PregnancyNSAILNCT07588529
Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers?
A study testing Electric breast pump for nipple stimulation and induction of labor in people with Pregnancy and Induction of Labor, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Induction of Labor
- What is being tested?
- Electric breast pump for nipple stimulation and induction of labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66103
Rachel Diteresi, MD, 913-588-6200, rditeresi@kumc.edu
Brian Brost, MD, 913-588-6259, bbrost@kumc.edu
About this study
Official title: Nipple Stimulation Acceptability for Induction of Labor
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.
Read the 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.
- Conditions
- Pregnancy, Induction of Labor
- Being tested
- Electric breast pump for nipple stimulation, induction of labor
- Keywords
- nipple stimulation, breast stimulation, induction, labor, induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric breast pump for nipple stimulationOther
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.
induction of laborOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: induction of labor |
| 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. Receives: Other: Electric breast pump for nipple stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Duration of Labor
The investigators will measure the time between induction of labor initiation and delivery of the baby.
Measured: From beginning of induction of labor to delivery of the baby (for each patient).
Secondary outcomes (7)
Average amount of Pitocin used
Average Pitocin per patient used in the different study arms (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
Measured: From beginning of induction of labor to delivery of the baby (for each patient).
Average maximum concentration of Pitocin
The investigators will measure the average maximum concentration of Pitocin needed for each study arm (nulliparous control, nulliparous experimental, multiparous control, multiparous experimental).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From before patient participation to after all patients (48 total) have participated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel DiTeresi, University of Kansas Medical Center
- Investigators
- Brian Brost, MD, Study chair, Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of MedicineRachel DiTeresi, MD, Principal investigator, Clerkship Director for Obstetrics and Gynecology Department at KUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588529
- Sponsor's protocol ID
- STUDY00161207
- Acronym
- NSAIL
- Status last verified
- May 2026
- First submitted
- 17 Dec 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chayen B, Tejani N, Verma U. Induction of labor with an electric breast pump. J Reprod Med. 1986 Feb;31(2):116-8.
PubMed 3959016Stark 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.
PubMed 35042047Adewole 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.
PubMed 7839936
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nipple Stimulation Acceptability for Induction of Labor
- ClinicalTrials.gov ID
- NCT07588529
- Acronym / sponsor ID
- NSAIL / STUDY00161207
- Conditions
- Pregnancy, Induction of Labor
- Keywords
- nipple stimulation, breast stimulation, induction, labor, induction of labor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: induction of laborPatients 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. |
| Nipple Stimulation | Experimental | Other: Electric breast pump for nipple stimulationPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- Maternal
- Inability to give informed consent
- History of cesarean delivery or uterine myomectomy
- History of uterine rupture
- Intrahepatic cholestasis of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric breast pump for nipple stimulationSymphony 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. | Other | Nipple Stimulation |
| induction of laborPatients 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). | Other | Control |
Primary outcome
Total Duration of Labor
Time frame: 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.
7 secondary outcomes
Average amount of Pitocin used
Time frame: From beginning of induction of labor to delivery of the baby (for each patient).
Average maximum concentration of Pitocin
Time frame: From beginning of induction of labor to delivery of the baby (for each patient).
Delivery method
Time frame: Time taken for delivery of newborn
Maternal adverse events
Time frame: From beginning of induction of labor to patient being discharged in postpartum period.
NICU admission
Time frame: From delivery of newborn to discharge from hospital.
APGAR score
Time frame: In the minutes directly after delivery
Acceptability of nipple stimulation as an induction of labor method
Time frame: From before patient participation to after all patients (48 total) have participated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 3959016Chayen B, Tejani N, Verma U. Induction of labor with an electric breast pump. J Reprod Med. 1986 Feb;31(2):116-8.
- Background: PubMed 35042047Stark 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.
- Background: PubMed 7839936Adewole 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Brost, MD study chair
Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine
Rachel DiTeresi, MD principal investigator
Clerkship Director for Obstetrics and Gynecology Department at KUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric breast pump for nipple stimulation and induction of labor in people with Pregnancy and Induction of Labor, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bethany Snyder (9135233650, bsnyder3@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Duration of Labor (time frame: From beginning of induction of labor to delivery of the baby (for each patient).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07588529, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.