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

NCT02599610 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-02-17

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Obstetric Labor

Interventions

OTHER

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.

DEVICE

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.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Erkan Kalafat, MD · Ankara University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599610 on ClinicalTrials.gov