Perineal Massage Using A Pelvic Wand During Pregnancy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth.
The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant
Plan to give birth at BIDMC
Age ≥18 years old
English language preference
Disqualifiers
Contraindication to vaginal birth, active genital herpes infection, fetal anomaly requiring cesarean birth).
Trial design
Design model
Parallel
Treatments tested in this trial
Pelvic wand
DeviceUse of a pelvic wand to perform perineal massage
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean score difference between the two arms on the Labor Agentry Scale
A clinically significant difference is defined as a mean score difference of 10 points
Time frame
During hospitalization (assessed up to 5 days)Secondary outcomes
1
The average number of completed massage sessions prior to hospitalization
The average number of completed massage sessions measured by analyzing diary responses between enrollment and admission to the hospital for birth
Time frame
6-8 weeks prior to birth event2
The average number of completed massage sessions during hospitalization
The average number of completed massage sessions measured by analyzing diary responses during birth hospitalization.
Time frame
24-48 hours3
The average number of completed massage sessions postpartum
The average number of completed massage sessions measured by analyzing diary responses in the postpartum period
Time frame
6 weeks post birth time point4
Number of patients with postpartum urinary symptoms
Number of patients with postpartum urinary symptoms based on survey responses.
Time frame
12 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov