Induction of Labor, Pregnancy
Conditions
Keywords
nipple stimulation, breast stimulation, induction, labor, induction of labor
Brief summary
In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps are used to start breast milk production and collect breast milk in patients after delivering their baby. The device uses cup-shaped pieces called flanges that are placed over the patient's nipples and then a gentle vacuum or suction is applied. The mechanical effect of the suction on the nipple is thought to cause the release of a substance called oxytocin in one's body, which encourages labor and contractions to begin. Some reasons why nipple stimulation might be better than other induction of labor methods are that it allows the patient to have more control over their induction process, it uses the patient's own oxytocin instead of synthetic (or factory-produced) oxytocin, and it may shorten the time that it takes to deliver the baby.
Detailed description
Patients will be randomly assigned (like rolling the dice) to one of 2 groups. * Group 1 will follow the standard induction of labor protocol at KUMC. In other words, their induction process will not look any different than if they were not a participant in this study. Their induction process may include, but is not limited to, medications and/or devices to make the body more ready to deliver the baby, medications to increase the uterus muscle contractions, medications to decrease the pain associated with labor, etc. Group 1 will not use nipple stimulation at all as part of their labor. * Group 2 will follow the standard induction of labor protocol with the addition of nipple stimulation using the Symphony PLUS® breast pump for a 2-hour time period. At the time in their labor when the medical team would normally deem them appropriate to initiate synthetic oxytocin (Pitocin), nipple stimulation will be started instead. The breast pump will be placed over one nipple at a time and put on its default vacuum settings. Every 15 minutes, the patient will switch to stimulating the alternate nipple with no breaks of time in between. Depending on how fast the contractions are, the research team may increase or decrease the strength of the breast pump. This will continue for 2 hours, after which they will stop doing nipple stimulation. They will then resume normal induction of labor care as deemed appropriate by the nurses and doctors. Patients will have a 1 in 2 chance (50%) of being randomized to either Group 1 or Group 2. Group assignments will be chosen by a randomization tool. Patients and the study team will be aware of which treatment they are under. After delivering the baby, both groups will take a survey about their induction experience while they are in the hospital. After the survey is collected, patients have completed participation in this study. Patients will continue to receive standard care with their primary physician team. The investigators will take information about the patients and their medical care from the electronic medical record for research purposes. The investigators will be analyzing things such as how long it took from the beginning of induction to the delivery of the baby, if there were any unexpected events, how much synthetic oxytocin was used, and other information about the induction and the health of the baby. The investigators will also analyze the results of the surveys completed.
Interventions
OTHERElectric breast pump for nipple stimulation
Symphony PLUS® breast pump. What distinguishes this induction of labor nipple stimulation study is how we will be applying the nipple stimulation. Many other studies exist, but they apply the stimulation in an uneven or inconsistent manner. They often do not specify how they interpret active and latent labor. Our study will be using nipple stimulation only for 2 hours per experimental participant so that we can better quantify the effect that nipple stimulation has on the labor process.
OTHERinduction of labor
Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin).
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot randomized controlled trial comparing induction of labor with Pitocin (control) against the standard protocol with the addition of nipple stimulation (experimental). Surveys to evaluate patient experience, nursing acceptability, and provider acceptability. Nulliparous (has never delivered before) and multiparous (has delivered at least one child previously) patients will each be randomized into experimental and control sections. 48 patients total to be enrolled, with 24 in each group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
All patients presenting to KUMC labor \& delivery for IOL will be considered for this study. Maternal * ≥18 years old and ≤ 50 years old * ≥37wga and ≤ 42wga * Intact amniotic membranes * English speaking Fetal * Cephalic presentation
Exclusion criteria
Maternal * Inability to give informed consent * History of cesarean delivery or uterine myomectomy * History of uterine rupture * Intrahepatic cholestasis of pregnancy * Maternal life-threatening conditions * Active HSV * Gestational hypertension, Preeclampsia (severe or w/o severe features), HELLP, chronic hypertension on medications Placental * Placenta previa, vasa previa * Suspicion for abnormally adherent placenta * Chorioamnionitis * Placental abruption Fetal * Multifetal gestation * category 2 or 3 fetal heart tracing upon presentation (does not include isolated variable deceleration) * EFW \> 5000 grams in mother with diabetes * EFW \> 4500 grams in mother without diabetes * Fetal demise * Fetal growth restriction \<10th centile * Any other contraindication for vaginal birth or anticipation of need for NICU for care of baby
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Labor | From beginning of induction of labor to delivery of the baby (for each patient). | The investigators will measure the time between induction of labor initiation and delivery of the baby. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average maximum concentration of Pitocin | From beginning of induction of labor to delivery of the baby (for each patient). | The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| Delivery method | Time taken for delivery of newborn | Delivery method (C-section, spontaneous vaginal, or operative vaginal) by percentage needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| Maternal adverse events | From beginning of induction of labor to patient being discharged in postpartum period. | Adverse events (uterine tachysystole, postpartum hemorrhage, any other adverse event) by percentage that occur in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| Average amount of Pitocin used | From beginning of induction of labor to delivery of the baby (for each patient). | Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| APGAR score | In the minutes directly after delivery | Average APGAR score of newborns in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| Acceptability of nipple stimulation as an induction of labor method | From before patient participation to after all patients (48 total) have participated. | Surveys will be administered to patients in their postpartum period, labor and delivery nurses after the patient portion of the study has been completed, and OBGYN providers Pre and Post patient portion of the study. These surveys will ask about familiarity with nipple stimulation, how they liked using it, and if they would use it again for induction of labor. |
| NICU admission | From delivery of newborn to discharge from hospital. | Percentage of newborns requiring NICU admission per study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
Countries
United States
Contacts
CONTACTBethany Snyder
CONTACTRachel DiTeresi, MD
STUDY_CHAIRBrian Brost, MD
Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine
PRINCIPAL_INVESTIGATORRachel DiTeresi, MD
Clerkship Director for Obstetrics and Gynecology Department at KUMC
Outcome results
None listed