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| Name | Class |
|---|---|
| Medicem International CR s.r.o. | INDUSTRY |
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Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley Bulb Group | Active Comparator | Patients will have a Foley catheter inserted into the internal cervical os. |
|
| Dilapan Group | Experimental | Patients will have Dilapan sticks inserted into the internal cervical os. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilapan | Device | Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Vaginal Delivery | Proportion of patients that delivered vaginal. (%) | Through study completion, an average of 1-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Vaginal Delivery | Delivery time frame in mins from cervical dilator insertion | 2-4 days |
| Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins) |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia Requirement | Rate of women who require any analgesia used during insertion of the device | 1-2 days |
| Spontaneous Labor | Rate of women underwent spontaneous labor (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Saad, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas | Galveston | Texas | 77555 | United States | ||
| UTMB Galveston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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From November 2016 to February 2018 at UTMB Galveston
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| ID | Title | Description |
|---|---|---|
| FG000 | Foley Bulb Group | Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. |
| FG001 | Dilapan Group | Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These demographics includes all that were randomized. 2 participants withdrew consent in the dilapan group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Foley Bulb Group | Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Vaginal Delivery | Proportion of patients that delivered vaginal. (%) | Posted | Count of Participants | Participants | Through study completion, an average of 1-2 years |
|
Duration of the trial: up to 2 weeks after discharge from hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foley Bulb Group | Patients will have a Foley catheter inserted into the internal cervical os. Foley Catheter: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin breakdown from mobility due to epidural. Unrelated to the study since device was already removed and epidural placed after the intervention (Foley balloon ) was removed. Occurred in the postpartum period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio F Saad | UTMB | 4097720982 | afsaad@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2016 | Apr 12, 2019 | Prot_SAP_000.pdf |
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|
| Foley Catheter | Device | Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. |
|
|
| 1-2 days |
| Change in Bishop Scores | Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method | 12-24 hrs |
| Operative Deliveries | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. | 1-4 days |
| Cesarean Deliveries | Proportion of patients that delivered by cesarean (%). | 1-4 days |
| 1-4 days |
| Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%) | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) | 1-2 days |
| Artificial Rupture of Membranes (AROM) | Rate of women that had artificial rupture of membranes (AROM) (%) | 1-2 days |
| Regional Anesthesia | Rate of epidural/spinal analgesia (%) | 1-2 days |
| Device Insertion Time | Total duration of Dilapan-S® /Foley catheter insertion (mins) | 1-2 days |
| Device Placement to Delivery Interval | Interval from device placement to delivery (mins) | 1-4 days |
| Time After Mechanical Dilator | Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins) | 1-2 days |
| Comparison of Labor Curves Between Both Interventions | Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon | 1-2 days |
| Device Complications | Rates of complications resulting from device insertion (%): Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia) | 1-2 days |
| Galveston |
| Texas |
| 77555 |
| United States |
| Dilapan Group |
Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Median | Inter-Quartile Range | weeks |
|
| Nulliparous | Count of Participants | Participants |
|
| Bishop score at randomization | The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method | Median | Inter-Quartile Range | scores on a scale |
|
|
|
| Secondary | Time of Vaginal Delivery | Delivery time frame in mins from cervical dilator insertion | Posted | Median | Full Range | minutes | 2-4 days |
|
|
|
| Secondary | Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins) | Posted | Median | Full Range | minutes | 1-2 days |
|
|
|
| Secondary | Change in Bishop Scores | Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method | Posted | Median | Full Range | score on a scale | 12-24 hrs |
|
|
|
| Secondary | Operative Deliveries | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. | Posted | Count of Participants | Participants | 1-4 days |
|
|
|
| Secondary | Cesarean Deliveries | Proportion of patients that delivered by cesarean (%). | Posted | Count of Participants | Participants | 1-4 days |
|
|
|
| Other Pre-specified | Analgesia Requirement | Rate of women who require any analgesia used during insertion of the device | Posted | Count of Participants | Participants | 1-2 days |
|
|
|
| Other Pre-specified | Spontaneous Labor | Rate of women underwent spontaneous labor (%) | Not Posted | 1-4 days | Participants |
| Other Pre-specified | Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%) | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) | Not Posted | 1-2 days | Participants |
| Other Pre-specified | Artificial Rupture of Membranes (AROM) | Rate of women that had artificial rupture of membranes (AROM) (%) | Not Posted | 1-2 days | Participants |
| Other Pre-specified | Regional Anesthesia | Rate of epidural/spinal analgesia (%) | Not Posted | 1-2 days | Participants |
| Other Pre-specified | Device Insertion Time | Total duration of Dilapan-S® /Foley catheter insertion (mins) | Posted | Mean | Standard Deviation | minutes | 1-2 days |
|
|
|
| Other Pre-specified | Device Placement to Delivery Interval | Interval from device placement to delivery (mins) | Posted | Median | Full Range | minutes | 1-4 days |
|
|
|
| Other Pre-specified | Time After Mechanical Dilator | Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins) | Not Posted | 1-2 days | Participants |
| Other Pre-specified | Comparison of Labor Curves Between Both Interventions | Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon | Not Posted | 1-2 days | Participants |
| Other Pre-specified | Device Complications | Rates of complications resulting from device insertion (%): Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia) | Not Posted | 1-2 days | Participants |
| 0 |
| 209 |
| 2 |
| 209 |
| 0 |
| 209 |
| EG001 | Dilapan Group | Patients will have Dilapan sticks inserted into the internal cervical os. Dilapan: Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. | 0 | 208 | 0 | 208 | 0 | 208 |
|
| Motor vehicle collision | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 motor vehicle accident - occurred postpartum within 2 weeks of delivery. Resulted in prolonged hospitalization |
|
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