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

Study Overview
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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.

Official Title
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Effects of Digital Vaginal Examination During Labor on Pain and Anxiety : a Randomised Controlled Trial

Conditions
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Pregnancy, Obstetric Labor

Intervention / Treatment
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* Other: Digital vaginal examination
* Device: Transperineal ultrasound examination


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digital vaginal examination<br>Patients assigned to this group will be followed-up with digital vaginal examinations as described in intervention protocol. | Other: Digital vaginal examination<br>* 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.<br>|
| Experimental: Transperineal ultrasound examination<br>Patients assigned to this group will be followed-up with transperineal ultrasound examinations as described in intervention protocol. | Device: Transperineal ultrasound examination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety levels | Anxiety levels of the patients will be assessed with the State-Trait Anxiety Inventory (STAI) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery. | Between 12 to 48 hours | 
| Labor pain | Perceived pain level of the patients will be assessed with Visual Analog Scale (VAS) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery. | Between 12 to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor, vaginal examination, transperineal ultrasound, pain, anxiety