Clinical trial NCT03665688: Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
Official title: Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Induced
Cervix Uteri-Diseases
Keywords: Cervical ripening
Labor induction
Outpatient
Mechanical
Hygroscopic
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Medicem International CR s.r.o.
First posted: 2018-09-11
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants With Hospital Stay Longer Than 48 Hours
timeFrame: 72 hours or discharge home time, whichever occurs first
Secondary outcomes:
measure: Number of Participants With Vaginal Deliveries 2-4 Days
timeFrame: 2-4 days
measure: Number of Participants With Vaginal Deliveries - 24 Hours
timeFrame: 24 hours
measure: Time From Hospital Admission to Active Stage of Labor
timeFrame: 1-2 days
measure: Change in Bishop Score From Insertion of Device to Extraction
timeFrame: 12 hours
measure: Number of Participants With Operative Vaginal Delivery
timeFrame: 1-4 days
measure: Number of Participants With Cesarean Delivery
timeFrame: 1-4 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Galveston
country: United States
facility: UTMB Galveston
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch, Galveston
name: Antonio Saad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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