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

Phase 3

• Conditions: Labor, First Stage; Labor, Second Stage
• Interventions: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)

• Registration Number: NCT01546129
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Last Update Submitted: 2012-03-06
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07
• Study Start: 2012-04
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dianatal Obstetric Gel	Dianatal Obstetric Gel (Cross-linked polyacrylic acid)	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
Control	Dianatal Obstetric Gel (Cross-linked polyacrylic acid)	Standard of care according to the established Guidelines of the Department.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah-Tikva, Israel