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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

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

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]

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]

Mean injection-delivery interval, monitored by the author who was blind to the medication.

Timepoint [1]

from the time of beginning of the intervention to the time of the expulsion of the fetus.

Secondary outcome [1]

maternal adverse effects, monitored by the author who was blind to the medication.

Timepoint [1]

Monitored constantly throughout the birth after the allocated treatment has been injected into the participant.

Secondary outcome [2]

fetal adverse effects, monitored by the author who was blind to the medication.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Bulent Yilmaz

Address [1]

Taskent Sokak, 26/8, 06600, Kurtulus, Ankara

Country [1]

Turkey

Primary sponsor type

Individual

Name

Dr Sefa Kelekci

Address

Bassehir sokak, 14/8, 06150, Cebeci, Ankara

Country

Turkey

Secondary sponsor category [1]

Individual

Name [1]

Cavit Kart

Address [1]

Camlitepe mah., 2. Dedeefendi sokak, no: 76/9, 06600, Ankara

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research and Ethics Committee of the Zekai Tahir Burak Women's Health Education and Research Hospital

Ethics committee address [1]

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Painless and short labor without causing any adverse effects on the mother and fetus is desired by every pregnant women and a constant aim of active management for obstetricians. The progress of labor is assessed by progressive dilatation of cervix and progressive descent of the presenting part. Protraction of the first stage of labor, one of the components of prolonged labor, is multifactorial, and cervical dilatation is one of the important factors which determines the duration of the first stage of labor and is the end result of all driving forces of uterine contraction against passive tissue resistance. 
Failure of progressive dilatation of cervix in labor can cause prolonged labor. In addition to mechanical methods such as cervical membrane sweeping, cervical stretching, and amniotomy, there are various pharmacological methods to facilitate cervical dilatation. The role of oxytocin has been established worldwide in the inducing and augmentation of labor, and prostaglandins have been used in various formulations for induction of labor. Cervical application of hyaluronidase, estradiol and relaxin has also been used with some success. Various drugs such as phloroglucinol, tranquilizers, especially diazepam, opioids, especially meperidine, and antispasmodics such as valethamate bromide, drotaverine hydrochloride and hyosin-N-butyl bromide have been used for shortening the duration of labor.
Meperidine has been widely used for relief of labor pain and dystocia during the first stage of labor since its introduction in the late 1940s. Whereas analgesia is maximal about 30 to 45 minutes after an intramuscular (IM) injection, it develops almost immediately following intravenous administration. Meperidine readily crosses the placenta, and the half life is approximately 13 hours or longer in the newborn. Its depressant effect in the fetus follows closely behind the peak maternal analgesic effect. In the first randomized controlled trial to evaluate the use of meperidine as a way to shorten the duration of labor, meperidine was found the absent of any benefit on labor duration and presence of maternal adverse effects as well as other deleterious effects in the newborn.
Valethamate bromide is both a central and a peripheral antimuscarinic agent, which is a competitive inhibitor of acetylcholine at the muscarinic receptors. After IM administration, onset of action occurs in about 20–30 minutes. Plasma half-life is 4 hours. It crosses the placenta and is secreted in the breast milk. It is completely metabolized in the liver and is excreted in the urine as both unchanged drug and metabolites. Neurotropic and musculotropic actions of valethamate bromide result in relaxation of cervical musculature leading to quick dilatation of the cervix and shortened labor. 
The objective of this study was to compare the efficacy, safety and side effects of meperidine, valethamate bromide and placebo in shortening the duration of labor.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Bulent Yilmaz, MD

Address

Taskent Sokak, 26/8, 06600, Kurtulus, Ankara

Country

Turkey

Phone

+9005053574351

Fax

[email protected]

Contact person for scientific queries

Name

Bulent Yilmaz, MD

Address

Taskent Sokak, 26/8, 06600, Kurtulus, Ankara

Country

Turkey

Phone

+9005053574351

Fax

[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

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Documents added automatically

No additional documents have been identified.

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