Dissertation presentation

EFFECT OF HYOSCINE N-BUTYL BROMIDE ON DURATION OF LABOUR IN TERM PREGNANCIES INNORTH OKKALAPA GENERAL HOSPITAL : 

EFFECT OF HYOSCINE N-BUTYL BROMIDE ON DURATION OF LABOUR IN TERM PREGNANCIES INNORTH OKKALAPA GENERAL HOSPITAL A Dissertation Submitted for The Degree of Master of Medical Science (M.Med.,Sc) (Obstetrics and Gynaecology) University of Medicine (2), Yangon   MYA KYAR PHYU 2010

AIM AND OBJECTIVES : 

AIM AND OBJECTIVES Aim To study the effect of hyoscine N-butyl bromide on duration of labour in term pregnancies in North Okkalapa General Hospital.

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Objectives To compare the duration of labour in term pregnancies with or without hyoscine butyl bromide To study the effects of hyoscine butyl bromide on mother and fetus.

MATERIALS AND METHODS : 

MATERIALS AND METHODS Study design Hospital-based randomized controlled clinical study Study site Labour ward complex, maternity unit, NOGH. Study period 1st October, 2008 to 30th September, 2009 Study population A total of 133 women (according to inclusion criteria)

Methodology : 

Methodology Out of 133 women, 60 women (Drug group) were given 40 mg hyoscine butylbromide as a slow intravenous injection in the active phase of labour (os – 3 or 4 cm). 73 women received no drug (Control group). 4 cases of control group were excluded due to delivery by Caesarean section.

Table (1) Background characteristics : 

Table (1) Background characteristics

Figure (5.2) Age distribution of patients in two groups : 

Figure (5.2) Age distribution of patients in two groups

Figure (3) Comparison of gravida in two groups : 

Figure (3) Comparison of gravida in two groups

Table (5.2) Comparison of duration of first stage by parity: hyoscine N-butyl bromide group Vs control groups : 

Table (5.2) Comparison of duration of first stage by parity: hyoscine N-butyl bromide group Vs control groups

Table (5.3) Comparison of Rate of cervical dilatation (cm/hr) in hyoscine group versus control groups : 

Table (5.3) Comparison of Rate of cervical dilatation (cm/hr) in hyoscine group versus control groups

Table (5.4) Comparison of duration of second stage (minutes) in hyoscine group versus control group : 

Table (5.4) Comparison of duration of second stage (minutes) in hyoscine group versus control group

Table (5.5) Comparison of duration of 3rd stage (minutes) in hyoscine group versus control group : 

Table (5.5) Comparison of duration of 3rd stage (minutes) in hyoscine group versus control group

Table (5.6) Comparison of necessity of augmentation with syntocinon in hyoscine group versus control group : 

Table (5.6) Comparison of necessity of augmentation with syntocinon in hyoscine group versus control group

Table (5.7) APGAR score at 5 and 10 minutes : 

Table (5.7) APGAR score at 5 and 10 minutes

Table (5.8) Comparison of mode of delivery in hyoscine group versus control group : 

Table (5.8) Comparison of mode of delivery in hyoscine group versus control group

Table (5.9) Comparison of maternal side effects in hyoscine group versus control group : 

Table (5.9) Comparison of maternal side effects in hyoscine group versus control group

DISCUSSION : 

DISCUSSION The process of labour puts great strain on the mother and her fetus. It is clear that the perinatal loss rate mounts rapidly when the first stage of labour exceeds 20 hour and the second stage 2 hour. Acceleration of labour to shorten its duration without jeopardizing the maternal and fetal condition would therefore minimize the maternal and fetal morbidity and mortality.

Background characteristics : 

Background characteristics There were no statistical differences among two groups in terms of age, gravida, parity and gestational age. The same as other studies.

Duration of first stage of labour : 

Duration of first stage of labour Without syntocinon, the mean duration of 1st stage of labour in nulliparas drug group - 250.0  19.8 minutes in control group - 331.0  24.6 minutes (p=0.014)

Duration of first stage of labour : 

Duration of first stage of labour Without syntocinon, the mean duration of 1st stage of labour in multiparas drug group - 157.5  17.5 minutes control group - 205.8  28.3 minutes (p=0.134). Without syntocinon, a significant reduction in the duration of the first stage of labour in nulliparas no significant reduction in multiparas when compared with the control group.

Explanation : 

Explanation more common association of cervical dystocia and nulliparas hyoscine butylbromide released the effect of cervical dystocia (cervical spasmolytic action). Whereas in multiparas, cervical dystocia was not commonly found hyoscine effect on cervix of multiparas was not so pronounced as in cervix of nulliparas.

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The results - the same as other studies in overall dilatation with or without syntocinon. Other studies did not compare the pure effect of hyoscine butylbromide on both nulliparas and multiparas. The present study compared the pure effect of the drug on the cervix, thereby noticeably showing the effect on nulliparas’ cervix and duration of first stage was shortened only in nulliparas. It is different from other studies.

Rate of cervical dilatation : 

Rate of cervical dilatation The mean rate of cervical dilatation in nulliparas (drug group) without syntocinon was 1.8  0.2 cm/h and those in control group was 1.3  0.1 cm/h. There was a statistical significant difference in rate of cervical dilatation in nulliparas without syntocinon (p=0.016).

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The mean rate of cervical dilatation in multiparas (drug group) was 3.2  0.4 cm/h and those in control group was 2.2  0.3 cm/h. There was no statistical significant difference in both groups (p=0.058). So, hyoscine N-butyl bromide causes a rapid cervical dilatation only in nulliparas and not in multiparas. Other studies did not compare the rate of cervical dilatation without syntocinon.

Duration of second stage : 

Duration of second stage Without syntocinon, the mean duration of the second stage in nulliparas (drug group) was 19.8±4.1 minutes and that in the control group was 28.0±4.0 minutes (p=0.170). Also in the multiparas (drug group), the mean duration of the second stage was 13.7  2.9 minutes whereas in the control group, it was 13.1  3.7 minutes (p=0.907).

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They were not statistically significant. Thus, hyoscine N-butyl bromide cannot shorten the duration of second stage of labour in both nulliparas and multiparas. This result was the same as other studies.

Duration of third stage : 

Duration of third stage Without syntocinon, the duration of third stage in nulliparas (drug group) was 5.7±0.6 minutes and that in control group was 7.1±0.5 minutes (p=0.105). The duration of third stage in multiparas (drug group) without syntocinon was 5.5±0.7 minutes and that in control group was 6.5±0.6 minutes (p=0.188). So, this study observed that duration of third stage was no statistical difference in drug and control group as compared to other studies.

Augmentation with syntocinon : 

Augmentation with syntocinon the risk of requiring augmentation among control group is about 3 times significantly higher than those in drug group (p = 0.006, OR = 2.69; 95% CI 1.3 – 5.5).

Apgar scores at 5 and 10 minutes : 

Apgar scores at 5 and 10 minutes the mean APGAR scores in drug group at 5 minutes was 8.4±0.08 and at 10 minutes was 9.4±0.08 (p=0.051). In control group, the mean APGAR scores at 5 minutes was 8.2±0.09 and at 10 minutes was 9.2±0.09 respectively (p=0.070). There was no statistical difference in Apgar scores in both groups.

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no clinically significant effects on the neonate in any of the major organ systems. Although the study was not sufficiently powered for the absolute exclusion of fetal/neonatal adverse effects, the initial examination of each infant, on which the Apgar scores were based, showed no discernible difference in the infants of the drug group compared with the control group. Since the sample size is small and period of study short, long term neurodevelopmental outcomes may not surfaced, which may be better evaluated in larger well designed double blind control studies.

Mode of delivery : 

Mode of delivery 3 cases in drug group and 8 cases in control group needed instrumental delivery (p=0.107). 4 cases of control group were excluded due to delivery by Caesarean section. The indications of Caesarean section are cervical dystocia in 3 cases and fetal distress in 1 case. So, there is no difference in mode of delivery. This study showed results regarding about mode of delivery are similar to other studies.

Maternal side effects : 

Maternal side effects In this study, 1 case from drug group and 1 case from control group got PPH. The case from drug group occurred in gravida 2, birth weight was 4000 g and duration of first stage of labour was 90 minutes. This may be due to uterine atony due to big baby and precipitated labour may be included. This PPH was not severe and can be controlled by oxytocics alone and no need for blood transfusion.

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The case from control group occurred in gravida 4, birth weight was 3800 g and duration of first stage of labour was also 90 minutes. This may be due to uterine atony due to multiparity, big baby and precipitated labour effect may be included. It was not also severe and can be controlled with drug only. Therefore, the blood losses were comparable in both groups and no significant maternal side effects in drug group.

CONCLUSION : 

CONCLUSION Every woman in reproductive age can face with stress and dangers of prolonged labour in her life. It is not only concerned with parturients but also with obstetricians. It also makes a hazardous journey for the fetus. So, O’Driscoll et.al introduced active management of labour.

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Although methods to increase uterine contractility such as amniotomy and use of oxytocics have been shown to shorten the duration of labour, yet these methods are not without complications. This study showed one of the safest method for shortening the duration of labour.

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Hyoscine N-butylbromide, one of antispasmolytic drugs, available abundantly in Myanmar can shorten the duration of labour and it was tested and proved in other hospitals outside Myanmar. Like other studies, this study can prove that duration of first stage of labour was significantly shortened in nulliparas, avoiding the maternal and fetal risks of prolonged labour.

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There was no significant change noted in the time for the second and third stage of labour. There was also no difference in the associated blood loss or of the Apgar scores noted at 5 and 10 minutes, respectively. No adverse events or significant adverse effects were noted in the group of women receiving receiving hyoscine butylbromide, compared with the control group. No difference was noted in mode of delivery. The risk of requiring augmentation among control group is about 3 times significantly higher than those in drug group.

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Based on the results of this study, and noting the supportive data from similar clinical trials, we concluded that hyoscine butylbromide is effective in significantly reducing the duration of the first stage in nulliparas it is not associated with any obvious adverse outcomes in mother or neonate. Further long-term evaluation will be necessary to fully evaluate the scope of benefits that this reduction may confer.

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