Cervix Uteri-Diseases, Labor, Induced
Conditions
Keywords
Cervical ripening, Labor induction, Outpatient, Mechanical, Hygroscopic
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.
Interventions
DEVICEOutpatient 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.
DEVICEInpatient 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.
Sponsors
Medicem International CR s.r.o.
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Stay Longer Than 48 Hours | 72 hours or discharge home time, whichever occurs first | Rate of hospital stay longer than 48 hours (from admission to discharge) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaginal Deliveries - 24 Hours | 24 hours | Rate of vaginal deliveries within 24 hours since admission to hospital (%) |
| Time From Hospital Admission to Active Stage of Labor | 1-2 days | Time from hospital admission to reach active stage of labor defined as cervical dilation of ≥ 6 cm (in minutes) |
| Number of Participants With Vaginal Deliveries 2-4 Days | 2-4 days | Rate of vaginal deliveries (%) |
| Number of Participants With Operative Vaginal Delivery | 1-4 days | Rate of operative vaginal deliveries (%) |
| Number of Participants With Cesarean Delivery | 1-4 days | Rate of caesarean deliveries (%) |
| Change in Bishop Score From Insertion of Device to Extraction | 12 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 167 |
| 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.
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. | 171 |
| Total | 338 |
Baseline characteristics
| Characteristic | Outpatient Dilapan-S | Inpatient Dilapan-S | Total |
|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 5.6 | 25.9 years STANDARD_DEVIATION 5.6 | 25.5 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 120 Participants | 112 Participants | 232 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 59 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 167 participants | 171 participants | 338 participants |
| Sex: Female, Male Female | 167 Participants | 171 Participants | 338 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 171 |
| other Total, other adverse events | 0 / 167 | 0 / 171 |
| serious Total, serious adverse events | 0 / 167 | 0 / 171 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient Dilapan-S | Number of Participants With Hospital Stay Longer Than 48 Hours | 89 Participants |
| Inpatient Dilapan-S | Number of Participants With Hospital Stay Longer Than 48 Hours | 152 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Outpatient Dilapan-S | Change in Bishop Score From Insertion of Device to Extraction | 2 score on a scale |
| Inpatient Dilapan-S | Change in Bishop Score From Insertion of Device to Extraction | 2 score on a scale |
Secondary
Number of Participants With Cesarean Delivery
Rate of caesarean deliveries (%)
Time frame: 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient Dilapan-S | Number of Participants With Cesarean Delivery | 42 Participants |
| Inpatient Dilapan-S | Number of Participants With Cesarean Delivery | 43 Participants |
Secondary
Number of Participants With Operative Vaginal Delivery
Rate of operative vaginal deliveries (%)
Time frame: 1-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient Dilapan-S | Number of Participants With Operative Vaginal Delivery | 6 Participants |
| Inpatient Dilapan-S | Number of Participants With Operative Vaginal Delivery | 5 Participants |
Secondary
Number of Participants With Vaginal Deliveries 2-4 Days
Rate of vaginal deliveries (%)
Time frame: 2-4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient Dilapan-S | Number of Participants With Vaginal Deliveries 2-4 Days | 125 Participants |
| Inpatient Dilapan-S | Number of Participants With Vaginal Deliveries 2-4 Days | 128 Participants |
Secondary
Number of Participants With Vaginal Deliveries - 24 Hours
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient Dilapan-S | Number of Participants With Vaginal Deliveries - 24 Hours | 117 Participants |
| Inpatient Dilapan-S | Number of Participants With Vaginal Deliveries - 24 Hours | 86 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Outpatient Dilapan-S | Time From Hospital Admission to Active Stage of Labor | 545 minutes |
| Inpatient Dilapan-S | Time From Hospital Admission to Active Stage of Labor | 1183 minutes |