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

March 6, 2012 updated by: boris kaplan, Rabin Medical Center

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dianatal Obstetric Gel
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)
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.
No Intervention: Control
Standard of care according to the established Guidelines of the Department.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOCS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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