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

Rabin Medical Center180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Labor, First Stage Labor, Second Stage

Interventions

Dianatal Obstetric Gel (Cross-linked polyacrylic acid)DEVICE

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

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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)