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Electric breast pump for Oxytocin

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Yale New Haven Hospital, New Haven, CTOxytocin+3 MoreElectric breast pump - Device
Eligibility
18+
Female
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Study Summary

This trial will compare the effects of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The primary hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery.

Eligible Conditions
  • Physiological Effects of Drugs
  • Oxytocin
  • Labor Pain
  • Induction of Labor

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
intravenous oxytocin
1
Outpatient
1
Tension

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: up to 28 days following delivery

Week 12
Subject-reported breastfeeding success
Subject-reported depression score
6-96 hours after delivery
Subject-reported feelings of control during labor and childbirth
Subject-reported satisfaction during labor and childbirth
Week 12
Mastitis
At 5 minutes after birth
Neonatal Apgar score ≤3 at 5 minutes of life
At delivery
Cesarean delivery
Labor induction duration
Operative vaginal delivery
Spontaneous vaginal delivery
Umbilical acidemia
Hour 2
Subject-reported pain during childbirth
Hour 24
Postpartum hemorrhage
Day 28
Composite neonatal severe morbidity measure
Neonatal Intensive Care Unit admission

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
intravenous oxytocin
1
Outpatient
1
Tension

Trial Design

2 Treatment Groups

Exogenous oxytocin intravenous infusion
1 of 2
Intrapartum nipple stimulation
1 of 2

Active Control

Experimental Treatment

562 Total Participants · 2 Treatment Groups

Primary Treatment: Electric breast pump · No Placebo Group · Phase 4

Intrapartum nipple stimulation
Device
Experimental Group · 1 Intervention: Electric breast pump · Intervention Types: Device
Exogenous oxytocin intravenous infusion
Drug
ActiveComparator Group · 1 Intervention: Exogenous oxytocin intravenous infusion · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days following delivery

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,711 Previous Clinical Trials
20,477,465 Total Patients Enrolled
Moeun Son, MD, MSCIPrincipal InvestigatorYale University, Yale School of Medicine
1 Previous Clinical Trials
1,003 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have never given birth to a child.
You are pregnant with only one baby.
References

Frequently Asked Questions

Has the Electric breast pump met all safety criteria established by the FDA?

"Our team estimates the safety of electric breast pumps to be a 3, as Phase 4 trials denote that this method has already been approved." - Anonymous Online Contributor

Unverified Answer

Is enrollment in the trial still accepting participants?

"As per clinicaltrials.gov, this trial is still accepting patients for participation. It was first advertised on November 15th 2021 and more recently updated on January 24th 2022." - Anonymous Online Contributor

Unverified Answer

In what instances does a healthcare provider commonly recommend an electric breast pump?

"Electric breast pumps can assist with managing hemorrhaging, childbirth, and uterine contraction." - Anonymous Online Contributor

Unverified Answer

How many subjects are enrolled in this trial?

"Affirmative. According to the clinicaltrials.gov website, this research trial is open for recruitment and began on November 15th 2021 before being updated most recently on January 24th 2022. It requires 562 participants from a single medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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