Skip to main content
Clinical Trials/NCT02599610
NCT02599610
Unknown
Not Applicable

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

Ankara University1 site in 1 country40 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Ankara University
Enrollment
40
Locations
1
Primary Endpoint
Anxiety levels
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erkan Kalafat

Research Assistant

Ankara University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Anxiety levels

Time Frame: Between 12 to 48 hours

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.

Labor pain

Time Frame: Between 12 to 48 hours

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.

Study Sites (1)

Loading locations...

Similar Trials