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One Plus One Equals Two, Will That do?

NCT03770962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3058

Last updated 2021-07-14

No results posted yet for this study

Summary

A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby. The midwife responsible for the birth is the primary carer of the woman and the second midwife observes the birth or assists the primary midwife if asked to. The hypothesis is that the presence and support of an extra midwife will reduce severe perineal trauma (trauma to the anal sphincter (OASI)).

The objective of this trial is to evaluate whether collegial midwifery assistance during the second stage reduces perineal trauma grade III-IV.

Conditions

  • Sphincter (Anal); Perineal Rupture, Obstetric
  • Perineal Tear
  • Pelvic Floor Disorders
  • Experience, Life
  • Second Stage of Labor

Interventions

BEHAVIORAL

Two midwives

Two midwives will be present during the active phase of the second stage and the birth of the baby. "Midwife no 1" is the midwife who has been responsible for the care of the woman and "midwife no 2" will assist her.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Christine Rubertsson, Professor · Institution of Health Sciences, The Faculty of Medicine, Lund University

  • Pia Teleman, Ass.prof · Region Skåne SUS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2020-03-21
Completion
2021-07-13

Countries

  • Sweden

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 NCT03770962 on ClinicalTrials.gov