Labor, First StagePhase 3NCT01546129
Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery
A Phase 3 study testing Dianatal Obstetric Gel (Cross-linked polyacrylic acid) in people with Labor, First Stage and Labor, Second Stage, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, First Stage, Labor, Second Stage
- What is being tested?
- Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- contraindications for vaginal delivery
- indications for an amnion infection syndrome
- suspect for fetal malformations
- indications for cephalopelvic disproportion
- severe concomitant diseases of the mother
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, 49100
Boris Kaplan, Prof., 972-3-9377534, bkaplan@clalit.org.i l
Yarin Yogev, MD, 972-50-4065554, yarivyogev@hotmail.com
About this study
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.
Read more
(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
- Being tested
- Dianatal Obstetric Gel (Cross-linked polyacrylic acid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid) |
| Control | No intervention | Standard of care according to the established Guidelines of the Department. Receives: Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, First StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, boris kaplan, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546129
- Sponsor's protocol ID
- DOCS001
- Status last verified
- Jan 2012
- First submitted
- 1 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery
- ClinicalTrials.gov ID
- NCT01546129
- Acronym / sponsor ID
- DOCS001
- Conditions
- Labor, First Stage, Labor, Second Stage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dianatal Obstetric Gel | Experimental | Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)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 |
| Control | No intervention | Device: Dianatal Obstetric Gel (Cross-linked polyacrylic acid)Standard of care according to the established Guidelines of the Department. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- contraindications for vaginal delivery
- indications for an amnion infection syndrome
- suspect for fetal malformations
- indications for cephalopelvic disproportion
- severe concomitant diseases of the mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Control, Dianatal Obstetric Gel |
Primary outcome
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
7 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dianatal Obstetric Gel (Cross-linked polyacrylic acid) in people with Labor, First Stage and Labor, Second Stage, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Kaplan, MD, Prof. (972-3-9377534, bkaplan@clalit.org.i l), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on c-section rates. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.