Duration of Labor.Phase 3NCT02362139
The Impact of Papaverine on First Stage of Labor
A Phase 3 study testing The study group in people with Duration of Labor., run by eran ashwal.
Trial summary
In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician. The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Duration of Labor.
- What is being tested?
- The study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy.
- 37-41 weeks of gestation.
- Women who enter delivery room in spontaneous labor during the latent phase of labor (cervical dilatation <4cm).
- Maternal age between 18 and 45.
Who cannot join
- Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm).
- Women with previous cesarean section
- Women with premature rupture of membranes (PROM)
Trial locations and contacts
No sites are listed yet.
About this study
In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician.
The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of labor.
Read the detailed description
Cervical dilatation rate and the duration of delivery are key issues in the management of labor. Protracted labor is known to be associated with a range of potential maternal and neonatal complications, including higher rate of post partum hemorrhage (PPH), cesarean sections, instrumental deliveries, maternal or neonatal infections and neonatal pulmonary asphyxia [1,2,3]. Thus, there is a rationale for reducing the duration of labor in order to reduce adverse pregnancy outcome.
Active management of labor as was demonstrated by O'driscoll et al. was found to be effective in shortening the duration of delivery [1, 4]. There is a variety of mechanical and medical methods for labor induction and augmentation. Mechanical methods include artificial rupture of membranes (amniotomy), with or without the use of Pitocin [5, 6], manual sweeping of the amniotic membranes which promotes the release of prostaglandins [7], and extra-amniotic balloon [8]. Medical methods such as prostaglandins and Pitocin are well studied and were found to reduce the duration of labor.
Papaverine and its derivatives have been studied in the nineties of the last century and were found to be effective in reducing the duration of the first stage of labor [9, 10, 11]. Drotaverine hydrochloride is an analog of Papaverine and a selective inhibitor of phosphodiesterase 4. It was found to be effective in accelerating cervical dilatation through smooth muscle relaxation.
In a prospective randomized controlled trial that included 146 women in spontaneous vaginal delivery, Madhu et al. have shown that women who were treated with Drotaverine through the latent phase of labor, had significantly shorter duration of time between the administration of the medication and the delivery of the fetus, compared to women that were treated with placebo (182 minutes compared to 245 minutes with placebo). Moreover, the cervical dilatation rate in the Drotaverine group was significantly higher than this in the placebo group (3 centimeters per hour (cm\Hr) compared to 1.4 cm\Hr) [9]. These findings are in agreement with Shmara et al. that have also demonstrated a significant reduction in the duration of labor and a significant acceleration in cervical dilatation rate with Drotaverine administration compared to placebo. In this study 100% of women who were treated with Drotaverine in the latent phase of labor have delivered in 6 hours from the administration, compared to 46% in the placebo group [10].
Only few previous studies have addressed the influence of Papaverine administration on the duration of labor [9-12], and these studies are limited by small sample size, and different administration protocols. Moreover, in part of these studies, the use of Papaverine was not separate from the use of other methods for labor augmentation such as amniotomy or Pitocin administration, what could bias their results.
In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician.
The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of labor.
- Conditions
- Duration of Labor.
- Being tested
- The study group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study groupDrug
Also called Papverine
200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation<4cm).
| Study group | Role | What they receive |
|---|---|---|
| The study group | Experimental | 200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation<4cm). Receives: Drug: The study group |
| The control group | No intervention | 200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were not treated with IM Papverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of time between Papaverine administration and delivery.
Measured: 24 month
Secondary outcomes (3)
Duration of second and third stages of labor
Measured: 24 month
Cervical dilatation rate (cm\Hr)
Measured: 24 month
Papaverine adverse outcome
Papaverine Side effects: nausea and vomiting, palpitations, maternal tachycardia (>100 BpM), neonatal tachycardia (base line> 160 BpM for 10 minutes or more), headache.
- Monitoring for side effects will be performed every hour
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of Labor.Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eran ashwal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, eran ashwal, Rabin Medical Center
- Investigators
- Eran Ashwal, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362139
- Sponsor's protocol ID
- 0463-13-RMC
- Status last verified
- Feb 2015
- First submitted
- 8 Feb 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Papaverine on First Stage of Labor
- ClinicalTrials.gov ID
- NCT02362139
- Acronym / sponsor ID
- 0463-13-RMC
- Conditions
- Duration of Labor.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- eran ashwalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 12 Feb 2015 (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.
In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician.
The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of labor.
Detailed description
Cervical dilatation rate and the duration of delivery are key issues in the management of labor. Protracted labor is known to be associated with a range of potential maternal and neonatal complications, including higher rate of post partum hemorrhage (PPH), cesarean sections, instrumental deliveries, maternal or neonatal infections and neonatal pulmonary asphyxia [1,2,3]. Thus, there is a rationale for reducing the duration of labor in order to reduce adverse pregnancy outcome.
Active management of labor as was demonstrated by O'driscoll et al. was found to be effective in shortening the duration of delivery [1, 4]. There is a variety of mechanical and medical methods for labor induction and augmentation. Mechanical methods include artificial rupture of membranes (amniotomy), with or without the use of Pitocin [5, 6], manual sweeping of the amniotic membranes which promotes the release of prostaglandins [7], and extra-amniotic balloon [8]. Medical methods such as prostaglandins and Pitocin are well studied and were found to reduce the duration of labor.
Papaverine and its derivatives have been studied in the nineties of the last century and were found to be effective in reducing the duration of the first stage of labor [9, 10, 11]. Drotaverine hydrochloride is an analog of Papaverine and a selective inhibitor of phosphodiesterase 4. It was found to be effective in accelerating cervical dilatation through smooth muscle relaxation.
In a prospective randomized controlled trial that included 146 women in spontaneous vaginal delivery, Madhu et al. have shown that women who were treated with Drotaverine through the latent phase of labor, had significantly shorter duration of time between the administration of the medication and the delivery of the fetus, compared to women that were treated with placebo (182 minutes compared to 245 minutes with placebo). Moreover, the cervical dilatation rate in the Drotaverine group was significantly higher than this in the placebo group (3 centimeters per hour (cm\Hr) compared to 1.4 cm\Hr) [9]. These findings are in agreement with Shmara et al. that have also demonstrated a significant reduction in the duration of labor and a significant acceleration in cervical dilatation rate with Drotaverine administration compared to placebo. In this study 100% of women who were treated with Drotaverine in the latent phase of labor have delivered in 6 hours from the administration, compared to 46% in the placebo group [10].
Only few previous studies have addressed the influence of Papaverine administration on the duration of labor [9-12], and these studies are limited by small sample size, and different administration protocols. Moreover, in part of these studies, the use of Papaverine was not separate from the use of other methods for labor augmentation such as amniotomy or Pitocin administration, what could bias their results.
In the investigators institution, there is a wide use of Papaverine in delivery room, but this use is optional, and is left to the discretion of the physician.
The aim of the investigators study is to prospectively evaluate the influence of Papaverine administration in the latent phase of labor, on the duration of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group | Experimental | Drug: The study group200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation<4cm). |
| The control group | No intervention | –200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were not treated with IM Papverine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy.
- 37-41 weeks of gestation.
- Women who enter delivery room in spontaneous labor during the latent phase of labor (cervical dilatation <4cm).
- Maternal age between 18 and 45.
Key exclusion criteria (3 listed)
- Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm).
- Women with previous cesarean section
- Women with premature rupture of membranes (PROM)
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 |
|---|---|---|
| The study groupAlso: Papverine200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation<4cm). | Drug | The study group |
Primary outcome
The duration of time between Papaverine administration and delivery.
Time frame: 24 month
3 secondary outcomes
Duration of second and third stages of labor
Time frame: 24 month
Cervical dilatation rate (cm\Hr)
Time frame: 24 month
Papaverine adverse outcome
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Eran Ashwal, MD principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The study group in people with Duration of Labor., run by eran ashwal.
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 4 inclusion and 3 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Eran Ashwal, MD (972-39377218, rmc@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of time between Papaverine administration and delivery. (time frame: 24 month). 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 12 Feb 2015.