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Trial record 3 of 50204 for:    will | Recruiting, Not yet recruiting, Available Studies

One Plus One Equals Two, Will That do? (Oneplus)

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ClinicalTrials.gov Identifier: NCT03770962
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Region Skane

Brief 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.


Condition or disease Intervention/treatment Phase
Sphincter (Anal); Perineal Rupture, Obstetric Perineal Tear Pelvic Floor Disorders Experience, Life Second Stage of Labor Behavioral: Two midwives Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2946 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The statistician who performs the statistical analysis will be blinded.
Primary Purpose: Prevention
Official Title: One Plus One Equals Two - Will That do? A Randomized Controlled Trial to Evaluate Collegial Midwifery Practice to Prevent Perineal Trauma
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: 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 observe the birth or give any assistance needed.
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.

No Intervention: One midwife
This is standard care. One midwife is responsible for the care of the woman and her unborn baby during labor and birth.



Primary Outcome Measures :
  1. Number of women with obstetric anal sphincter injury [ Time Frame: 4 hour ]
    Tear of the external and/or internal anal sphincter at any degree, ICD-10 O70.2 and O70.3.


Secondary Outcome Measures :
  1. Number of women with perineal tear grade II [ Time Frame: 4 hour ]
    Tear of the muscles of the perineum and/or deeper vaginal tears. ICD-10 O70.1

  2. Number of women with postpartum bleeding [ Time Frame: 6 hour ]
    Postpartum bleeding in millilitres evaluated 6 hours after birth. ICD-10 O72.0, O72.1 (O72.1a, O72.1b)

  3. Birthposition at the time of birth [ Time Frame: 2 hours ]
    The position of the woman when giving birth as recorded in the local birth register

  4. Number of women with an episiotomy [ Time Frame: 4 hour ]
    Number of women who had an episiotomy performed during birth

  5. Number of women with perineal injury subtypes [ Time Frame: 4 hour ]
    Labial lacerations, periurethral tears, perinal tears grade I, and superficial vaginal tears. ICD-10 070.0

  6. Apgar scores at birth, 1 and 5 min after birth [ Time Frame: 10 minutes ]
    Apgar score assessed by the midwife a 1,5.10 minutes after the baby is born

  7. pH in umbilical artery [ Time Frame: Blood sample is drawn from the umbilical cord within 1 minute after the birth of the baby and evaluated within 30 minutes ]
    Arterial pH in the umbilical cord

  8. Breastfeeding within 2 hours after birth [ Time Frame: 2 hours ]
    Number of women who breastfeed within 2 hours after birth

  9. Number of women with an assisted Instrumental delivery [ Time Frame: Recorded after birth (2 hours) ]
    Number of women with an instrumental delivery (vacuum extraction or forceps)

  10. Midwives experiences of the intervention [ Time Frame: One month ]
    Midwives no 1 and no 2 will complete a study record after birth. The study record will contain question regarding what midwife no 2 assisted with during the second stage of labour and how it was perceived by midwife no 1

  11. Women's experiences of midwifery methods used during the second stage of labor [ Time Frame: One month ]
    Study specific questions sent to women one month after the birth. A questionnaire with questions regarding midwifery methods used (YES or NO) during the second stage of labor and how they were perceived by the participating women. Questions with Likert scale answers.

  12. Number of women with urinary incontinence 1 year after birth [ Time Frame: 1 year ]
    Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used.

  13. Number of women with anal incontinence 1 year after birth [ Time Frame: 1 year ]
    Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFIQ) will be used

  14. Number of women with sexual dysfunction related to pelvic floor symptoms 1 year after birth [ Time Frame: 1 year ]
    Questionnaire 12 months after the birth. Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) will be used

  15. Number of women with pelvic organ prolapse symptoms 1 year after birth [ Time Frame: 1 year ]
    Questionnaire 12 months after the birth. Pelvic Floor Impact Questionnaire (PFDI-20) will be used

  16. Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale [ Time Frame: one month ]
    Depressive symptoms 1 month after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)

  17. Number of women who scored 12 point or above on the Edinburgh Postnatal Depression Scale [ Time Frame: 1 year ]
    Depressive symptoms 1 year after birth as reported on the Edinburgh Postnatal Depression Scale (EPDS)



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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nulliparous women
  • Primiparous women with one previous cesarean section who plan for a vaginal birth
  • >37+0 week of gestational age

Exclusion Criteria:

  • Multiparous women
  • Twin pregnancies
  • Planned breech delivery
  • Preterm birth
  • Nulliparous women with planned elective cesarean section
  • Not able to understand oral and written information regarding the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770962


Contacts
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Contact: Christine Rubertsson, Professor +46708693993 christine.rubertsson@med.lu.se
Contact: Malin Edqvist, RNM, PhD +46709921487 malin.edqvist@med.lu.se

Locations
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Sweden
Lund Delivery Ward, SUS Region Skåne Not yet recruiting
Lund, Skåne, Sweden
Malmö Delivery Ward, SUS Region Skåne Not yet recruiting
Malmö, Skåne, Sweden
PO Pregnancy and Birth, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Malin Edqvist, RNM, PhD    +46709921487    malin.edqvist@med.lu.se   
Sponsors and Collaborators
Region Skane
Karolinska University Hospital
Investigators
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Principal Investigator: Christine Rubertsson, Professor Institution of Health Sciences, The Faculty of Medicine, Lund University
Study Chair: Pia Teleman, Ass.prof Region Skåne SUS
  Study Documents (Full-Text)

Documents provided by Region Skane:
Study Protocol  [PDF] December 3, 2018


Additional Information:
Publications:

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03770962     History of Changes
Other Study ID Numbers: 2018/476
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Skane:
Midwifery intervention
Birth experience
Obstetric anal sphincter injuries
Perineal tears

Additional relevant MeSH terms:
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Rupture
Pelvic Floor Disorders
Wounds and Injuries
Pregnancy Complications