Induction of Labor Affected Fetus / Newborn
Conditions
Keywords
cervical ripening, induction of labor
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.
Interventions
DEVICEDilapan S
Placement of Dilapan S
Sponsors
Albany Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to delivery | from induction start to delivery, estimated average 12 hours | Length of time between induction of labor start and delivery (hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with maternal infection | during hospital admission, average 4 days | chorioamnionitis, endometritis - Yes/No |
| NICU admission | through maternal hospital admission, average 4 days | Neonatal admission to NICU (any admission) - Yes/No |
| APGAR score at 1and 5 min | 1 and 5 minutes after birth | APGAR score (number 0-10) |
| Need for resipiratory support | during hospital admission, average 4 days | any respiratory interventions after birth for neonate (composite of oxygen administration, respiratory distress syndrome, CPAP, intubation) (yes/No) |
| mode of delivery | one time at the time of delivery, variable to occur during hospital admission, average 4 days | cesarean or vaginal (coded as cesarean delivery Y/N or vaginal delivery Y/N) |
| Need for neonatal antibiotics | in the first 72 hours after delivery | any antibiotic use in postnatal period (yes/no) |
Countries
United States
Outcome results
None listed