A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding
Introduction: Combined Oral Contraceptive (COC) pills are being used in patients of abnormal uterine bleeding, especially adolescents and reproductive age women considering their need for contraception. It decreases the blood loss due to haemostatic effect of estrogen and also regularizes the c...
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| Format: | Article |
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JCDR Research and Publications Private Limited
2016-03-01
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| Series: | Journal of Clinical and Diagnostic Research |
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| Online Access: | https://jcdr.net/articles/PDF/7516/16545_CE[Ra]_F(Sh)_PF1(BMAK)_PFA(NC_AK)_PF2(PAG).pdf |
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| author | Sandhya Jain Neelam B. Vaid Yam Narang Amita Suneja Kiran Guleria |
| author_facet | Sandhya Jain Neelam B. Vaid Yam Narang Amita Suneja Kiran Guleria |
| author_sort | Sandhya Jain |
| collection | DOAJ |
| description | Introduction: Combined Oral Contraceptive (COC) pills are
being used in patients of abnormal uterine bleeding, especially
adolescents and reproductive age women considering their
need for contraception. It decreases the blood loss due
to haemostatic effect of estrogen and also regularizes the
cycle. Intravaginal route has been found to be effective and
acceptable; Gastrointestinal absorption and hepatic first-pass
metabolism is avoided and steady, uniform blood concentration
is achieved. Bioavailability of estrogen and progestogen through
oral and vaginal route are same. The convenience of once-amonth administration is another major advantage.
Materials and Mathods: Sixty women fulfilling inclusion criteria
were randomised into 2 groups in 1:1 ratio. In one group (n=30),
monthly insertion of Nuvaring®) was done for three consecutive
months. Nuvaring® releases 15µg ethinyl estradiol and 120
µg etonogesterol daily. The other group (n=30) received COC
pill containing 30µg EE and 150 µg levonorgestrel for three
consecutive months. Primary outcome measures were change
in menstrual cycle pattern and pictorial Blood Loss Assessment
chart (PBAC) score. Other Parameters included side effects,
change in haemoglobin and weight. Data was analyzed by
statistical software SPSS 20.
Results: Both Nuvaring® and COC were found to significantly
decrease blood loss in each cycle. Decrease in PBAC score was
more in Nuvaring® group compared to COC, however difference
was not significant.
Ideal bleed (IB) was frequently higher for Nuvaring® group
than COC in all 3 cycles, although no statistically significant
difference was observed between groups (p-value=0.286). Late
withdrawl, intermenstural spotting was higher in COC group.
Compliance was better and women were more satisfied in
Nuvaring® group compared to COC group. Minor side effects
like headache, mastalgia, nausea and mood changes were
seen in both groups, which were not significant. Continuation
rate was significantly higher in Nuvaring® group. 30% women
discontinued treatment in OCP group after 3 month compare to
10% in Nuvaring® group.
Conclusion: Present study shows Nuvaring® to be as effective
as COC in controlling heavy menstural bleed, better cycle
control, with minor acceptable systemic side effects. |
| first_indexed | 2024-12-11T00:42:42Z |
| format | Article |
| id | doaj.art-0662815426e64f48817f0bf6d6fdbd40 |
| institution | Directory Open Access Journal |
| issn | 2249-782X 0973-709X |
| language | English |
| last_indexed | 2024-12-11T00:42:42Z |
| publishDate | 2016-03-01 |
| publisher | JCDR Research and Publications Private Limited |
| record_format | Article |
| series | Journal of Clinical and Diagnostic Research |
| spelling | doaj.art-0662815426e64f48817f0bf6d6fdbd402022-12-22T01:26:52ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2016-03-01103QC21QC2410.7860/JCDR/2016/16545.7516A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine BleedingSandhya Jain0Neelam B. Vaid1Yam Narang2Amita Suneja3Kiran Guleria4Assistant Professor, Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.Professor, Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Senior Resident, Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Professor, Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Professor, Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Introduction: Combined Oral Contraceptive (COC) pills are being used in patients of abnormal uterine bleeding, especially adolescents and reproductive age women considering their need for contraception. It decreases the blood loss due to haemostatic effect of estrogen and also regularizes the cycle. Intravaginal route has been found to be effective and acceptable; Gastrointestinal absorption and hepatic first-pass metabolism is avoided and steady, uniform blood concentration is achieved. Bioavailability of estrogen and progestogen through oral and vaginal route are same. The convenience of once-amonth administration is another major advantage. Materials and Mathods: Sixty women fulfilling inclusion criteria were randomised into 2 groups in 1:1 ratio. In one group (n=30), monthly insertion of Nuvaring®) was done for three consecutive months. Nuvaring® releases 15µg ethinyl estradiol and 120 µg etonogesterol daily. The other group (n=30) received COC pill containing 30µg EE and 150 µg levonorgestrel for three consecutive months. Primary outcome measures were change in menstrual cycle pattern and pictorial Blood Loss Assessment chart (PBAC) score. Other Parameters included side effects, change in haemoglobin and weight. Data was analyzed by statistical software SPSS 20. Results: Both Nuvaring® and COC were found to significantly decrease blood loss in each cycle. Decrease in PBAC score was more in Nuvaring® group compared to COC, however difference was not significant. Ideal bleed (IB) was frequently higher for Nuvaring® group than COC in all 3 cycles, although no statistically significant difference was observed between groups (p-value=0.286). Late withdrawl, intermenstural spotting was higher in COC group. Compliance was better and women were more satisfied in Nuvaring® group compared to COC group. Minor side effects like headache, mastalgia, nausea and mood changes were seen in both groups, which were not significant. Continuation rate was significantly higher in Nuvaring® group. 30% women discontinued treatment in OCP group after 3 month compare to 10% in Nuvaring® group. Conclusion: Present study shows Nuvaring® to be as effective as COC in controlling heavy menstural bleed, better cycle control, with minor acceptable systemic side effects.https://jcdr.net/articles/PDF/7516/16545_CE[Ra]_F(Sh)_PF1(BMAK)_PFA(NC_AK)_PF2(PAG).pdfabnormal uterine bleedingcycle controlnuvaringoral contraceptive pills |
| spellingShingle | Sandhya Jain Neelam B. Vaid Yam Narang Amita Suneja Kiran Guleria A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding Journal of Clinical and Diagnostic Research abnormal uterine bleeding cycle control nuvaring oral contraceptive pills |
| title | A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding |
| title_full | A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding |
| title_fullStr | A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding |
| title_full_unstemmed | A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding |
| title_short | A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding |
| title_sort | randomised controlled trial comparing the efficacy and side effects of intravaginal ring nuvaring r with combined oral hormonal preparation in dysfunctional uterine bleeding |
| topic | abnormal uterine bleeding cycle control nuvaring oral contraceptive pills |
| url | https://jcdr.net/articles/PDF/7516/16545_CE[Ra]_F(Sh)_PF1(BMAK)_PFA(NC_AK)_PF2(PAG).pdf |
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