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

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor, First Stage, Labor, Second Stage

Intervention / Treatment
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* Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dianatal Obstetric Gel<br>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)<br>* 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.<br>|
| No Intervention: Control<br>Standard of care according to the established Guidelines of the Department. | Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  |