Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®

Not Applicable

Completed

Conditions: Labor, Induced
Cervix Uteri-Diseases

Interventions: Device: Outpatient Dilapan-S
Device: Inpatient Dilapan-S

Registration Number: NCT03665688

Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 338

Inclusion Criteria

Pregnant woman whose plan of care is induction of labor
Maternal age between 18 and 45 years
Understanding and capable to sign informed consent
Singleton pregnancy
Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
Live fetus in cephalic presentation
Intact membranes
Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced

Exclusion Criteria

Active labor
Active genital herpes
Chorioamnionitis
Transfundal uterine or cervical surgery
Previous cesarean delivery
Non-reassuring fetal status
Need for continuous maternal or fetal monitoring during ripening
Contraindication for vaginal delivery
Active vaginal bleeding
Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
Intrauterine growth restriction (estimated fetal weight <10 percentile)
Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
Fetal anomaly
Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
Poor or no access to a telephone and cannot be placed in the hotel
Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Dilapan-S	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
Inpatient Dilapan-S	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants With Cesarean Delivery	1-4 days	Rate of caesarean deliveries (%)
Number of Participants With Vaginal Deliveries - 24 Hours	24 hours	Rate of vaginal deliveries within 24 hours since admission to hospital (%)
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 (%)
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.
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)