Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term PrimigravidaePhase 2NCT01236651
Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
A Phase 2 study testing Meperidine and Drotaverine in people with Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
- What is being tested?
- Meperidine and Drotaverine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 2
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy.
- Term gestation i.e, 38-41 weeks.
- Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
- Vertex presentation with occipito anterior position.
- Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.
- Exclusion Criteria: ● Abnormal presentation or occipito posterior position.
Show all 12Show fewer
- Multiple pregnancies.
- Cephalo-pelvic disproportion.
- Cervical surgery in the past or history of cervical injury.
- Patients on antihypertensive therapy.
- Known hypersensitivity to drotaverine or meperidine.
- If any other spasmolytic agent had been used within 48 hours.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Read the detailed description
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \& Gynecology
The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.
- Being tested
- Meperidine, Drotaverine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeperidineDrug
administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor
DrotaverineDrug
administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor
| Study group | Role | What they receive |
|---|---|---|
| meperidine and duration of 1st stage of labor | Experimental | meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor Receives: Drug: Meperidine |
| drotaverine and duration of 1st stage of labor | Experimental | drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor Receives: Drug: Drotaverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of the first stage of labor
the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor
Measured: 6 monthes
effect on the duration of the 1st stage of labor
the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor
Measured: 6 monthes
Secondary outcomes (1)
effect on pain
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term PrimigravidaeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236651
- Sponsor's protocol ID
- dr hegab protocol
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
- ClinicalTrials.gov ID
- NCT01236651
- Acronym / sponsor ID
- dr hegab protocol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 9 Nov 2010 (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.
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Detailed description
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \& Gynecology
The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meperidine and duration of 1st stage of labor | Experimental | Drug: Meperidinemeperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor |
| drotaverine and duration of 1st stage of labor | Experimental | Drug: Drotaverinedrotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Singleton pregnancy.
- Term gestation i.e, 38-41 weeks.
- Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
- Vertex presentation with occipito anterior position.
- Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Meperidineadminister 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor | Drug | meperidine and duration of 1st stage of labor |
| Drotaverineadminister 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor | Drug | drotaverine and duration of 1st stage of labor |
Primary outcome
the duration of the first stage of labor
Time frame: 6 monthes
the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor
effect on the duration of the 1st stage of labor
Time frame: 6 monthes
the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor
1 secondary outcome
effect on pain
Time frame: 6 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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 2 study testing Meperidine and Drotaverine in people with Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae, run by Ain Shams University at 1 site in Egypt.
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 12 inclusion and 0 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 9 Nov 2010. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mahmoud mohamed (0020106981179, hegab_2008@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of the first stage of labor (time frame: 6 monthes). The study lists 2 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 9 Nov 2010.