Induction of Labor
Conditions
Brief summary
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
Detailed description
Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later. We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.
Interventions
DEVICETrans-cervical cervical balloon
Insertion of Foley Catheter
DEVICEHygroscopic cervical dilator
Insertion of Dilapan-s
Sponsors
Northwell Health
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).
Exclusion criteria
* 1\. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (\< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc. * 2\. Simplified Bishop score must be \<6 and cervical dilation \<2 cm. * 3\. Women must be able to give informed consent. * 4\. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive. * 5\. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from start of cervical ripening to delivery | 720-2160 minutes | Time in minutes from placement of cervical ripening agent to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain of insertion | First hour | Patient assessment of pain on insertion using pain analog scale |
| Pain over duration of cervical ripening | 12-14 hours | Patient assessment of pain on admission using pain analog scale |
| Patient satisfaction with cervical ripening agent | 24-36 hours | Patient survey postpartum day #1 regarding cervical ripening experience |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of shoulder dystocia | 12-36 hours | Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients |
| Incidence of intra-amniotic infection | 12-36 hours | Number of patients diagnosed with intra-amniotic infection (maternal temperature \>38C, maternal (\>120) or fetal (\>160) tachycardia) divided by number of all enrolled patients |
| Incidence of post-partum hemorrhage | 12-36 hours | Number of patients diagnosed with post-partu hemorrhage (QBL \>1000 ml) divided by number of all enrolled patients |
| 10 minute Apgar score <7 | 12-36 hours | Number of infants with 10 minute Apgar score \<7 divided by number of all enrolled patients |
| Rate of device expulsion prior to admission | 12-14 hours | Number of patients reporting expulsion of the device prior to planned admission |
| Umbilical cord gas pH <7 | 12-36 hours | Number of infants with umbilical cord gas \<7 divided by number of all enrolled patients |
| Composite score of adverse neonatal outcomes | 12-72 hours | Composite of perinatal adverse outcomes (the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support) |
| Composite score of serious maternal morbidity or mortality | 12-72 hours | Composite score of serious maternal morbidity (e.g. uterine rupture, admission to intensive care unit, septicemia), or death. |
| Base excess >12 | 12-36 hours | Number of infants with base excess \>12 divided by number of all enrolled patients |
| Rate of onset of labor prior to planned admission | 12-14 hours | Number of patients presenting in active labor prior to planned admission divided by all enrolled patients |
| Rate of cesarean delivery | 12-36 hours | Number of patients requiring cesarean delivery divided by number of all enrolled patients |
| Rate of operative vaginal delivery | 12-36 hours | Number of patients requiring operative vaginal delivery divided by number of all enrolled patients |
Countries
United States
Outcome results
None listed