1. EFFICACY AND SAFETY OF ORAL MICRONIZED PROGESTERONE FOR PREVENTION OF PRETERM BIRTH
Win Nanda Myo, Khin May Htwe, San San Myint
Department of Obstetrics and Gynaecology
University of Medicine (1),
Yangon, Myanmar

2. INTRODUCTION

3. Preterm labour is a major clinical problem
a leading cause of neonatal mortality and morbidity with long term neurodevelopmental sequelae
Early detection and prevention of preterm birth is important
Acute tocolytic treatment provides time for corticosteroid action and in utero transfer
Different drugs are used for maintenance tocolysis to prevent the recurrent preterm birth after arrested preterm labour

4. Progesterone (uterine sedative drug) to prevent the recurrent preterm birth and prolong the pregnancy
The Aim of this study - to detect the efficacy and safety of oral micronized progesterone(OMP) for prevention of preterm birth
hospital-based cross-sectional descriptive study
carried out in Central Women’s Hospital, Yangon (from 1st January 2015 to 31st December 2015).

5. MATREIALS AND METHODS

6. Study population Exclusion Criteria
Sixty Singleton pregnant women after successful tocolysis with nifedipine therapy at gestation of 24 - < 34 weeks
Exclusion Criteria
Multiple pregnancies
Premature rupture of membranes
Antepartum haemorrhage
Fetal growth restriction
Fetal distress
Fetal congenital abnormalies

7. STUDY PROCEDURE
All patients involved in this study- were given acute tocolytic treatment according to hospital gudelines
After the arrest of preterm labour, patients were recruited for this study within 12 hours after completion of acute tocolytic treatment
Informed written consent was taken from eligible women
Detailed history taking and examination (general physical examination, obstetrics examination and speculum examination)
Routine obstetric investigations and special investigation

8. patient was given 200 mg of OMP daily upto 37 weeks by weekly or till delivery
called follow up at antenatal visit weekly
looked for signs and symptoms of preterm labour, side effects of drug and compliance in taking medication were checked.
Outcome parameters such as latency period, maternal side effects, fetal parameters were assessed

9. RESULTS

10. Table (1) Background characteristics of the study population
Study (N=60)
Age
26.20 ± 5.31
Gravida
± 1.01
Parity
± 0.78
History of preterm Labour
6 (10%)
Presence of any risk factors
10 (16.7%)
Mean Gestational age at entry (weeks)
32.18 ± 2.18

11. Table (2) Frequency distribution of gestational age at delivery
Characteristics
Study(N=60)
Mean Gestational age at delivery
37.11±1.32
28-31⁺⁶
32-33⁺⁶
1(1.7%)
34-36⁺⁶
15(25%)
≥37
44(73.3%)

12. Table (3) Frequency distribution of treatment delivery interval (Latency period) of the study population
Characteristics
Study(N=60)
Mean latency period
4.93 ± 2.43
1-2 wks
6(10%)
3-4 wks
26(43.3%)
5-6 wks
15(25%)
7-8 wks
7(11.7%)
9-10 wks
4(6.7%)
11-12 wks
2(3.3%)

13. Table(4)Maternal side effects among the study populations
Study(N=60)
Drowsiness and dizziness
6(10%)
Headache
2(3.3%)
Acne
0(0)
Oesophageal reflux
7(11.7%)
Breast tenderness
5(8.3%)

14. Table(5) Fetal outcomes among study population
Characteristics
Study(N=60)
Mean birth weight of Babies
2.87±0.37
≥ 2.5 kg
55(91.7%)
< kg
5(8.3%)
Apgar score ≥7 at 5 mins
56(93.3%)
Apgar score < 7 at 5 mins
4(6.7%)
NICU admission for prematurity
1(20%)
NICU admission for LBW
2(40%)
NICU admission for Jaundice
Early Neonatal death

15. DISCUSSION

16. Mean maternal age of the studied population was 26. 20 years ± 5.31
Mean garvida of this study was 1.57 ± 1.01
in the study of Choudhary, parity was no significant differences in study group and placebo group (Choudhary et al, 2014).
In this study, two third of preterm labour patients were primigravidae and one third were mulitigravidae.

17. Previous preterm delivery -10% previous preterm labour in the present study
Choudhary et al(2014), 13% of cases in OMP group and only 4% of cases in placebo group
mean gestational age at entry to the study was weeks with standard deviation 2.18
Choudhary et al(2014), weeks ± 2.00 in OMP group and weeks ± 1.65 in placebo group
Choudhary et al study- more or less similar to the present study

18. mean gestational age at delivery was 37.1 weeks ± 1.32
Choudhary et al (2014)- mean gestational age at delivery-36.8 wks ± 2.64 in OMP and 35.9 wks ± 2 in placebo group
1 week longer in this study than Choudhary study
No preterm delivery in between 28 and <32 weeks
16 patients (26.7%) in total 60 patients delivered between 32 - <37 weeks
44 patients (73.3%) of total 60 delivered at 37 weeks or later
Choundary et al study, 28 patients (62%) in OMP group and 16 patients (36%) in the placebo group delivered at ≥37 weeks

19. Mean latency period in this study - 4.93 weeks ± 2.43
findings were similar with Choundary’s OMP group findings.
Choundary et al- mean latency period was 4.76 weeks ± 3.16 in OMP group and weeks ± 2.20 in placebo group (p=0.01)
the most common side effects was oesophageal reflux in 7 cases (11.7%)
mean birth weight of babies kg ± 0.37
majority of babies - 55 babies (91.7%) had birth weight ≥ 2.5 kg
only 5 babies (8.3%) - < 2.5 kg.
In Regmi (2012) -mean birth weight in 17-hydroxyprogesterone group was kg ± 0.59 and in control group was 2.78 kg ± 0.44.
Similar with Regmi OMP group

20. Majority of babies had Apgar score 7 or more
only 4 cases had Apgar score <7 at 5 mins
Choudhary et al - no significant differences in between the study and the control group for Apgar score
Choudhary et al - 10 cases in OMP group required admission to Neonatal Intensive Care Unit compared to 9 cases in control group
No statistically significant differences
In this study, only 5 cases (8.3%) were admitted to NCIU
2 out of 5 babies were admitted for < 1week and 3 out of 5 were admitted for >1week.
 one prematurity case, two neonatal jaundice and two low birth weight babies were admitted to NCIU.

21. CONCLUSION

22. Mean (SD) treatment delivery interval was 4.93 ± 2.43 weeks
Mean (SD) gestational age of delivery was ± 1.32weeks
Preterm births occurred only twenty six percent of cases in this study
Current study demonstrated that safety of OMP as tocolytics
Some patients had minor side effects such as headache, drowsiness ad dizziness, oesophageal reflux and breast tenderness which are tolerable and negligible

23. Mean birth weight of babies was 2.8 kg ± 0.37
Majority of babies had good Apgar score
The Apgar score <7 at 5 mins were only 6.7%
Only 5 cases (8.3%) of the studied population required admission to NICU
There was no early neonatal death in newborn babies of the studied population

24. According to the study results-
maintenance tocolysis with OMP significantly prolonged pregnancy and decreased preterm births with tolerable minor side effects
Regarding to the neonatal outcomes-
not describe the significant improvement in neonatal outcomes
no significant adverse neonatal outcomes

25. In conclusion
maintenance tocolysis with OMP significantly prolonged pregnancy
decreased the numbers of preterm births
The present results support the use of OMP as a maintenance tocolytic for prolongation of pregnancy in case of arrested preterm labour.

26. Further studies are needed
the study was a descriptive study only
not a randomised study and small sample size
did not have sufficient power to demonstrate significant neonatal outcomes
To account for this, further studies with larger samples size with comparative double blind randomized studies are needed

27. REFERENCES

28. Choudhary M, Suneja A, Vaid NB, Guleria K and Faridi MMA (2014)
Choudhary M, Suneja A, Vaid NB, Guleria K and Faridi MMA (2014). Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labour. International journal of Gynaecology and Obstetrics; 126 (1):
Johnson JW, Austin KL and Jones GS (1975). Efficacy of 17alpha- hydroxyprogesterone caproate in the prevention of premature labor. N Engl J Med; 293:675–680.

29. Regmi MC, Rijal P, Agrawal A and Uprety D (2012)
Regmi MC, Rijal P, Agrawal A and Uprety D (2012).Progesterone for prevention of recurrent preterm labour after arrested preterm labour. A Randomised Controlled Trial.Gynaecol Obstet; 2: 125.
Sandar-Myint (2003).Prediction of spontaneous preterm delivery by ultrasonographic measurement of cervical length. A dissertation for the degree of M.Med.Sc (O & G).University of Medicine (1), Yangon.

30. THANK YOU