Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000153213
Ethics application status
Approved
Date submitted
29/01/2009
Date registered
18/03/2009
Date last updated
18/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Meperidine versus valethamate bromide in shortening the duration of labor
Scientific title
Randomized prospective, double blind, placebo-controlled study to compare the efficacy and safety of meperidine and valethamate bromide with placebo for acceleration of labor.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shortening the duration of labor 4243 0
Condition category
Condition code
Reproductive Health and Childbirth 4465 4465 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 4675 4675 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 160 nulliparous term pregnant women undergoing labor induction were randomly assigned to one of three treatment groups using computer generated random number table: 50 mg meperidine in group 1 (n=53) and 16 mg valethamate bromide in group 2 (n=53) as the treatment groups. All medications were given just once time by slow intravenous infusion in about 2 minutes when cervical dilation was about 4-6 cm and the fetal head was well applying. Patient and the doctor who followed the stages of labor were blind to the medication.
Intervention code [1] 3967 0
Treatment: Drugs
Comparator / control treatment
Group 3 served as control group and consisted of 53 women who were given normal saline (0.9 % NaCl) as placebo. The medication was given just once time by slow intravenous infusion in about 2 minutes using injectors containing 10 mL solution (normal saline plus related group’s drug) when fetal head was well applying and uterine contractions were well-established, and cervical dilatation was between 4 and 6 cm. Patient and the doctor who followed the stages of labor were blind to the medication.
Control group
Placebo

Outcomes
Primary outcome [1] 5347 0
Mean injection-delivery interval, monitored by the author who was blind to the medication.
Timepoint [1] 5347 0
from the time of beginning of the intervention to the time of the expulsion of the fetus.
Secondary outcome [1] 8984 0
maternal adverse effects, monitored by the author who was blind to the medication.
Timepoint [1] 8984 0
Monitored constantly throughout the birth after the allocated treatment has been injected into the participant.
Secondary outcome [2] 8985 0
fetal adverse effects, monitored by the author who was blind to the medication.
Timepoint [2] 8985 0
Immediately after delivery .

Eligibility
Key inclusion criteria
otherwise healthy nulliparous women undergoing labor induction between 18 and 30 years old with a term singleton pregnancy, vertex presentation
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
spontaneous labor, estimated fetal weight > 4000 g, suspicion of cephalopelvic disproportion (CPD), evidence of fetal distress, meperidine or valethamate bromide allergy, previous uterine surgery, active vaginal bleeding, placenta praevia, and use of any kind of analgesia prior randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation was predetermined and placed in consecutively numbered opaque, sealed envelopes. The next consecutive envelope was drawn after the patient consented to randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was performed with use of a computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment outside Australia
Country [1] 1550 0
Turkey
State/province [1] 1550 0

Funding & Sponsors
Funding source category [1] 4425 0
Self funded/Unfunded
Name [1] 4425 0
Dr Bulent Yilmaz
Country [1] 4425 0
Turkey
Primary sponsor type
Individual
Name
Dr Sefa Kelekci
Address
Bassehir sokak, 14/8, 06150, Cebeci, Ankara
Country
Turkey
Secondary sponsor category [1] 4228 0
Individual
Name [1] 4228 0
Cavit Kart
Address [1] 4228 0
Camlitepe mah., 2. Dedeefendi sokak, no: 76/9, 06600, Ankara
Country [1] 4228 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6474 0
Human Research and Ethics Committee of the Zekai Tahir Burak Women's Health Education and Research Hospital
Ethics committee address [1] 6474 0
Ethics committee country [1] 6474 0
Turkey
Date submitted for ethics approval [1] 6474 0
Approval date [1] 6474 0
Ethics approval number [1] 6474 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29225 0
Address 29225 0
Country 29225 0
Phone 29225 0
Fax 29225 0
Email 29225 0
Contact person for public queries
Name 12472 0
Bulent Yilmaz, MD
Address 12472 0
Taskent Sokak, 26/8, 06600, Kurtulus, Ankara
Country 12472 0
Turkey
Phone 12472 0
+9005053574351
Fax 12472 0
Email 12472 0
[email protected]
Contact person for scientific queries
Name 3400 0
Bulent Yilmaz, MD
Address 3400 0
Taskent Sokak, 26/8, 06600, Kurtulus, Ankara
Country 3400 0
Turkey
Phone 3400 0
+9005053574351
Fax 3400 0
Email 3400 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.