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"Contraceptives, Postcoital"
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Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis
by
Van Horn, Jennifer
,
Mathe, Henri
,
Casale, William
in
Adult
,
Biological and medical sciences
,
Birth control
2010
Emergency contraception can prevent unintended pregnancies, but current methods are only effective if used as soon as possible after sexual intercourse and before ovulation. We compared the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception.
Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment in this randomised, multicentre, non-inferiority trial. 2221 women were randomly assigned to receive a single, supervised dose of 30 mg ulipristal acetate (n=1104) or 1·5 mg levonorgestrel (n=1117) orally. Allocation was by block randomisation stratified by centre and time from unprotected sexual intercourse to treatment, with allocation concealment by identical opaque boxes labelled with a unique treatment number. Participants were masked to treatment assignment whereas investigators were not. Follow-up was done 5–7 days after expected onset of next menses. The primary endpoint was pregnancy rate in women who received emergency contraception within 72 h of unprotected sexual intercourse, with a non-inferiority margin of 1% point difference between groups (limit of 1·6 for odds ratio). Analysis was done on the efficacy-evaluable population, which excluded women lost to follow-up, those aged over 35 years, women with unknown follow-up pregnancy status, and those who had re-enrolled in the study. Additionally, we undertook a meta-analysis of our trial and an earlier study to assess the efficacy of ulipristal acetate compared with levonorgestrel. This trial is registered with ClinicalTrials.gov, number NCT00551616.
In the efficacy-evaluable population, 1696 women received emergency contraception within 72 h of sexual intercourse (ulipristal acetate, n=844; levonorgestrel, n=852). There were 15 pregnancies in the ulipristal acetate group (1·8%, 95% CI 1·0–3·0) and 22 in the levonorgestrel group (2·6%, 1·7–3·9; odds ratio [OR] 0·68, 95% CI 0·35–1·31). In 203 women who received emergency contraception between 72 h and 120 h after sexual intercourse, there were three pregnancies, all of which were in the levonorgestrel group. The most frequent adverse event was headache (ulipristal acetate, 213 events [19·3%] in 1104 women; levonorgestrel, 211 events [18·9%] in 1117 women). Two serious adverse events were judged possibly related to use of emergency contraception; a case of dizziness in the ulipristal acetate group and a molar pregnancy in the levonorgestrel group. In the meta-analysis (0–72 h), there were 22 (1·4%) pregnancies in 1617 women in the ulipristal acetate group and 35 (2·2%) in 1625 women in the levonorgestrel group (OR 0·58, 0·33–0·99; p=0·046).
Ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse.
HRA Pharma.
Journal Article
Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial
2020
Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception.
We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete).
Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2–35·0) in the intervention group (mean 58·4%, 48·6–68·2), than in the control group (mean 40·5%, 29·7–51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred.
Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception.
National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).
Journal Article
Emergency Contraception
by
Casey, Petra M.
,
Batur, Pelin
,
Kransdorf, Lisa N.
in
Administration, Oral
,
Attitude of Health Personnel
,
Body Mass Index
2016
Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m2 may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.
Journal Article
Ulipristal Acetate: Review of the Efficacy and Safety of a Newly Approved Agent for Emergency Contraception
2012
Emergency contraception (EC) is used to prevent unintended pregnancies. The current gold standard for oral EC is levonorgestrel (LNG) administered as a single 1.5-mg dose or in 2 doses of 0.75 mg separated by 12 hours. LNG has shown to be effective up to 72 hours after coitus. Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for EC use in the United States in August 2010. UPA is administered as a one-time, 30-mg dose within 120 hours of intercourse.
The goal of this review was to provide a summary of the available literature on the use of UPA for EC.
PubMed, Cochrane Library, ClinicalTrials.gov, International Pharmaceutical Abstracts, EBSCO, and Iowa Drug Information Service were searched from February 2011 through September 2011 to identify relevant articles. Search terms included ulipristal acetate, CDB-2914, VA 2914, and emergency contraception.
In an open-label study, UPA was effective in preventing pregnancy in 1241 women who presented for EC up to 120 hours (5 days) after unprotected intercourse, with an observed pregnancy rate of 2.1% (95% CI, 1.4%–3.1%) versus 5.5% (ie, the expected pregnancy rate without EC). The efficacy of UPA did not decrease significantly (P = 0.44) over time, with pregnancy rates at intervals between >48 and 72 hours at 2.3% (95% CI, 1.4%–3.8%), >72 and 96 hours at 2.1% (95% CI, 1.0%–4.1%), and >96 and 120 hours at 1.3% (95% CI, 0.1%–4.8%). In a single-blind, comparative noninferiority study of 1696 women, UPA was at least as effective as LNG when used within 72 hours for EC, with 15 pregnancies in the UPA group and 22 pregnancies in the LNG group (odds ratio = 0.68 [95% CI, 0.35–1.31]). In addition, UPA prevented significantly (P = 0.037) more pregnancies than LNG when used between 72 and 120 hours after unprotected intercourse, with 0 pregnancies in the UPA group and 3 pregnancies in the LNG group. In a meta-analysis, UPA prevented a greater percentage of pregnancies than LNG at intervals up to 24 hours (0.9% UPA vs 2.5% LNG; P = 0.035), up to 72 hours (1.4% UPA vs 2.2% LNG; P = 0.046), and up to 120 hours (1.3% UPA vs 2.2% LNG; P = 0.025). The most commonly (>10%) reported adverse events included headache, nausea, and abdominal pain. In addition, UPA delayed onset of menstruation by a mean of 2.1 to 2.8 days.
Based on clinical trials, UPA seems to be a reasonably tolerable and effective method of EC when used within 120 hours of intercourse. UPA is at least as effective as LNG when used within the first 72 hours after unprotected intercourse. However, UPA may be more effective than LNG when used between 72 to 120 hours after unprotected intercourse, extending the window of opportunity for EC. UPA may provide a new option for women who require EC up to 5 days after unprotected intercourse.
Journal Article
Determinants of emergency contraceptive use among female senior high school students in the Akuapem south municipality, Ghana
by
Bediako, Cynthia
,
Asempah, Frank
,
Djirackor, Fortune
in
Adolescent
,
Analysis
,
Contraception Behavior - psychology
2026
This study investigated the knowledge, awareness, and use of emergency contraceptives (ECs) among female Senior High School students in the Akuapem South Municipality of Ghana, guided by the Theory of Planned Behaviour (TPB). A cross-sectional quantitative design was employed, surveying 300 students from two schools. Data were collected using a structured, self-administered questionnaire and analyzed with descriptive statistics and regression models. Results showed while awareness of ECs was high (98%), its actual use was moderate (50%). Attitude (p<0.001) and subjective norms (p<0.001) significantly predicted intention, while perceived behavioural control (p<0.005) predicted actual use of emergency contraceptives. Mean construct scores reflected positive attitudes (M=3.9), low subjective norms (M=2.7), moderate perceived control (M=3.5), weak intentions (M=2.8), and low reported behaviour (M=2.6). Cultural, religious, and moral concerns were major deterrents to EC use. The findings highlighted the need for culturally sensitive interventions to: bridge the gap between awareness and effective use of ECs, that would help reduce unintended pregnancies among students (including adolescents) in Ghana.
Journal Article
Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial
by
Piaggio, Gilda
,
Cheng, Weiyu
,
Ding, Juhong
in
Adult
,
Biological and medical sciences
,
Birth control
2002
A single 10 mg dose of mifepristone, and two 0·75 mg doses of levonorgestrel 12 h apart, are effective for emergency contraception. Because no studies had compared the efficacies of both compounds, or investigated a single dose of 1·5 mg levonorgestrel, we undertook this three-arm trial.
We did a randomised, double-blind trial in 15 family-planning clinics in 10 countries. We randomly assigned 4136 healthy women with regular menstrual cycles, who requested emergency contraception within 120 h of one unprotected coitus, to one of three regimens: 10 mg singledose mifepristone; 1·5 mg single-dose levonorgestrel; or two doses of 0·75 mg levonorgestrel given 12 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Analysis was by intention to treat, but we did exclude some patients from the final analyses.
Of 4071 women with known outcome, pregnancy rates were 1·5% (21/1359) in those given mifepristone, 1·5% (20/1356) in those assigned single-dose levonorgestrel, and 1·8% (24/1356) in women assigned two-dose levonorgestrel. These proportions did not differ significantly (p=0·83). The relative risk of pregnancy for single-dose levonorgestrel compared with two-dose levonorgestrel was 0·83 (95% Cl 0·46–1·50), and that for levonorgestrel (the two regimens combined) compared with mifepristone, 1·05 (0·63–1·76). Side-effects were mild and did not differ greatly between groups, and most women menstruated within 2 days of the expected date. Women who took levonorgestrel had earlier menses than did those who took mifepristone.
The three regimens studied are very efficacious for emergency contraception and prevent a high proportion of pregnancies if taken within 5 days of unprotected coitus. Mifepristone and levonorgestrel do not differ in efficacy. A 1·5 mg single levonorgestrel dose can substitute two 0·75 mg doses 12 h apart.
Journal Article
Practice and determinants of emergency contraceptive utilization among women seeking termination of pregnancy in Northwest Ethiopia—A mixed quantitative and qualitative study
2022
Emergency contraceptives are used within 72 hours after unprotected sexual intercourse to prevent unwanted pregnancy. Although emergency contraceptives are widely available in Ethiopia, termination of pregnancy remains a public health problem indicating low uptake of emergency contraceptives after unprotected sexual intercourse. This study aimed to assess utilization and determinants of emergency contraceptives among women seeking termination of pregnancy in Northwest Ethiopia.
An institutional-based cross-sectional study was carried out, supplemented by phenomenologically approached in-depth interviews. Systematic random sampling was used to select study participants. A structured questionnaire and an in-depth interview guide were used to collect data. Data were entered by EPI-info and analyzed through SPSS version 23 to conduct logistic regressions. Thematic analysis was used to conduct qualitative interpretation.
Almost one-fifth (78; 19.2%) of the study participants used emergency contraceptives to prevent their index pregnancy. Women who had secondary education (aOR 3.28; 95% CI 1.59, 6.79) and women who had no living children (aOR 4.52; 95% CI 1.40, 14.57) had a positive significant association with emergency contraceptive utilization. On the other hand, women who did not discuss contraceptives with their sexual partner (aOR 0.49; 95% CI 0.27-0.91) and women without a history of abortion (aOR 0.45; 95% CI 0.24-0.97) had a negative significant association with emergency contraceptive utilization.
There is relatively low utilization of emergency contraception among pregnancy terminating women. Reproductive health programs should encourage women discussion with their partners about emergency contraceptives to decrease occurrence of unwanted pregnancy and termination of pregnancy.
Journal Article
A systematic review and meta-analysis of attitude and knowledge involving emergency oral contraceptive use in patients and healthcare providers
by
Parmontree, Porntip
,
Leelakanok, Nattawut
,
Petchsomrit, Arpa
in
Acetic acid
,
Attitudes
,
Fertilization
2022
BackgroundLevonorgestrel and ulipristal acetate are common emergency oral contraceptives (EOCs). Lack of knowledge and negative attitude toward EOCs pose barriers to the EOCs access and utilization.AimThis study aimed to summarize the studies on the knowledge and attitudes of healthcare providers and patients on the use of EOCs.MethodA systematic search was conducted from conception to April 2022 using the following databases: CINAHL Complete, MEDLINE, ScienceDirect, Scopus, and Thai Journal Online. Data were extracted independently and were meta-analyzed using DerSimonian and Laird method for the binary random-effects model.Results121 articles with a total number of 92,484 participants were included. The awareness of levonorgestrel as an EOC was 66.7% while the awareness of ulipristal acetate as an EOC was 36.9%. EOCs users received EOC information mainly from the internet, media, and friends. We found that 32.2% of EOCs users and providers agreed that EOCs acted post-fertilization, and 39.8% of the prescribers know the correct time to take the pill postcoital. Negative attitudes toward EOC use were found in 25.4% of the participants. For example, 39.4% of the participants agreed that EOCs users had increased sexual activity.ConclusionThe awareness of EOCs was low and misunderstandings or negative attitudes towards the use or prescription of EOCs were still prevalent. Educating healthcare providers, using media as educational tools, and improving education and economics can be useful in improving EOC users' awareness, knowledge, and attitude towards EOCs.
Journal Article
Knowledge and use of emergency contraceptives amid women seeking termination of pregnancy in the North West province
2025
BackgroundDespite acceptable contraceptive coverage rates in South Africa, the rise in the number of termination of pregnancies is worrisome and suggests that family planning services are not yet optimal. Emergency contraceptives are underutilised in South Africa.AimTo assess the knowledge and use of emergency contraceptives among women presenting to a termination of pregnancy (TOP) facility.SettingThe study was conducted in the JB Marks sub-district, North West province, South Africa.MethodsThis cross-sectional study was based at the TOP clinic at Potchefstroom Hospital, North West province. One hundred and ninety-six women completed self-administered questionnaires. Completion of the questionnaire was considered consent. Descriptive statistics were performed, and Chi2 and Fischer exact test were used to determine relationships between variables.ResultsThe mean age of participants was 26.5 years (standard deviation [s.d.] = 5.87), with 114 (58.2%) participants being single women in their 20s. Among 162 participants who had never used emergency contraceptives, 64.8% cited a lack of knowledge as the primary barrier to use. Only 34 (17.4%) of participants have previously used emergency contraceptives. The main reason for poor uptake among the women who never used emergency contraceptives could be attributed to poor knowledge.ConclusionThis study highlighted that knowledge and usage of emergency contraception are low in women presenting for TOP in the health sub-district. Emergency contraceptives can reduce the number of unintended pregnancies and its associated trauma significantly. Community intervention should be of utmost importance to improve the knowledge and usage of emergency contraception.ContributionThis study emphasised the need to make young adults aware of emergency contraceptives to avoid the trauma of unintended pregnancy for women.
Journal Article