A NON-RANDOMISED CONTROLLED TRIAL STUDY BETWEEN NIFEDIPINE AND ISOXSUPRINE AS TOCOLYTICS FOR PRE-TERM LABOUR.

Corresponding Author:
Dr. Manas Kumar Saha,
Ujjwala Bhawan,
Flat No. 3C/1,
Gorekhara,
Ghoshpara, Kolkata-150,
West Bengal, India.
E-mail: drmanas.saha@gmail.com

ABSTRACT

BACKGROUND

Preterm labour and delivery are one of the biggest challenges for obstetricians, as they show increasing trends in the countries where data is available. Preterm labour and delivery remain a major cause of perinatal morbidity and mortality. Preterm delivery affects 11% in US^[1] or even greater in developing countries (23.3% in India)^[2] and it accounts for 40 - 75% of neonatal deaths. Prediction and prevention of preterm labour is not possible despite extensive research on the subject. So, we have to face preterm labour and manage our patients according to their gestational age. So, our aim in the management of preterm labour is to arrest the labour process at least for 48 hrs. to obtain the lung maturity by inj. Betamethasone. By these we can at least reduce the risk of respiratory distress syndrome, but could not exempt the baby from other complications of prematurity. Numerous drugs and interventions have been used to prevent and inhibit preterm labour, but none have been found to be completely effective with the choice being further limited by troublesome side effects. The tocolytic agents which are frequently used in obstetric practice are β-adrenergic receptor blocking agent like isoxsuprine hydrochloride and calcium channel blocker like nifedipine are two commonly used tocolytic agents in India.

The aim of this observational cross-sectional study is to assess the most effective tocolytic agent between nifedipine and isoxsuprine for prevention of preterm labour.

MATERIALS AND METHODS

This is a non-randomised controlled trial study done in Calcutta National Medical College and Hospital, Kolkata, G and O Department. This study was done during the period between January 2016 and December 2017.

RESULTS

A study was done on 50 cases of Pre-Term Labour (PTL) between 28 - 36 weeks: Group A (25 cases) were treated with oral Nifedipine and Group B (25 cases) were treated with parenteral followed by oral Isoxsuprine. Descriptive statistical methods were used for outcome analysis. Outcomes including gestational age at delivery, prolongation of pregnancy, maternal and foetal side effects were noted and analysed. Majority of patients were in the younger age group around 33 - 35 weeks of gestation. Majority of patients among this age group were primigravidae. In our study, use of nifedipine leads to prolongation of pregnancy around 4 weeks and delivery occurred around 37 weeks with good foetal outcome. In few cases, drugs were withdrawn due to some side effects.

CONCLUSION

There is a high incidence of preterm labour in India. Nifedipine is a better tocolytic drug than isoxsuprine hydrochloride, especially when started with the earliest signs of preterm labour.

KEY WORDS

Pre-Term Labour (PTL), Tocolytic Drugs, Betamethasone, Nifedipine, Isoxsuprine Hydrochloride.