Does the Use of Dianatal Reduce the Rate of Episiotomy and Vaginal Tears in Birth?
Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJuly 8, 2015
July 1, 2015
1.7 years
June 30, 2015
July 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of women who will go through episiotomy and vaginal tears during birth
A year and a half
Secondary Outcomes (3)
Time of delivery
A year and a half
Number of women who will have post-delivery complications such as fever after childbirth, vaginal hematomas requiring intervention, long hospitalizations after birth.
A year and a half
Number of spontaneous vaginal births (that are not Instrumental deliveries)
A year and a half
Study Arms (2)
Control group
NO INTERVENTIONWomen who will not be using this medicine that is checked.
Study group
EXPERIMENTALWomen who will use DIANATAL according to manufacturer's protocol from the stage of active labor.
Interventions
Eligibility Criteria
You may qualify if:
- Women on their first Childbirth
- Singleton pregnancy
- Over 37 weeks of pregnancy
- In active labor
- Women who intend to have a vaginally birth
- Women aged 18-45
You may not qualify if:
- Multiple pregnancy
- Births before 37 weeks
- History of tear degree III or more
- Women who intended to give birth by Caesarean section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Eason E, Labrecque M, Wells G, Feldman P. Preventing perineal trauma during childbirth: a systematic review. Obstet Gynecol. 2000 Mar;95(3):464-71. doi: 10.1016/s0029-7844(99)00560-8.
PMID: 10711565BACKGROUNDRiener R, Leypold K, Brunschweiler A, Schaub A, Bleul U, Wolf P. Quantification of friction force reduction induced by obstetric gels. Med Biol Eng Comput. 2009 Jun;47(6):617-23. doi: 10.1007/s11517-009-0460-1. Epub 2009 Feb 24.
PMID: 19238473BACKGROUNDSchaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. J Perinat Med. 2008;36(2):129-35. doi: 10.1515/JPM.2008.024.
PMID: 18211256BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 8, 2015
Study Start
August 1, 2015
Primary Completion
April 1, 2017
Study Completion
August 1, 2017
Last Updated
July 8, 2015
Record last verified: 2015-07