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

NCT01546129 | Unknown Phase 3

• 1 other identifier: DOCS001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, First Stage; Labor, Second Stage

Outcome Measures

Primary Outcomes (6)

• 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 (7)

• 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

Study Arms (2)

Dianatal Obstetric Gel

EXPERIMENTAL

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)

Control

NO INTERVENTION

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

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

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.

Control; Dianatal Obstetric Gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• contraindications for vaginal delivery
• indications for an amnion infection syndrome
• suspect for fetal malformations
• indications for cephalopelvic disproportion
• severe concomitant diseases of the mother

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Central Study Contacts

Boris Kaplan, MD, Prof.

CONTACT

972-3-9377534; bkaplan@clalit.org.i l

Yarin Yogev, MD

CONTACT

972-50-4065554; yarivyogev@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Boris Kaplan

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 7, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Last Updated: March 7, 2012

Record last verified: 2012-01

Locations

IL (1)