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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
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

March 1, 2012
March 6, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01546129 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery
Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Labor, First Stage
  • Labor, Second Stage
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.
  • 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
    Intervention: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
  • No Intervention: Control
    Standard of care according to the established Guidelines of the Department.
    Intervention: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact: Boris Kaplan, MD, Prof. 972-3-9377534 bkaplan@clalit.org.i​l
Contact: Yarin Yogev, MD 972-50-4065554 yarivyogev@hotmail.com
Israel
 
NCT01546129
DOCS001
Not Provided
boris kaplan, Rabin Medical Center
Rabin Medical Center
Not Provided
Not Provided
Rabin Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP