International Journal of Health and Pharmaceutical Sciences
ISSN 2278 - 0564 Vol 1, Issue 4, 2012 COMPARATIVE STUDY OF MICRONISED PROGESTERONE VERSUS ISOXSUPRINE IN THE PREVENTION OF PRETERM LABOUR 1Deepti S Shrivastava, 2*Shruti S Goel , 3Sunaina Arya
1Professor, 2,3Resident, Dept of Obstetrics & Gynaecology, JNMC Sawangi, Wardha (India). ABSTRACT: Introduction: Preterm labour is a major public health problem responsible for neonatal
morbidity and mortality,hence it is a time felt need to improve the outcome of preterm labor
and formulate better methods to prevent it. Aim : Compare the efficacy and safety of micronized
progesterone versus isoxsuprine in the prevention of preterm labor. Study design: Prospective
,interventional, case control comparative study of 200 women. Observations & Results: In the
study both the drugs were found equally effective in prevention of preterm labour along with
micronized progesterone offering a better safety profile. Prevention of preterm labour was equql
with both the drugs but sideeffects were significantly less with micronized progesterone i.e.
tachycardia ,headache ,palpitation and syncopal attacks were seen in 48%,61%,27%and 23% of
women with Isoxsuprine and only 12%, 21%,9% &7% women with micronized progesterone
respectively. Conclusion micronized progesterone is almost equally effective with fewer side
effects than isoxsuprine in prevention of preterm labour. KEY WORDS:
Preterm labour, micronized progesterone , Isoxsuprine . INTRODUCTION:
uterine contractions of sufficient strength
healthcare costs both in the developing and
dilatation and effacement of cervix between
delivery affects11% of pregnancies in US or
even greater in developing countries(23.3%
obstetric interventions, fetal survival is now
in India) .[2]It is rising world over because of
increased frequency of multiple births due to
best setup in developing countries, salvage
is rare below 28 weeks of gestation ,so it is
psychological stress and medically induced
better to arrest preterm labour till atleast 34
weeks of gestation to prevent complications
problem in terms of loss of life, long-term
• Women with gestational age between 28
patients at risk have been investigated, and
• Four uterine contractions in 20 minutes
• Cervical dilatation not more than 1 cm &
considered to be controversial but it is being
tried almost every where with a concern of
• History of previous preterm birth and
foetal lung maturity ,till atleast prophylactic
insufficiency and a cerclage in place. EXCLUSION CRITERIA:
used for tocolysis is isoxusuprine. In the
present study we have tried to compare its
micronized progesterone in various studies. MATERIALS AND METHOD:
Amongst the 200 women, GROUP A
intravaginally micronized progesterone 200
mg daily. Another group(B) of 100 women ,
injection isoxsuprine 10 mg intramuscularly
consent was taken from subjects recruited in
hours, later on switched over to 40 mg oral
retard capsules on mantainence therapy once
daily.Women with gestational age less than
gestational age were recruited. They were
intramuscularly that was repeated after an
RESULTS:
preterm labor and threatened preterm labor
viz., four uterine contractions in 20 minutes
women admitted with preterm labor at less
with or without cervical dilatation greater
than 37 weeks gestational age were recruited
than 1 cm or effacement 80% or greater. Table 1 shows the comparison of the
gestational ages amongst two groups.
belonged to the gestational age of 34 to 36
microscopy and vaginal swab was sent. INCLUSION CRITERIAL: Table 2 shows distribution of women
according to their parity.it was seen that
Table 4 shows better safety profile with
in group B were second gravida and both the
micronized progesterone as but side effects
Table 3 shows micronized progesterone was
,palpitation and syncopal attacks were seen
pregnancy to a period of more than 48 hours
isoxsuprine and only 12%, 21%, 9% &7%
was successful in prolonging for the same
progesterone the only annoying side effect
Table 1 shows estational age wise distribution of cases
Table 2 shows Parity wise distribution of the cases
ﭏ2-value
Table 3 depicts duration of prolongation achieved with the use of isoxusuprine and micronised
ﭏ2-value
Table 4 depicts the side effect profile of both the drugs in which micronized progesterone has a
better side effect profile as compared to isoxsuprine
DISCUSSION:
being born with a birth weight of less than
etiology of spontaneous preterm labor, only
identified.[1]Unfortunately, there is little
evidence confirming the effectiveness of any
of these strategies In particular, tocolysis of
associated with only small prolongation of
delivery (36.1 ± 2.66 vs. 34.0 ± 3.25 weeks,
P < 0.001). Micronized progesterone also
decrease perinatal mortality or morbidity.
had a protective role in preventing preterm
But it is still effective in threatened preterm
birth between 28 and 31 weeks plus 6 days.
labour and most commonly practised .
associated with a longer latency preceding
delivery. Progesterone group demonstrated a
progesterone in the body but identical.
Natural micronized progesterone is shown to
(36.1 ± 17.9 vs 24.5 ± 27.2) days. This
have fewer side effects and discomforts such
as headaches etc. than with the synthetic
than 48 hours t 1 week in 44% women.
labour concludes that tocolysis is definitely
efficacy of micronized progesterone with the
indicated before 34 weeks gestational age in
their study tocolysis delayed delivery in 39
both of them to be equally efficacious .On
offers better compliance profile as compared
group (19.2% vs. 34.4%; relative risk, 0.56;
95% confidence interval [CI], 0.36 to 0.86).
effectiveness of micronized progesterone as
administration of progesterone reduces the
isoxsuprine with advantage of lesser side
risk of preterm birth before 37 weeks and 34
almost nil contraindications for it.
Table 5: Showing different trials conducted demonstrating efficacy of micronised progesterone
Authors Progesterone Gestational No. of Subjects
Progesterone Placebo Progesterone Placebo
O Brien NMVBP gel 18 to 22 <35-22.7 <32 – 10.0 <28 – 3.2 NMVBP gel 33.9 <34 – 9.2 <37 – 695 NMVBP gel 35 <32 – 6.9 <27 - 8.0
management of preterm labor J Obstet
longer the first choice.the choice of tocolytic
outcome with no maternal or neonatal side
[3] Singh Uma, Singh Nisha, Seth ShikhaCONCLUSION:
outcome of preterm labor; J Obstet
preterm labour as it is equally efficacious
and has low side effect profile as compared
lesser side effects thereby it provides better
REFERENCES:
[1] Edwin Chandraharan, Sabaratnam
Arulkumaran; Recent advances in
J Obstet Gynecol 2010; 202:548.e1-8.
recurrent preterm labor: Journal of
[7] Rogelio Gonzalez et al: Prenatal adm. Reproductive Health Library; Geneva:
Brand Name (Generic Primary Use Ziagen® (Abacavir) ( Aripiprazole) Trisenox® (Arsenic Trioxide) To treat attention deficit problems CYP2D6 (Atomoxetine) Lipitor® ( Atorvastatin) To manage cholesterol. (Azathioprine) diseases of the immune system, post-organ transplant, Crohn’s disease, and ulcerative colitis. Victrelis® (Boceprevir) To treat hepatitis C i