Stimulation Therapy for Inducing Mothers

NCT04756089 | Completed

• 1 other identifier: 2000029909
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot feasibility and acceptability study of a randomized clinical trial of pregnant women at 36 weeks of gestation and greater randomized to one of two arms at Yale New Haven Hospital: (1) Breast stimulation by hand or with an electronic breast pump (intervention) compared to (2) Exogenous oxytocin intravenous infusion (current standard of care, control). The pilot study will be randomized since one of the goals is to evaluate whether the idea of randomization would be acceptable to patients.

Conditions

Induced; Birth; Labor Long; Labor Pain; Breast Pumping; Lactation Induced

Outcome Measures

Primary Outcomes (3)

• Recruitment (enrollment) rate

  Determine the rate of eligible women who consent and enroll in the study among eligible women who are approached by research study staff.

  3 months

• Adherence rate

  Determine the rate of randomized women who remain in the trial and complete all study procedures as outlined in the protocol among all women who are consented and randomized to study intervention.

  3 months

• Cross-over frequencies

  Determine the percentage of women in each study intervention arm who cross over to the other study arm (i.e. cross-over from breast stimulation to exogenous intravenous oxytocin infusion in less than 2 hours, or cross-over from exogenous intravenous oxytocin infusion to breast stimulation) prior to their delivery

  3 months

Study Arms (2)

Breast stimulation

EXPERIMENTAL

Participants randomized to the breast stimulation will use breast stimulation by hand or with an electronic breast pump (intervention) to stimulate labor.

Device: Electronic breast pump

Exogenous oxytocin intravenous infusion

ACTIVE COMPARATOR

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to stimulate labor.

Other: Exogenous oxytocin intravenous infusion

Interventions

Electronic breast pump DEVICE

Participants randomized to the breast stimulation will use breast stimulation by hand or with an electronic breast pump (intervention) to stimulate labor.

Also known as: Medela Symphony pump

Breast stimulation

Exogenous oxytocin intravenous infusion OTHER

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to stimulate labor.

Exogenous oxytocin intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Age 18 years and older
• Gestational age 36 weeks and greater at randomization
• Vertex-presenting singleton gestation, or presenting gestation (a.k.a. Fetus A) is vertex-presenting in a multiple gestation
• Undergoing induction of labor
• Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider
• Absence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before randomization

You may not qualify if:

• Unable to understand English
• Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, uncontrolled HIV infection, previous transmural myomectomy)
• Fetal demise
• Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
• Suspected fetal growth restriction (EFW \<10th percentile)
• Suspected alloimmunization
• Unexplained active vaginal bleeding
• History of mastectomy, breast lumpectomy, or contraindication to use of electronic breast pump
• Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution
• Impairment of upper extremity motor function (e.g., quadriplegia)
• Significantly impaired consciousness or executive function (e.g., intubated or sedated)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 35042047 DERIVED

MeSH Terms

Conditions

Labor Pain; Breast Milk Expression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot feasibility and acceptability study of a randomized clinical trial of pregnant women at 36 weeks of gestation and greater randomized to one of two arms at Yale New Haven Hospital: (1) breast stimulation by hand or with a breast pump versus (2) exogenous intravenous oxytocin infusion (standard of care, control). The pilot study will be randomized since one of the goals is to evaluate whether the idea of randomization would be acceptable to patients.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: March 13, 2021
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)