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

Labor, First Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01546129
• Other study ID #: DOCS001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 1, 2012
• Last updated: March 6, 2012
• Start date: April 2012

Study information

• Verified date: January 2012
• Source: Rabin Medical Center
• Contact: Boris Kaplan, MD, Prof.
• Phone: 972-3-9377534
• Email: bkaplan[@]clalit.org.i l
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, First Stage
• Labor, Second Stage

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on c-section rates			No
Primary	Effects on vaginal operative intervention rates (forceps, vaccum)			No
Primary	Effects on prolonged second stage			No
Primary	Effects on vaginal and Perineum: tears			No
Primary	Effect on episiotomy rate			No
Primary	Effect on labor outcome in premature infants			No
Secondary	Effect on labor duration stage 2 (full dilatation of the cervix until delivery of the baby).			No
Secondary	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)			No
Secondary	Effect on birth trauma (birth canal lacerations): vaginal lesions, perineal lesions			No
Secondary	Effect on labor outcomes in state after c-section			No
Secondary	Effect on pain experience (pain reduction) measured by visual analog scale: use of epidural			No
Secondary	Effect on postpartum vaginal or urethral burn feeling			No
Secondary	Effect on newborn outcomes (APGAR score 1, 5 and 10 min after birth; umbilical cord pH; reduction of newborn trauma)			No