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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.
Patients will be randomly assigned (like rolling the dice) to one of 2 groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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). In other words, their induction will be the same as if they were not enrolled in the study. |
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| Nipple Stimulation | Experimental | Patients randomized to the experimental group will undergo standard IOL protocol with the addition of nipple stimulation. At the time when the labor and delivery team deems a patient suitable for Pitocin initiation, patients will begin using a Symphony PLUS® breast pump for nipple stimulation. The breast pump will be turned on and placed on one breast (around the nipple) for 15 minutes, alternating breasts every 15 minutes. The default pump vacuum settings will be utilized. Contraction pattern and pump settings will be assessed every 30 minutes and adjusted if needed to maintain uterine contractions at a rate between 3 and 5 contractions per 10 minutes averaged over 30 minutes. Patients will perform nipple stimulation for no greater and no less than 2 hours. They will then resume normal care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric breast pump for nipple stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Duration of Labor | The investigators will measure the time between induction of labor initiation and delivery of the baby. | From beginning of induction of labor to delivery of the baby (for each patient). |
| Measure | Description | Time Frame |
|---|---|---|
| Average amount of Pitocin used | Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). | From beginning of induction of labor to delivery of the baby (for each patient). |
| Average maximum concentration of Pitocin |
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Inclusion Criteria:
All patients presenting to KUMC labor & delivery for IOL will be considered for this study.
Maternal
Exclusion Criteria:
Maternal
Placental
Fetal
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bethany Snyder | Contact | 9135233650 | bsnyder3@kumc.edu | |
| Rachel DiTeresi, MD | Contact | 913-588-6200 | rditeresi@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian Brost, MD | Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine | Study Chair |
| Rachel DiTeresi, MD | Clerkship Director for Obstetrics and Gynecology Department at KUMC |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3959016 | Background | Chayen B, Tejani N, Verma U. Induction of labor with an electric breast pump. J Reprod Med. 1986 Feb;31(2):116-8. | |
| 35042047 | Background | Stark EL, Athens ZG, Son M. Intrapartum nipple stimulation therapy for labor induction: a randomized controlled external pilot study of acceptability and feasibility. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100575. doi: 10.1016/j.ajogmf.2022.100575. Epub 2022 Jan 15. |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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|
| induction of labor | Other | 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). |
|
The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). |
| From beginning of induction of labor to delivery of the baby (for each patient). |
| Delivery method | Delivery method (C-section, spontaneous vaginal, or operative vaginal) by percentage needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). | Time taken for delivery of newborn |
| Maternal adverse events | 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). | From beginning of induction of labor to patient being discharged in postpartum period. |
| NICU admission | Percentage of newborns requiring NICU admission per study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). | From delivery of newborn to discharge from hospital. |
| APGAR score | Average APGAR score of newborns in each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental). | In the minutes directly after delivery |
| Acceptability of nipple stimulation as an induction of labor method | 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. | From before patient participation to after all patients (48 total) have participated. |
| 7839936 | Background | Adewole IF, Franklin O, Matiluko AA. Cervical ripening and induction of labour by breast stimulation. Afr J Med Med Sci. 1993 Dec;22(4):81-5. |