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

Clalit Health Services

Status and phase

Unknown

Phase 3

Conditions

Labor, First Stage

Labor, Second Stage

Treatments

Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)

Study type

Interventional

Funder types

Other

Identifiers

NCT01546129

DOCS001

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

180 participants in 2 patient groups

Dianatal Obstetric Gel

Experimental group

Description:

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

Treatment:

Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)

Control

No Intervention group

Description:

Standard of care according to the established Guidelines of the Department.

Treatment:

Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)