Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04756089 |
| Other study ID # |
2000029909 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2021 |
| Est. completion date |
June 23, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Almost four million women give birth each year in the United States with more than 27% of
them undergoing induction of labor. Generally, labor induction is indicated when the benefits
of expeditious delivery outweigh the risks of continuing the pregnancy. Additionally, labor
induction is increasingly seen as a potentially therapeutic intervention even in the absence
of any pregnancy complication for nulliparas after 39 weeks of gestation. However, induction
of labor is usually associated with a longer latent phase compared to spontaneous labor, and
may result in the need for cesarean delivery at an individual level when an induction attempt
fails. Furthermore, it has been shown that women who are induced are less likely to be
satisfied with their birth experience compared to those with spontaneous labor. Women are
increasingly interested in a less medicalized birth experience and desire more control during
their labor process. Lastly, the cost and infrastructure that would be required to
universally apply routine induction of labor at 39 weeks of gestation are frequently cited as
prohibitive, despite its associated improved outcomes.
Breast stimulation has been purported as a natural and inexpensive non-medical method for
inducing labor that may give patients greater control over the process and have other
potential clinical benefits. It is thought that breast stimulation induces uterine
contractility by increasing the level of endogenous oxytocin hormone. Breast stimulation was
historically used successfully for inducing contractions for the purposes of contraction
stress testing.
A Cochrane review was performed in 2010 that compared breast stimulation with either no
intervention or oxytocin infusion for labor induction. They found a significant reduction in
the number of women not in labor at 72 hours (62.7% vs. 93.6%, RR 0.67, 95% CI 0.60-0.74) and
the incidence of postpartum hemorrhage (0.7% vs. 6%, RR 0.16, 95% CI 0.03-0.87) among those
who underwent breast stimulation compared to those who did not receive any intervention for
induction. There were no benefits seen when comparing women who underwent breast stimulation
versus those who received oxytocin alone. Despite the promising findings, the Cochrane Review
raised the possibility of safety concerns due to one trial that reported four perinatal
deaths (three in the breast stimulation group and one in the oxytocin group). However, that
study was conducted in India, women were not monitored during breast stimulation, there was
no clearly reported method of randomization, and there were very few study details divulged.
The Cochrane Review ultimately had limited conclusions for several reasons. First, most
included studies compared breast stimulation to no intervention, which is not the appropriate
alternative when it has been determined that a labor induction is indicated. Additionally,
most studies involved breast stimulation by hand at home for 1-3 hours per day and included
only women with "low-risk" or un-specified risk pregnancies.
Only one previous trial has tested breast stimulation by breast pump, which showed that the
time to reach the active phase of labor was significantly reduced among women who underwent
breast stimulation compared to those who received oxytocin in the hospital setting. There was
no difference in the length of labor between groups once women were considered to be in the
active phase of labor or mode of delivery, but the trial included just 62 women.
Reassuringly, only one of the 30 women assigned to breast stimulation requested
discontinuation due to nipple soreness after 5.5 hours of intermittent stimulation.
Breast stimulation by hand or with an electronic breast pump is a biologically plausible
method of labor induction that can potentially allow labor induction to be more efficient and
may also have other benefits. These may include effects related to improved uterine
contractility (e.g., successful labor induction and decreased postpartum hemorrhage risk),
patient satisfaction with the induction process, and the stimulation of endogenous oxytocin
which may improve postpartum breastfeeding and positive emotional responses. A well-designed
randomized clinical trial is needed to evaluate the efficacy and safety of breast
stimulation, particularly in comparison to the clinical alternative (use of exogenous
oxytocin).
This is a proposed prospective parallel group randomized controlled external pilot study of
breast stimulation by hand or with an electronic breast pump compared to exogenous oxytocin
infusion to assess acceptability and feasibility prior to conducting a large non-inferiority
randomized trial.
The two arms in this study are: (1) Breast stimulation by hand or with an electronic breast
pump (intervention) compared to (2) Exogenous oxytocin intravenous infusion (current standard
of care, control).
