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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE
KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
6.
Brief resume of the intended work
6.1 Need for the study:
Labour is a multifactorial process which involves myometrial contraction;
cervical ripening and dilatation and the expulsion of the fetus and placenta in an
orderly manner. The first stage of labour in a primigravida lasts about 12 – 16
hours and in a parous woman 6 – 8 hours.
Prolonged labour has been a dreaded problem for obstetricians. The most
common cause of prolonged first stage of labour is cervical spasm leading to
cervical dystocia. Many times it is observed that inspite of good uterine
contractions, cervix fails to dilate or dilates very slowly. This is functional cervical
dystocia. Methods that aim at minimizing the incidence of functional cervical
dystocia and cutting short the first stage of labour are welcome by both
obstetricians and women.
The aim of active management of labour is a reduction in the total duration of
labour without causing any adverse effects on the mother or fetus.
Many spasmolytic drugs have been used and tried in the past, Drotaverine is
a newer Spasmolytic drug acts by inhibiting phosphodiesterase enzyme IV, which
is claimed to reduce the duration of labour by accelerating cervical dilatation
without causing side effects.
Epidosin (valethamate bromide) is also an antispasmodic which helps in
cervical dilatation due to its neurotropic or atropine like action and musculotropic
or papaverine like action.
6.2 Review of Literature :
The study was conducted to know the effect of drotaverine for
acceleration of labour and relief of labour pains. The study was done by doubleblind placebo-controlled randomized study, 100 primigravidae in uncomplicated
spontaneous labour at term were given drotaverine hydrochloride or placebo
(distilled water) intramuscularly. Labour events, including pain, neonatal outcome,
and side effects of the drug were recorded. Student’s t-test was used for analysis.
In drotaverine group, there was a mean 15% reduction in the duration of the first
stage of labour and a mean 19% reduction in the second stage. They concluded
that the drotaverine hydrochloride is safe and effective in accelerating labour, but
not effective in lessening labour pain.1
The study was conducted to compare the efficacy of drotaverine and
epidosin in shortening the duration of first stage of labour. Three hundred
demographically similar women with full term pregnancy in active labour were
included in the study and divided in two groups viz. drotaverine group (N=250)
given drotaverine intramuscularly at 3-4cm dilatation two hourly and epidosin
group (N=50) were given epidosin intramuscularly at 3 – 4 cm dilatation one
hourly. Comparative analysis was carried out as regards duration of various stages
of labour, rate of cervical dilatation, side effects and fetomaternal outcome.
Duration of active phase of first stage was 116.34  59.44 and 158.78  58.98
minutes in group I and II respectively. Rate of cervical dilatation was 3.99  2.21
and 2.74  1.72 cm/hour in group I and II respectively. They observed drotaverine
to be a better drug for cervical dilatation than epidosin.2
The study was conducted to know the effect of drotaverine and valethamate
bromide on the duration of labour. A randomized prospective study was carried
out on 300 women in normal labour. The results were the mean duration of first
stage of labour was 132.67  60.24 minutes in the epidosin group, 175.92  90.56
minutes in the drotaverine group and 287.68  104.1 minutes in the control group.
They concluded that both epidosin and drotaverine were highly effective; epidosin
was better in multipara in shortening the duration of labour.3
The study was designed to evaluate the effect of drotavaerine on cervical
dilatation, and compare its efficacy with epidosin. The study was carried out on
150 patients which included both primigravidae and multigravidae who were at
term in the early active phase of labour. The average rate of cervical dilatation in
primigravidae with inj. drotin, an isoquinoline derivative was 2.05 cm/hour and
with inj. epidosin 1.53 cm/hour. In multigravidae it was 3.68 cm/hour and 2.00
cm/hour respectively. The average time taken from 3cm to full dilatation of cervix
was 3 hours 25 minutes with drotaverine and 4 hours 35 minutes with epidosin in
primis and 1 hour 45 minutes and 3 hours 30 minutes in multis.4
The study was conducted to compare the efficacy and safety of drotaverine
hydrochloride and valethamate bromide in shortening the duration of labour. The
study was done by randomized controlled trial of 150 nulliparous women in
established labour with cervical dilatation of 4cm, 50 women were given
drotaverine (group I), 50 women were given valethamate (group II) and another
50 women were not given any medication (group III). Duration of labor, mode of
delivery, side effects and neonatal outcome were measured in all cases.
Appropriate non-parametric tests and x2 tests were used for assessment of
statistical significance. They observed that the injection to delivery interval was
significantly reduced in the drotaverine group (193.96 min) in contrast to the
valethamate group (220.68 min) and control group (412.84 min). The rate of
cervical dilatation was highest in the drotaverine group (2.04 cm / hour) compared
with the valethamate bromide group (1.86 cm/hour) and control group (1.01 cm /
hour). They concluded that both intramuscular drotaverine hydrochloride and
valethamate bromide are effective in acceleration of labor; however drotaverine
accelerates labour more rapidly and is associated with less side effects.5
The study was conducted to know the effect of intramuscularly
administered drotaverine on the dilatation stage of uncomplicated deliveries. They
observed that drotaverine shortens the dilatation stage of labour by 53 minutes
(mean 183.6  121.1 minutes) as compared to control group. Duration of II and III
stage were not prolonged.6
6.3 Objectives of the study:
To compare the efficacy of drotaverine and epidosin in shortening the
duration of first stage of labour.
7.
Materials and methods:
7.1 Source of data:
The source of data will be patients attending the teaching hospital attached to
J.J.M. Medical College, Davangere namely,
 Bapuji Hospital, Davangere.
 Chigateri General Hospital, Davangere.
 Women and Children Hospital, Davangere.
7.2 Method of collection of data (including sampling procedure if any).
A total of 150 patients attending the teaching hospital attached to J.J.M.
Medical College, Davangere, will be selected by convenient sampling method.
Inclusion criteria :
Women having normal singleton pregnancy at 38 – 41 weeks gestation,
with vertex presentation, intact membranes and spontaneous onset of labor
included in the study.
Exclusion criteria :
Patients with  Previous uterine scar.
 Cephalopelvic disproportion.
 Grand multiparity.
 Antepartum haemorrhage.
 Twin pregnancy.
 Preterm labour.
PROCEDURE OF STUDY :
In the present study, 50 patients will be alloted in each of the study groups.
Group I : Included cases where none of the cervical dilatation drug administered
during labour.
Group II : Cases where injection epidosin during labour administered at an interval
of 30min – 1hour upto a maximum of 6 injections.
Group III : Cases where inj. drotaverine administered iv during labour at an
interval of 2 hours upto a maximum of 3 injections.
The patients will be monitored for pulse rate, blood pressure, uterine
contractions, progress and descent of presenting part, cervical dilatation and fetal
heart sound.
Maternal side effects like tachycardia, fever, flushing of skin, dryness of
mouth, nausea, vomiting will be recorded. Mode of delivery, duration of I, II, III
stage of labour and fetal outcomes will be recorded and compared to know the
efficacy of drotaverine and epidosin on cervical dilatation and in shortening the
duration of first stage of labour.
7.3 Does the study require any investigations or interventions to be conducted
on patients or other humans or animals? If so, please describe briefly:
Yes
The study requires routine investigations like,
 Hb%
 Urine, albumin, sugar, microscopy.
 HIV
 HBSAg
 Blood grouping and Rh typing.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8.
LIST OF REFERENCES:
1. Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for
augmentation of labor. Int J Gynecol Obstet January 2004;84(1):17-22.
2. Devinder K, Ravinder K. Comparison of drotaverine and epidosin in first stage
of labor. J Obstet Gynecol India September / October 2003;53(5):449-52.
3. Khosla AH, Bala I, Dahiya K, Sangwan K. A comparative study of the efficacy
of valethamate bromide with drotaverine in normal labor. J Obstet Gynecol
India November / December 2003;53(6):568-70.
4. Mishra SL, Toshniwal A, Runoobanerjee. Effect of drotaverine on cervical
dilatation : A comparative study with epidosin (valethamate bromide). J Obstet
Gynecol India May-June 2002;52(3):76-9.
5. Sharma JB, Pundir P, Kumar A, Murthy NS. Drotaverine hydrochloride VS.
valethamate bromide in acceleration of labour. Int J Gynaecol Obstet Sep
2001;74(3):255-60.
6. Demeter J, Blasko S. The effect of intramuscularly administered drotaverine
on the dilatation stage of uncomplicated deliveries. Obstet Gynecol
1998;3:723-37.