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The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)

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ClinicalTrials.gov Identifier: NCT02356237
Recruitment Status : Recruiting
First Posted : February 5, 2015
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Bnai Zion Medical Center
Rambam Health Care Campus
Hillel Yaffe Medical Center
Ziv Medical Center
The Baruch Padeh Medical Center, Poriya
Western Galilee Hospital-Nahariya
Information provided by (Responsible Party):
Lena Sagi-Dain, Carmel Medical Center

Brief Summary:

This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular hospital), while the other half will not undergo epitiotomy at all.

Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated between these two groups.


Condition or disease Intervention/treatment Phase
Anal Sphincter Injury Other: No episiotomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Episiotomy on Advanced Perineal Tears and Other Maternal and Fetal Outcomes - Randomized Controlled Multicentric Trial (EPITRIAL)
Study Start Date : June 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: No episiotomy
Episiotomy will not be performed in this group. Deviation from protocol (i.e. episiotomy performance) will be allowed only according to the discretion of obstetrician in charge of the delivery, in cases of unequivocal benefit to the fetus.
Other: No episiotomy
Avoidance of episiotomy

No Intervention: Selective episiotomy
The decision to perform episiotomy in this group will be based on routine delivery care, i.e. indistinguishable from any other delivery not participating in the trial.



Primary Outcome Measures :
  1. Obstetric Anal Sphincter injury [ Time Frame: From the delivery to one hour after delivery ]
    Advanced (3rd and 4th degree) perineal tears, i.e. perineal lacerations involving the anal sphincter, diagnosed by a senior obstetrician


Secondary Outcome Measures :
  1. 1st and 2nd degree perineal tears [ Time Frame: From the delivery to one hour after delivery ]
    1st and 2nd degree perineal tears i.e. lacerations not involving the anal sphincter), diagnosed by an attending accoucher immediately after delivery. Of note, episiotomy will be considered as a 2nd degree tear.

  2. Duration of the second stage of labor [ Time Frame: From beginning of full dilatation to the delivery of the baby ]
    Time in minutes from full dilatation stage of labor until the delivery of the baby

  3. Postpartum hemorrhage [ Time Frame: From delivery to one hour postpartum ]
    Excessive vaginal bleeding (above 500 ml according to the subjective evaluation of the attending accoucher, or associated with hemodynamic instability), from the moment of the delivery to one hour after delivery

  4. Neonatal Apgar score [ Time Frame: From the delivery to five minutes after delivery ]
    One and five minutes Apgar scores

  5. Cord blood pH [ Time Frame: From the delivery to first two minutes after delivery ]
    Cord blood pH - if measured

  6. Need of any neonatal resuscitation procedures [ Time Frame: From the delivery to one hour after delivery ]
  7. Admission to Neonatal Intensive Care Unit (NICU) [ Time Frame: From the delivery to one hour after delivery ]
  8. Shoulder dystocia [ Time Frame: From the delivery of the head to the delivery of the shoulders or longer than 60 seconds interval between the delivery of the head to the delivery of the shoulders ]
    The occurrence of shoulder dystocia, defined as a requirement of obstetrical maneuvers for shoulder delivery, or longer than 60 seconds interval between the delivery of the head to the delivery of the shoulders

  9. Episiotomy performance parameters (Indication for episiotomy performance) [ Time Frame: During suturing (from the delivery to one hour after the delivery) ]
    Indication for episiotomy performance, incision characteristics - i.e. post-suture angle, length and initiation point of the incision, suturing accoucheur profession (midwife/obstetrician) and duration of his/her obstetric experience.

  10. Characteristics of suturing procedure (The duration of suturing procedure, number of suture packs used during the suturing, subjective grading of suturing difficulty and need for extended suturing in operative room) [ Time Frame: During suturing (from the delivery to one hour after the delivery) ]
    The duration of suturing procedure, number of suture packs used during the suturing, subjective grading of suturing difficulty and need for extended suturing in operative room

  11. Postpartum symptoms two days after the delivery (Perineal pain evaluation using 11 points (0-10) Verbal Numeric Scale, urinary retention, perineal infection, perineal hematoma requiring surgical drainage, symptoms of urinary/anal incontinence) [ Time Frame: During the second day after the delivery ]
    Perineal pain evaluation using 11 points (0-10) Verbal Numeric Scale, urinary retention (for more than 6 hours after the delivery/urinary catheter extraction), perineal infection, perineal hematoma requiring surgical drainage, symptoms of urinary/anal incontinence

  12. Phone-call evaluation two months after the delivery [ Time Frame: Two months after the delivery ]
    "Yes or no" questions regarding symptoms of urinary/anal incontinence, perineal complications (infection or dehiscence of perineal scar); timing of resumption of sexual activity; perineal pain and dyspareunia evaluation using 11 points (0-10) Verbal Numeric Scale.

  13. Phone-call evaluation one year after the delivery (Two questionnaires) [ Time Frame: One year after the delivery ]
    Two questionnaires will be filled: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and Pelvic Floor Distress Inventory-20 (PFDI-20)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in labor, or women scheduled for induction of labor, or women attending for a routine follow-up examination during third trimester of pregnancy.
  • First vaginal delivery
  • Singleton pregnancy above 34 gestational weeks
  • Vertex presentation
  • Women who are able to understand and sign the informed consent forms.

Exclusion Criteria:

Absolute contraindications for vaginal delivery (e.g. placenta previa, fetal macrosomia above 4.5 kg, genital herpes)


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): NCT02356237


Contacts
Contact: Lena Sagi-Dain, M.D. +972-506265842 lena2303@gmail.com
Contact: Orna Caspin +972-542444812 ornacaspin@gmail.com

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Shlomi Sagi, MD    +972526484747    mdsagi.s@gmail.com   
Contact: Orna Caspin    +972542444812    ornacaspin@gmail.com   
Sponsors and Collaborators
Lena Sagi-Dain
Bnai Zion Medical Center
Rambam Health Care Campus
Hillel Yaffe Medical Center
Ziv Medical Center
The Baruch Padeh Medical Center, Poriya
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Shlomi Sagi, M.D. Head of Obstetrics and Gynecology department, Bnai-Zion Medical Center, Haifa, Israel
Principal Investigator: Reuven Keidar, M.D. Deputy of Obstetrics and Gynecology department, Carmel Medical Center, Haifa, Israel
Principal Investigator: Ido Solt, M.D. Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel
Principal Investigator: Asnat Walfisch, M.D. Department of Obstetrics and Gynecology, Hillel Yaffe Medical Center, Hadera, Israel
Principal Investigator: Dmitry Chuyun, M.D. Department of Obstetrics and Gynecology, The Baruch Padeh Medical Center, Poriya, Israel
Principal Investigator: David Peleg, M.D. Department of Obstetrics and Gynecology, Ziv Medical Center, Tzfat, Israel
Principal Investigator: Oleg Shnaider, M.D. Department of Obstetrics and Gynecology, Western Galilee Medical Center, Nahariya, Israel

Publications:
Responsible Party: Lena Sagi-Dain, Senior Obstetrician, Department of Obstetrics and Gynecology, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02356237     History of Changes
Other Study ID Numbers: 125-14BNZ
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lena Sagi-Dain, Carmel Medical Center:
Episiotomy
Obstetric Anal Sphincter Injury