An interventional study of Dilapan S in Induction of Labor Affected Fetus / Newborn, sponsored by Albany Medical College. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Albany Medical College · Not applicable, Interventional, and Other
This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies >=39 weeks.
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.
Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placement of dilators
Device: Dilapan S
Placement of Dilapan S
Time to delivery
Length of time between induction of labor start and delivery (hours)
Time frame: from induction start to delivery, estimated average 12 hours
APGAR score at 1and 5 min
APGAR score (number 0-10)
Time frame: 1 and 5 minutes after birth
number of participants with maternal infection
chorioamnionitis, endometritis - Yes/No
Time frame: during hospital admission, average 4 days
NICU admission
Neonatal admission to NICU (any admission) - Yes/No
Time frame: through maternal hospital admission, average 4 days
Need for neonatal antibiotics
any antibiotic use in postnatal period (yes/no)
Time frame: in the first 72 hours after delivery
Need for resipiratory support
any respiratory interventions after birth for neonate (composite of oxygen administration, respiratory distress syndrome, CPAP, intubation) (yes/No)
Time frame: during hospital admission, average 4 days
mode of delivery
cesarean or vaginal (coded as cesarean delivery Y/N or vaginal delivery Y/N)
Time frame: one time at the time of delivery, variable to occur during hospital admission, average 4 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Albany Medical College