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Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery

This study is not yet open for participant recruitment.
Verified January 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
boris kaplan, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01546129
First received: March 1, 2012
Last updated: March 6, 2012
Last verified: January 2012
History of Changes
  Purpose

Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2 has been found, both trials did not show a significant increase of perineum integrity.

In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a significant increase of perineal integrity have been shown. No adverse events have been reported.

(see also Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135).

Today's practice- Lubricants are widely used to enable manual vaginal examination during labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage 2 to protect the perineum. It has been shown for the first time that the use of the Dianatal Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the EU markets in 2008.


Condition Intervention Phase
Labor, First Stage
Labor, Second Stage
 Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Effects on c-section rates [ Designated as safety issue: No ]
  • Effects on vaginal operative intervention rates (forceps, vaccum) [ Designated as safety issue: No ]
  • Effects on prolonged second stage [ Designated as safety issue: No ]
  • Effects on vaginal and Perineum: tears [ Designated as safety issue: No ]
  • Effect on episiotomy rate [ Designated as safety issue: No ]
  • Effect on labor outcome in premature infants [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on labor duration stage 2 (full dilatation of the cervix until delivery of the baby). [ Designated as safety issue: No ]
  • Effect on labor duration stage 1 (cervical dilatation of uterus between 4 cm and 10 cm, the beginning of stage 1, i.e. 4 cm dilatation should be evaluated as close as possible within routine examination periods) [ Designated as safety issue: No ]
  • Effect on birth trauma (birth canal lacerations): vaginal lesions, perineal lesions [ Designated as safety issue: No ]
  • Effect on labor outcomes in state after c-section [ Designated as safety issue: No ]
  • Effect on pain experience (pain reduction) measured by visual analog scale: use of epidural [ Designated as safety issue: No ]
  • Effect on postpartum vaginal or urethral burn feeling [ Designated as safety issue: No ]
  • Effect on newborn outcomes (APGAR score 1, 5 and 10 min after birth; umbilical cord pH; reduction of newborn trauma) [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dianatal Obstetric Gel
Standard of care according to the established Guidelines of the Department plus use of Dianatal applied with a vaginal applicator in stage I and stage II of labor
 Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
Dianatal (approx. 30 mL in total) will be intermittently administered to the birth canal after vaginal examination in labor using the Dianatal applicator or the syringe or the fingers. Dianatal Stage I is used during labor stage I, Dianatal Stage 2 is used during stage 2. After rupture of the membranes supplementary Dianatal is applied within 5 to 20 minutes.
No Intervention: Control
Standard of care according to the established Guidelines of the Department.
 Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
Dianatal (approx. 30 mL in total) will be intermittently administered to the birth canal after vaginal examination in labor using the Dianatal applicator or the syringe or the fingers. Dianatal Stage I is used during labor stage I, Dianatal Stage 2 is used during stage 2. After rupture of the membranes supplementary Dianatal is applied within 5 to 20 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Maternal age between 18 and 40 years
  • signed written informed consent,
  • intention for vaginal delivery,
  • nulliparous state or multiparous state
  • singleton baby in vertex presentation
  • estimated birth weight between 1500 g and 4500 g
  • low risk pregnancies at term and late preterm (34 to 42weeks of gestational age)

Exclusion Criteria:

  • contraindications for vaginal delivery
  • indications for an amnion infection syndrome
  • suspect for fetal malformations
  • indications for cephalopelvic disproportion
  • severe concomitant diseases of the mother
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546129

Contacts
Contact: Boris Kaplan, MD, Prof. 972-3-9377534 bkaplan@clalit.org.i​l
Contact: Yarin Yogev, MD 972-50-4065554 yarivyogev@hotmail.com

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah-Tikva, Israel, 49100
Contact: Boris Kaplan, Prof.     972-3-9377534     bkaplan@clalit.org.i​l    
Contact: Yarin Yogev, MD     972-50-4065554     yarivyogev@hotmail.com    
Principal Investigator: Boris Kaplan, Prof.            
Sub-Investigator: Yarin Yogev, MD            
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: boris kaplan, Prof. Boris Kaplan, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01546129     History of Changes
Other Study ID Numbers: DOCS001
Study First Received: March 1, 2012
Last Updated: March 6, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Carbopol 940
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013