Clinical trial NCT04521062: Dilapan-S® for Induction of Labor The Feasibility Study
Official title: Dilapan-S® for Induction of Labor - Assessing ouTpatient Placement and Effectiveness - The Feasibility Study (The DILATE Study).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: cervical ripening
induction of labor
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies \>=39 weeks.

Detailed description: In 2019, the ARRIVE trial was published, demonstrating that in low risk nulliparous women, induction of labor at 39 weeks was associated with a decreased risk for hypertensive disorders of pregnancy and decreased risk for cesarean without any increased risk for severe neonatal complications or perinatal death. (1) Based on the results of this trial, hospitals have been questioning the feasibility of implementing a protocol which offers induction of labor to low risk women at ≥39 weeks. There are concerns regarding the ability of a busy labor and delivery to accommodate women presenting for inductions with an unfavorable cervix. Outpatient mechanical cervical ripening would allow for women to start the process of induction of labor at home. This is appealing because cervical ripening is typically the longest component of the induction process. Mechanical cervical ripening is the process by which balloons or dilators are placed into the cervix.

There is lack of evidence on Dilapan-S® as an outpatient method of cervical ripening despite the potential benefits of increased maternal satisfaction and decreased length of hospital stay. With this in mind we propose a preliminary study of 40 women to assess for feasibility of performing a large randomized control trial and assess safety with outpatient treatment. This initial study is intended to assess the feasibility of outpatient cervical ripening, next day induction of labor, and safety. After completion of this feasibility study, the investigators plan to initiate a randomized control trial to assess the efficacy of outpatient Dilapan-S® for mechanical cervical ripening.

Eligibility criteria: Inclusion Criteria:

1. Planned induction of labor ≥ 39 weeks
2. Singleton gestation
3. Vertex presentation
4. Cervical dilation \<3cm

Exclusion Criteria:

1. Placenta previa
2. Placenta accreta
3. Vasa previa
4. Preterm prelabor rupture of membranes
5. Non-english speaking
6. \<18 years old
7. Multiple gestation
8. Prior cesarean delivery
9. Prior myomectomy
10. Fetal malpresentation
11. Active vaginal bleeding
12. Cervical dilation \>1 cm
13. Uterine anomaly (didelphysis, bicornuate)
14. Intrauterine growth restriction \<10th%
15. Fetal anomalies
16. Requirements to be inpatient
17. Polyhydramnios (AFI\>25cm or MVP\>8cm)
18. Chronic hypertension on medications
19. Gestational hypertension/preeclampsia
20. GDMA2, DM1, DM2
21. Hepatitis B or C
22. HIV

Primary outcomes:
measure: Time to delivery
timeFrame: from induction start to delivery, estimated average 12 hours
Secondary outcomes:
measure: APGAR score at 1and 5 min
timeFrame: 1 and 5 minutes after birth
measure: number of participants with maternal infection
timeFrame: during hospital admission, average 4 days
measure: NICU admission
timeFrame: through maternal hospital admission, average 4 days
measure: Need for neonatal antibiotics
timeFrame: in the first 72 hours after delivery
measure: Need for resipiratory support
timeFrame: during hospital admission, average 4 days
measure: mode of delivery
timeFrame: one time at the time of delivery, variable to occur during hospital admission, average 4 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Tara Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References: