One Plus One Equals Two, Will That do?

NCT03770962 | Completed

• 1 other identifier: 2018/476
• Study Type: interventional
• Target: 3,058
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Midwifery intervention; Birth experience; Obstetric anal sphincter injuries; Perineal tears

Outcome Measures

Primary Outcomes (1)

• Number of women with obstetric anal sphincter injury

  Tear of the external and/or internal anal sphincter at any degree, ICD-10 O70.2 and O70.3.

  4 hour

Secondary Outcomes (17)

• Number of women with perineal tear grade II

  4 hour

• Number of women with postpartum bleeding

  6 hour

• Birthposition at the time of birth

  2 hours

• Number of women with an episiotomy

  4 hour

• Number of women with perineal injury subtypes

  4 hour

Study Arms (2)

Two midwives

EXPERIMENTAL

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

One midwife

NO INTERVENTION

This is standard care. One midwife is responsible for the care of the woman and her unborn baby during labor and birth.

Interventions

Two midwives BEHAVIORAL

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.

Two midwives

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Karolinska University Hospital: collaborator

Study Sites (4)

Lund Delivery Ward, SUS Region Skåne

Lund, Skåne County, Sweden

Location

Malmö Delivery Ward, SUS Region Skåne

Malmo, Skåne County, Sweden

Location

Karlstad delivery ward

Karlstad, Värmland County, Sweden

Location

PO Pregnancy and Birth, Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (21)

• Baghestan E, Irgens LM, Bordahl PE, Rasmussen S. Trends in risk factors for obstetric anal sphincter injuries in Norway. Obstet Gynecol. 2010 Jul;116(1):25-34. doi: 10.1097/AOG.0b013e3181e2f50b.

  PMID: 20567164 BACKGROUND

• Edqvist M, Hildingsson I, Mollberg M, Lundgren I, Lindgren H. Midwives' Management during the Second Stage of Labor in Relation to Second-Degree Tears-An Experimental Study. Birth. 2017 Mar;44(1):86-94. doi: 10.1111/birt.12267. Epub 2016 Nov 14.

  PMID: 27859542 BACKGROUND

• Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.

  PMID: 15507941 BACKGROUND

• Rathfisch G, Dikencik BK, Kizilkaya Beji N, Comert N, Tekirdag AI, Kadioglu A. Effects of perineal trauma on postpartum sexual function. J Adv Nurs. 2010 Dec;66(12):2640-9. doi: 10.1111/j.1365-2648.2010.05428.x. Epub 2010 Aug 23.

  PMID: 20735499 BACKGROUND

• Tegerstedt G, Miedel A, Maehle-Schmidt M, Nyren O, Hammarstrom M. Obstetric risk factors for symptomatic prolapse: a population-based approach. Am J Obstet Gynecol. 2006 Jan;194(1):75-81. doi: 10.1016/j.ajog.2005.06.086.

  PMID: 16389012 BACKGROUND

• Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. doi: 10.1002/ca.10034.

  PMID: 12203375 BACKGROUND

• Schei B, Johannessen HH, Rydning A, Sultan A, Morkved S. Anal incontinence after vaginal delivery or cesarean section. Acta Obstet Gynecol Scand. 2019 Jan;98(1):51-60. doi: 10.1111/aogs.13463. Epub 2018 Oct 29.

  PMID: 30204238 BACKGROUND

• Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.

  PMID: 16411998 BACKGROUND

• Raisanen S, Vehvilainen-Julkunen K, Cartwright R, Gissler M, Heinonen S. A prior cesarean section and incidence of obstetric anal sphincter injury. Int Urogynecol J. 2013 Aug;24(8):1331-9. doi: 10.1007/s00192-012-2006-6. Epub 2012 Dec 5.

  PMID: 23212242 BACKGROUND

• Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol Scand. 2009;88(12):1365-72. doi: 10.3109/00016340903295626.

  PMID: 19852569 BACKGROUND

• Elvander C, Ahlberg M, Edqvist M, Stephansson O. Severe perineal trauma among women undergoing vaginal birth after cesarean delivery: A population-based cohort study. Birth. 2019 Jun;46(2):379-386. doi: 10.1111/birt.12402. Epub 2018 Oct 22.

  PMID: 30350424 BACKGROUND

• Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.

  PMID: 28608597 BACKGROUND

• Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter tears during delivery. Obstet Gynecol. 2008 May;111(5):1053-7. doi: 10.1097/AOG.0b013e31816c4402.

  PMID: 18448735 BACKGROUND

• Basu M, Smith D, Edwards R; STOMP project team. Can the incidence of obstetric anal sphincter injury be reduced? The STOMP experience. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:55-9. doi: 10.1016/j.ejogrb.2016.04.033. Epub 2016 Apr 30.

  PMID: 27164486 BACKGROUND

• Basu M, Smith D. Long-term outcomes of the Stop Traumatic OASI Morbidity Project (STOMP). Int J Gynaecol Obstet. 2018 Sep;142(3):295-299. doi: 10.1002/ijgo.12565. Epub 2018 Jul 5.

  PMID: 29885253 BACKGROUND

• Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.

  PMID: 1764149 BACKGROUND

• Kopas ML. A review of evidence-based practices for management of the second stage of labor. J Midwifery Womens Health. 2014 May-Jun;59(3):264-76. doi: 10.1111/jmwh.12199.

  PMID: 24850283 BACKGROUND

• Edqvist M, Ajne G, Teleman P, Tegerstedt G, Rubertsson C. Postpartum perineal pain and its association with sub-classified second-degree tears and perineal trauma-A follow-up of a randomized controlled trial. Acta Obstet Gynecol Scand. 2024 Nov;103(11):2314-2323. doi: 10.1111/aogs.14938. Epub 2024 Aug 16.

  PMID: 39150169 DERIVED

• Haggsgard C, Edqvist M, Teleman P, Tern H, Rubertsson C. Impact of collegial midwifery assistance during second stage of labour on women's experience: a follow-up from the Swedish Oneplus randomised controlled trial. BMJ Open. 2024 Jul 27;14(7):e077458. doi: 10.1136/bmjopen-2023-077458.

  PMID: 39067883 DERIVED

• Haggsgard C, Rubertsson C, Teleman P, Edqvist M. Informed consent to midwifery practices and interventions during the second stage of labor-An observational study within the Oneplus trial. PLoS One. 2024 Jun 12;19(6):e0304418. doi: 10.1371/journal.pone.0304418. eCollection 2024.

  PMID: 38865296 DERIVED

• Edqvist M, Dahlen HG, Haggsgard C, Tern H, Angeby K, Tegerstedt G, Teleman P, Ajne G, Rubertsson C. One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma 1. Trials. 2020 Nov 23;21(1):945. doi: 10.1186/s13063-020-04837-7.

  PMID: 33225972 DERIVED

Related Links

• The Swedish birthregister. Annual Report 2017 (Swedish)
• Midwives' experiences of collegial presence during the second stage of labour (Swedish)
• The Management of Third- and Fourth-Degree Perineal Tears. RCOG Green-top Guideline No.29

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Christine Rubertsson, Professor

  Institution of Health Sciences, The Faculty of Medicine, Lund University

  PRINCIPAL INVESTIGATOR

• Pia Teleman, Ass.prof

  Region Skåne SUS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The statistician who performs the statistical analysis will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 10, 2018
• Study Start: December 10, 2018
• Primary Completion: March 21, 2020
• Study Completion: July 13, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)