Evaluation of per Vaginal Bleeding With Different Drugs in Successful Pregnancy in Patients With Recurrent Pregnancy Loss: An Original Research.

Introduction: One of the hormones that are crucial in safe pregnancy is the Progesterone. Its defect may cause bleeding and abortion. Hence, in this study, we evaluated two different drug modalities of progesterone for their efficacy. Material and
Methods: We piloted a prospective observational study among 100 pregnant women in their first trimester. They were divided to two equal groups to receive oral dydrogesterone and vaginal progesterone. The clinical and the demographic data with detailed history were taken and noted. The patients were followed up till the pervaginal bleeding stopped and till second trimester end. The comparisons were made between the groups using Chi square test deliberating P < 0.05 as significant.
Results: The age, BMI, and the progesterone levels were comparable between the groups. No significant difference between the groups was seen for the adverse reactions and for the continuation of pregnancy till 24 weeks. However, there was a significant variation in the cessation of the pervaginal bleeding, with lower time for the oral dydrogesterone.
Conclusion: Compared to the vaginal progesterone, oral dydrogesterone performed better in preventing the pervaginal bleeding and prolonging the viability of the pregnancy till the second trimester end. Copyright:

INTRODUCTION

The hormone progesterone is vital in the fertility of the women. It is essential to maintain the viability of the pregnancy. The derailment in this hormone secretion is associated with an increased rate of the pervaginal bleeding and ultimately the higher risk of the abortion in the first trimester.[12] The progesterone is essential for the maintenance of the pregnancy till the fetus turns viable. Previous studies have shown that among the women with greater number of the miscarriages, the level of the progesterone is lower than those with no abortions. This lower proportion of the progesterone was more evident in the first trimester at the initial stages of the pregnancy.[345] Pervaginal bleeding is the first sign seen in the threatened abortion. The mental trauma that a woman has to endure after an abortion is immense. There are many factors that may lead to the abortion, the most common being the chromosomal abnormality and thyroid deficiencies.[567]

Although there are many studies concluding the significance of the progesterone in preventing the miscarriages, the studies that analyze the route of the administration of this hormone are debatable. Hence, in this study, we evaluated two different drug modalities of progesterone for their efficacy.

MATERIALS AND METHODS

We piloted a prospective observational study among 100 pregnant women in their first trimester and had a pervaginal bleeding. The ethical clearance was obtained for the study. The study was explained to the spouses as well as the patients and the written consent was taken. The age-matched women who had a history of abortions and no other medical conditions and were 12 weeks pregnant were included in the study. We excluded the patients who were diabetic or had any other medical conditions that interfere with the study outcomes. The patients were divided to two groups of 50 each and were administered oral dydrogesterone once in a day (30 mg OD) and vaginal progesterone (600 mg OD). The demographics, detailed history, and the clinical data were noted. The patients were followed up till the end of 2nd trimester/24 weeks and till the delivery. Data collected were analyzed using the IBM SPAA ver 20. Comparisons were made applying the Chi square test deliberating P < 0.05 as significant.

RESULTS

We observed that among the groups there was no significant variation for the age groups, BMI, or the progesterone levels. There was significant difference for the viability of the pregnancy between the groups till the end of the second trimester or the 24 weeks. However, there was a significant variation for the time for complete stoppage of bleeding between the groups with the lower time required for the dydrogesterone (30 mg OD) compared to the vaginal progesterone (600 mg OD). When the adverse reactions were compared, there was no significant variation between the two groups, the most common being the Nausea, vomiting, and abdominal cramps, and headache and fatigue were seen in less than 10% of the patients. The vaginal irritation was seen exclusively among the vaginal progesterone group [Table 1].

Table 1

Various parameters comparison among the groups

Parameters	Oral	Vaginal	P
Age	25.51±3.01	26.11±1.52	0.0804
BMI (kg/m2)	22±3.02	23±2.8	0.3889
Progesterone levels (ng/mL)	19.21±7.05	21.22±8.12	0.1566
Continuation till second trimester
History of two miscarriages	25	24	0.894
History of ≥3 miscarriages	25	26
Time for complete stoppage of bleeding (Hours)	53.91±9.02	94.57±7.85	0.001
Adverse reactions (%)
Nausea	9	8	0.587
Vomiting	3	4
Abdominal cramps	1	2
Headache, Fatigue	1	-
Vaginal irritation	-	1

DISCUSSION

The various methods of the administration of the progesterone are by intramuscular, vaginal, and the oral routes. The most preferred method by the patients is the oral route. The findings of our study show that there was no significant variation for the adverse effects between the groups nor there was any continuation till second trimester. The vaginal progesterone showed fewer side effects. However, there was a significant difference for the stoppage of the pervaginal bleeding, with quicker stoppage in the oral dydrogesterone group. Similar observations were done in the studies of Czyzyk et al.,[6] and Mesen et al.[7] There were few limitations in our study, the sample size being smaller. There was no blinding of the investigators that might have led to the bias.

CONCLUSION

Within the limitations of the study, we can summarize that when compared to the vaginal progesterone, oral dydrogesterone has been more efficient in preventing the pervaginal bleeding in the early pregnancy among the women with previous history of miscarriage and a greater viability of the pregnancy till the second trimester end. Further studies are suggested to corroborate our findings.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.