CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,058 enrolled
Drug / intervention
Two midwivesbehavioral
Likely dose
Not stated in record
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Search/NCT03770962
NCT03770962N/ACompleted

One Plus One Equals Two - Will That do? A Randomized Controlled Trial to Evaluate Collegial Midwifery Practice to Prevent Perineal Trauma

Region Skane·interventional·Posted Dec 10, 2018·Updated Jul 14, 2021

In Brief

A clinical study evaluating Two midwives for Sphincter (Anal); Perineal Rupture, Obstetric and 4 related conditions. Completed, enrolled 3,058 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 10, 2018
Enrollment StartDec 10, 2018
Primary CompletionMar 21, 2020
Study CompletionJul 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.6 years ago

Interventions

Two midwivesbehavioral

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.