One Plus One Equals Two, Will That do?
Condition: Sphincter (Anal); Perineal Rupture, Obstetric; Perineal Tear; Pelvic Floor Disorders; Experience, Life; Second Stage of Labor
MeSH terms: Pelvic Floor Disorders; Rupture
Study type: Interventional

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.
    

Detailed description: 
      Most women sustain some form of perineal trauma when giving birth vaginally. Perineal
      injuries are classified as grade I-IV. A first-degree tear only includes perineal skin or
      mucosa, whereas a second-degree tear includes muscles in the perineal body. A tear involving
      a part or the whole of the anal sphincter muscle complex is graded III-IV. Data from the
      Swedish National Birth Register show that 4% of first-time mothers suffered a tear affecting
      the anal sphincter. National registers in Sweden only collect data on severe perineal trauma
      affecting the anal sphincter but in a recent regional Swedish study 78% of the primiparous
      women experienced second-degree tears. The consequences of second-degree tears and severe
      perineal trauma are pain, dyspareunia, and an increased risk of symptomatic pelvic organ
      prolapse later in life. A severe consequence of perineal trauma is anal incontinence, mainly
      caused by tears affecting the anal sphincter muscle. However, second-degree tears may also
      lead to anal incontinence. This may be related to a lack of support from the perineal body
      due to poor repair. Furthermore, perineal trauma is known to be misclassified, with
      consequent under-reporting of injuries affecting the anal sphincter complex.

      Risk factors for severe perineal trauma (grade III-IV) are giving birth vaginally for the
      first time, having an assisted vaginal birth, giving birth vaginally after a previous
      caesarean section, or giving birth to a baby that weighs more than 4000 g, and the risk
      increases with age. Some of the midwifery care methods used to prevent perineal injuries have
      been evaluated in clinical trials but there are still gaps in the investigator's knowledge.
      Even if scientific evidence is lacking for most of the preventive strategies used by midwives
      except for warm compresses held at the perineum, midwives believe that a slow and controlled
      birth is a key factor in prevention. Several studies indicate that a combination of
      strategies can be effective in preventing perineal trauma. Giving birth is a profound
      experience for the woman and her partner and an experience that has significance for the
      woman all her life. The second stage is considered to be the most stressful part of the labor
      for the woman and her unborn baby, and consequently also for the midwife. Despite this, there
      is still a lack of knowledge about how women experience the second stage and the methods
      midwives use to facilitate birth and prevent perineal trauma. Traditionally midwives have
      asked colleagues for a second opinion or to assist in complicated situations, or in obstetric
      emergencies. Recently a new clinical practice has been introduced in approximately 50% of the
      maternity wards in Sweden to reduce severe perineal trauma. This procedure involves two
      midwives attending the woman during the second stage of labor. The midwife responsible for
      the birth calls for the second midwife when the active phase of the second stage has started
      and the presenting part of the baby is visible. The second midwife observes the birth and can
      assist the midwife responsible for the birth if needed. An unpublished survey from one
      maternity ward in Sweden showed that most of the midwives appreciated this way of working but
      were uncertain as to whether it actually reduced the prevalence of severe perineal trauma.
      Furthermore, this clinical practice might have negative side-effects or unintended
      consequences. The maternity wards that practise this method have not increased the number of
      midwives. It could be argued that there is a risk that other women in labor will be left
      unattended for longer periods when two midwives assist at births. How midwives share the
      responsibility and communicate are factors that needs to be evaluated scientifically.

      The objective of this trial is to evaluate whether collegial midwifery assistance during the
      second stage reduces perineal trauma grade III-IV.

      Data from the National Birth Register show that 4.1% of first-time mothers suffered severe
      perineal trauma (OASI) in Sweden 2017. To be able to detect a reduction from 4.1 to 2.0% (50%
      reduction) with 80% power and a 95% level of significance, 1052 women in each group will be
      needed. The 50% reduction is based on regional figures after a change in practice and is
      therefore clinically significant. Allowing for a possible 40% drop-out rate including
      possible cases of obstetric emergencies where another midwife will be needed regardless of
      randomization, this will result in 2946 women in total. To ensure that there are no adverse
      side-effects of the intervention interim analyses will be performed every 6 months until the
      end of the trial. In the interim analysis, the distribution of the intervention and standard
      care will be estimated among women with no perineal tears, women diagnosed with a third- or
      fourth-degree tear (OASI), and neonatal outcome (apgar score at 5 minutes and arterial blood
      gas from the nuchal cord).

      Women will be asked to participate in the trial when arriving to the maternity ward. The
      randomization will take place when the woman enters the second stage. It will not be possible
      to blind either women or midwives in this study. The participants will be randomly allocated
      (1:1) to the intervention group or to the standard care group. To allow for equal
      distribution between the groups, block randomization in blocks of ten (five to the
      intervention and five to the control group) will be used.

      After the birth the tear will be diagnosed together with a midwife or an obstetrician who has
      not been involved in the birth. Tears will be sutured according to the guidelines at each
      participating study site. The midwife responsible for the birth will complete a questionnaire
      which will contain questions regarding the woman; labor and birth variables, methods of
      preventing perineal trauma, questions regarding the baby, diagnosis of the tear and how the
      tear was sutured. If a second midwife has been present during the second stage (intervention)
      the responsible midwife will also complete questions on the assistance she got from the
      second midwife and how this assistance was experienced. Data will also be retrieved from the
      participating women's records by using the local database of each study site. When the
      intervention has taken place the second midwife will also complete a questionnaire.

      The women in the trial will be sent a questionnaire one month and one year after the birth.
      The follow-up questionnaire after one month will contain questions regarding their experience
      of the intervention and their experience of the methods used during the second stage and
      women's well-being (EPDS, Pain relief, sexual intercourse resumption, breastfeeding
      initiation), after birth.

      For the one-year follow-up the following validated questionnaires will be used: Pelvic Floor
      Impact Questionnaire (PFIQ7), Pelvic Floor Distress Inventory - short form (PFDI-20), Pelvic
      Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) Female Sexual
      Function Index FSFI, Edinburgh Postnatal Depression Scale (EPDS) and breastfeeding duration.
    

Intervention name(s): Two midwives
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Midwifery intervention; Birth experience; Obstetric anal sphincter injuries; Perineal tears