Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

NCT ID: NCT03665688

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2021-11-05

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.

Conditions

Labor, Induced; Cervix Uteri-Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Outpatient Dilapan-S

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Inpatient Dilapan-S

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Outpatient cervical ripening with Dilapan-S; Inpatient cervical ripening with Dilapan-S

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medicem International CR s.r.o.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Saad, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Locations

Columbia University Irving Medical Center

New York, New York, United States

UTMB Galveston

Galveston, Texas, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-0132

Identifier Type: -

Identifier Source: org_study_id