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.

Study Overview

• Status: Unknown
• Conditions: Labor, First Stage; Labor, Second Stage
• Intervention / Treatment: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effects on c-section rates
Effects on vaginal operative intervention rates (forceps, vaccum)
Effects on prolonged second stage
Effects on vaginal and Perineum: tears
Effect on episiotomy rate
Effect on labor outcome in premature infants

Secondary Outcome Measures

Outcome Measure
Effect on labor duration stage 2 (full dilatation of the cervix until delivery of the baby).
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)
Effect on birth trauma (birth canal lacerations): vaginal lesions, perineal lesions
Effect on labor outcomes in state after c-section
Effect on pain experience (pain reduction) measured by visual analog scale: use of epidural
Effect on postpartum vaginal or urethral burn feeling
Effect on newborn outcomes (APGAR score 1, 5 and 10 min after birth; umbilical cord pH; reduction of newborn trauma)

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: DOCS001