Effects of Digital Vaginal Examination During Labor on Pain and Anxiety Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-03-31

Brief Summary

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Digital vaginal examination is the most common method for assessing progress of labor and delivery. Considering it is the most common intervention women receive during course of labor, evidence for psychological effects of digital vaginal examination on women is surprisingly sparse. Reducing the number of vaginal examination during labor has been proposed by many authors as benefit of more vaginal examination is unclear. However this is unlikely to happen until more research on the topic demonstrates clear detrimental effects of vaginal examination.

Our study is aimed at investigating association of vaginal examination with psychological distress of women during labor. Anxiety during labor is associated with longer labor duration, increased perception of pain, problems with newborn attachment, and increased rates of postpartum depression and post-traumatic stress disorder. In this study, women were assigned to either digital vaginal examination or transperineal ultrasound assessment groups were compared to each other in a randomised controlled setting.

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Detailed Description

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Conditions

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Pregnancy Obstetric Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital vaginal examination

Patients assigned to this group will be followed-up with digital vaginal examinations as described in intervention protocol.

Group Type ACTIVE_COMPARATOR

Digital vaginal examination

Intervention Type OTHER

Patients will be subject to digital vaginal examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

Transperineal ultrasound examination

Patients assigned to this group will be followed-up with transperineal ultrasound examinations as described in intervention protocol.

Group Type EXPERIMENTAL

Transperineal ultrasound examination

Intervention Type DEVICE

Patients will be subject to transperineal ultrasound examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

Interventions

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Digital vaginal examination

Patients will be subject to digital vaginal examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

Intervention Type OTHER

Transperineal ultrasound examination

Patients will be subject to transperineal ultrasound examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Multiparous women
* Spontaneous active labor
* Cephalic presentation

Exclusion Criteria

* Women with known psychiatric disorders
* Labor induction
* Advanced labor during admission (Dilatation greater than 7cm)
* Presence of a prenatally diagnosed anomaly in fetus
* Admission to neonatal intensive care unit after delivery
* Delayed hospital discharge due to excessive weight loss of neonate

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes