ARRIVE Induction in Pregnant Women Study (PRO00001813)
Description
For those patients who choose to be in the study, when they are within 1 to 2 weeks of their due date, they will be randomized to one of two groups. One group will be assigned to have their baby started through the use of medicine (also called “induction of labor”) within a few days of reaching 39 weeks of pregnancy. Depending on how open their cervix is their doctor will decide the best way to start their labor. Those assigned to the other group will continue with the pregnancy until they either begin labor or their care provider determines that they need to be delivered or they reach 41-42 weeks of gestation (1-2 weeks after the due date). No matter which group the participant is assigned, the care provider will check their cervix during a pelvic examination. For those who are given medicine to start their labor, their baby’s heart rate will be monitored the entire time they are receiving the medication and when they are in labor. After delivery, the research staff will review the participants’ medical charts for clinical and outcome information (for example, treatments or medicines given during labor, whether it was a vaginal delivery or cesarean, etc.). They will also review the chart of the baby. Participants will be asked 2 questions about the pain they experienced during childbirth and will be asked to complete a questionnaire shortly after the baby is born.
Eligibility
- Must not have had a previous pregnancy beyond 20 weeks
- Gestational age at randomization must be between 38 weeks 0 days and 38 weeks 6 days
- Must be a singleton gestation (twin gestation reduce to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
- Must not have ruptured membranes
- Must not plan for cesarean delivery
- Must not be participating in another interventional study that influences the management of labor at delivery