S | Total |
|---|---|---|---|
| Hispanic or Latino | 120 | 112 | 232 |
| Not Hispanic or Latino | 47 | 59 | 106 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Outpatient Dilapan-S | Inpatient Dilapan-S | Total |
|---|---|---|---|
| United States | 167 | 171 | 338 |
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2018 to primary completion in Nov 2021, 35 months.
Results were first posted in Jul 2023, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Medical Branch, Galveston →