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Trial record 6 of 72 for:    "The Swedish Research Council" [Exact]

Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women (EVA)

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ClinicalTrials.gov Identifier: NCT02643108
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Sophia Brismar Wendel, Karolinska Institutet

Brief Summary:
Non-parous women with a live singleton pregnancy in cephalic presentation past 34 gestational weeks will be randomized to lateral episiotomy or no episiotomy when operative vaginal delivery by vacuum extraction is indicated. Primary outcome is clinically diagnosed obstetric anal sphincter injury (OASIS) of any degree.

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Fecal Incontinence Dystocia Fetal Hypoxia Procedure: Lateral episiotomy Not Applicable

Detailed Description:

The study has started at Danderyd Hospital. Danderyd Hospital is a large teaching hospital affiliated to the Karolinska Institute in Stockholm, Sweden. Danderyd Hospital attends approximately 7 000 deliveries annually, of which 330 are vacuum extractions in non-parous women. Other hospitals in Stockholm County and other parts of Sweden are invited to participate in the study.

Informed consent is collected from non-parous women with a singelton, live fetus in cephalic presentation, with a planned vaginal delivery and without previous gynecological surgery due to incontinence or prolapse. Women can be approached at any time from gestational week 25 until delivery, unless they are in severe pain or discomfort, there is not enough time to consider the information, or there is a language barrier. The informed consent form is kept at the receiving research department and a note of consent/no consent is made in the obstetrical medical file, which pops up every time the file is opened.

At indication for vacuum extraction, the patient's consent is confirmed verbally and allocation is made by opaque envelopes on the vacuum extraction equipment mobile cart. Randomization is performed 1:1 in blocks of 4 by an external organization (Karolinska Trial Alliance).

Lateral episiotomy is performed according to the intervention description. Total sample size has been calculated to 1400 women, if a reduction in OASIS prevalence from today's 12.2% to 7.7% in operative vaginal deliveries is to be detected (estimated drop-out rate 3% for the primary outcome). The women will be recruited over a maximum of 3 years. An interim analysis will be performed after 350 randomized women to each arm, since a 50% reduction to less than 6.1% sphincter tears could be detected with less than 5% risk of a type-1 error at this sample size. If such a reduction is seen, the study will be closed.

Data is collected prospectively through Case Record Forms and the obstetrical medical file Obstetrix (Cerner Sverige AB), which covers approximately 98% of deliveries with complete data, and the Swedish Pregnancy Register covering the whole of Sweden from 2015 as well as the (optional) Swedish Obstetrical Tear Register, which Danderyd Hospital is a part of since 2014. From the Obstetrical Tear Register, questionnaires are sent out in paper form or electronically to patients with a diagnosed anal sphincter tear at delivery, 8 weeks and 12 months after delivery. The same questionnaires is sent out electronically in the follow-up of the study participants regardless of randomization or result (sphincter tear or not). In addition, the participants will be sent questionnaires regarding birth satisfaction (BSS-R and CEQ 2.0) at 8 weeks after delivery and questionnaires regarding sexual function (FSFI and FSDS) and quality of life (Euro-QoL-5D) at delivery and after 12 months.

A follow-up from registers regarding mode of delivery and prevalence of episiotomy and OASIS in subsequent births will be performed at 2 years, 5 years, and 10 years after the index birth.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Lateral episiotomy
Lateral episiotomy (left or right) is performed by the attending physician or assisting midwife at crowning of the fetal head in operative vaginal delivery by vacuum extraction. Regular manual perineal support is applied.
Procedure: Lateral episiotomy
When the woman is randomized to episiotomy, lateral episiotomy is performed with scissors on the left or right side of the vaginal opening. Origin of incision is 1.5 - 2.0 cm from the midline/posterior forchette and is cut 3.0 cm or more towards the ischial tuberosity at an angle of 60 degrees from the midline.

No Intervention: No episiotomy
No episiotomy is performed during operative vaginal delivery. The woman may tear spontaneously. Regular manual perineal support is applied.



Primary Outcome Measures :
  1. Obstetrical anal sphincter injury [ Time Frame: 1 hour ]
    Rupture or tear of the external and/or internal anal sphincter at any degree (third and fourth degree perineal tear); International Classification of Diseases (ICD)-10 O70.2 or O70.3.


Secondary Outcome Measures :
  1. Other degree of perineal or vaginal tear [ Time Frame: 1 hour ]
    Rupture, tear or hematoma in the perineum or vagina; International Classification of Diseases (ICD)-10 O70.0, O70.1, O70.9, O71.4-9.

  2. Maternal blood loss at delivery [ Time Frame: 6 hours ]
    Estimated blood loss in milliliters through weighing of sheets and drapes during and up to 6 hours after delivery.

  3. Neonatal scalp injury [ Time Frame: 24 hours ]
    Prevalence (number of patients) of scalp injury to the neonate after instrumental delivery, such as open wounds, cephalic hematoma, subgaleal hematoma, and intracranial hemorrhage, according to diagnose by neonatologist.

  4. Pain [ Time Frame: 1 day, 2 months, 1 year ]
    Questionnaire at baseline (first day post partum), 8 weeks and 12 months after delivery through the VAS scale (0-10) and at 2 months through the Swedish Obstetrical Tear Register: number of days using analgetic medication.

  5. Birthing experience [ Time Frame: 2 months ]
    Questionnaire at 8 weeks after delivery regarding patient satisfaction using the Birth Satisfaction Scale Revised (short form) and the Childbirth Experience Questionnaire 2.0.

  6. Anal incontinence [ Time Frame: 2 months, 1 year, and 5 years ]
    Questionnaire at baseline, 8 weeks, 1 year, and 5 years after delivery through the Swedish Obstetrical Tear Register regarding anal continence function (Wexner score based).

  7. Sexual function [ Time Frame: 1 year and 5 years ]
    Questionnaire at baseline (first day post partum), 1 year, and 5 years after delivery through the Swedish Obstetrical Tear Register, as well as FSFI and FSDS Questionnaires.

  8. Pelvic organ prolapse symptoms [ Time Frame: 1 year and 5 years ]
    Questionnaire at baseline, 1 year, and 5 years after delivery through the Swedish Obstetrical Tear Register regarding symptoms of pelvic organ prolapse.

  9. Quality of life [ Time Frame: 1 year ]
    Assessment of QoL by questionnaire at baseline and 1 year using the Euro-QoL-5D

  10. Mode of delivery in subsequent birth [ Time Frame: 2 years, 5 years and 10 years ]
    Register data will be extracted from the Swedish Pregnancy Register.

  11. Prevalence of obstetrical anal sphincter injury in subsequent birth [ Time Frame: 2 years, 5 years and 10 years ]
    Register data will be extracted from the Swedish Pregnancy Register.

  12. Prevalence of episiotomy in subsequent birth [ Time Frame: 2 years, 5 years and 10 years ]
    Register data will be extracted from the Swedish Pregnancy Register.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primiparae 18 years old or more, able to give a written informed consent in Swedish, with a live singleton pregnancy, in a cephalic presentation over 34 completed gestational weeks with a medical indication of operative vaginal delivery (vacuum extraction).

Exclusion Criteria:

  • Previous vaginal or perineal surgery for prolapse or incontinence, any contra-indication to operative vaginal delivery (ie fetal disorder or malformation).

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): NCT02643108


Contacts
Contact: Sophia Brismar Wendel, MD, PhD +46812358564 sophia.brismar-wendel@sll.se
Contact: Maria Persson, MD, PhD +46812355000 maria.k.persson@sll.se

Locations
Sweden
Danderyd Hospital Recruiting
Stockholm, Sweden
Contact: Sophia Brismar Wendel, MD, PhD    0046722024895    sophia.brismar-wendel@sll.se   
Contact: Helen Fagraeus, Midwife    0046812355000    helen.fagraeus@sll.se   
Principal Investigator: Sophia Brismar Wendel, MD, PhD         
Sub-Investigator: Sandra Bergendahl, MD         
Sub-Investigator: Victoria Ankarcrona, MD         
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
Principal Investigator: Sophia Brismar Wendel, MD, PhD Karolinska Institutet Danderyd Hospital

Publications:
Responsible Party: Sophia Brismar Wendel, MD, PhD, Dept of Women's health, Danderyd Hospital, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02643108     History of Changes
Other Study ID Numbers: 2015/1238-31/2
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sophia Brismar Wendel, Karolinska Institutet:
Lateral episiotomy
Obstetrical anal sphincter injury
Vacuum extraction
Anal incontinence

Additional relevant MeSH terms:
Hypoxia
Fecal Incontinence
Pelvic Floor Disorders
Dystocia
Fetal Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pregnancy Complications
Obstetric Labor Complications
Fetal Diseases