Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-19 (of 19 Records) |
Query Trace: Gaffield ME[original query] |
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Effectiveness and safety of extending intrauterine device duration: A systematic review
Ti AJ , Roe AH , Whitehouse KC , Smith RA , Gaffield ME , Curtis KM . Am J Obstet Gynecol 2020 223 (1) 24-35 e3 OBJECTIVE: To systematically review the literature to determine if extended use of intrauterine devices including the copper or levonorgestrel intrauterine device beyond approved durations is effective and safe for preventing pregnancy. DATA SOURCES: We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Global Index Medicus from inception through June 2019. STUDY ELIGIBILITY CRITERIA: We considered primary studies of women using the T380A Copper or currently available levonorgestrel intrauterine devices past their approved duration (extended use). The primary outcome was pregnancy. Safety outcomes included adverse events and side effects that led to discontinuation. STUDY APPRAISAL AND SYNTHESIS METHODS: We abstracted study data into evidence tables and assessed study quality as related to the risk of bias, precision, and external validity. For each intrauterine device type, we calculated a pooled pregnancy rate during the first two years of extended use using the Poisson inverse variance method. RESULTS: Of 4,068 studies identified by our search, four good to poor quality studies of the 52 mg levonorgestrel intrauterine device (approved for five years) with a total of 2098 women starting extended use, and two good to fair quality studies of the T380A copper intrauterine device (approved for 10 years) with 245 women starting extended use met inclusion criteria. For the levonorgestrel intrauterine device, the pooled pregnancy rate was 0.02 per 100 person-years (95% confidence interval 0.00-0.45) in year six, 0.03 per 100 person-years (95% confidence interval 0.00-0.71) in year 7, and 0.02 per 100 person-years (95% confidence interval 0.00-0.29) in years six and seven combined. During this same time, annual rates of adverse events or discontinuation due to side effects ranged from 0-3.7 per 100 participants. For the copper intrauterine device, the pooled pregnancy rate for years 11 and 12 was 0.0 per 100 person-years (95% confidence interval 0.0-0.8), and annual rates of adverse events and discontinuation due to side effects during extended use ranged from 0-4.6 per 100 participants. CONCLUSION: The available evidence suggests that rates of pregnancy, adverse events, and discontinuation due to side effects during the first two years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users. |
Dissemination and use of WHO family planning guidance and tools: a qualitative assessment
Kraft JM , Oduyebo T , Jatlaoui TC , Curtis KM , Whiteman MK , Zapata LB , Gaffield ME . Health Res Policy Syst 2018 16 (1) 42 BACKGROUND: As countries continue to improve their family planning (FP) programmes, they may draw on WHO's evidence-based FP guidance and tools (i.e. materials) that support the provision of quality FP services. METHODS: To better understand the use and perceived impact of the materials and ways to strengthen their use by countries, we conducted qualitative interviews with WHO regional advisors, and with stakeholders in Ethiopia and Senegal who use WHO materials. RESULTS: WHO uses a multi-faceted strategy to directly and indirectly disseminate materials to country-level decision-makers. The materials are used to develop national family planning guidelines, protocols and training curricula. Participants reported that they trust the WHO materials because they are evidence based, and that they adapt materials to the country context (e.g. remove content on methods not available in the country). The main barrier to the use of national materials is resource constraints. CONCLUSIONS: Although the system and processes for dissemination work, improvements might contribute to increased use of the materials. For example, providers may benefit from additional guidance on how to counsel women with characteristics or medical conditions where contraceptive method eligibility criteria do not clearly rule in or rule out a method. |
A systematic review and meta-analysis of venous thrombosis risk among users of combined oral contraception
Dragoman MV , Tepper NK , Fu R , Curtis KM , Chou R , Gaffield ME . Int J Gynaecol Obstet 2018 141 (3) 287-294 BACKGROUND: Combined oral contraceptives (COCs) containing various progestogens could be associated with differential risks for venous thromboembolism (VTE). OBJECTIVE: To evaluate the comparative risks of VTE associated with the use of low-dose (less than 50 mug ethinyl estradiol) COCs containing different progestogens. SEARCH STRATEGY: PubMed and the Cochrane Library were searched from database inception through September 15, 2016, by combining search terms for oral contraception and venous thrombosis. SELECTION CRITERIA: Studies reporting VTE risk estimates among healthy users of progestogen-containing low-dose COCs were included. DATA COLLECTION AND ANALYSIS: A random-effects model was used to generate pooled adjusted risk ratios and 95% confidence intervals; subgroup and sensitivity analyses assessed the impact of monophasic-COC use and study-level characteristics. MAIN RESULTS: There were 22 articles included in the analysis. The use of COCs containing cyproterone acetate, desogestrel, drospirenone, or gestodene was associated with a significantly increased risk of VTE compared with the use of levonorgestrel-containing COCs (pooled risk ratios 1.5-2.0). The analysis restricted to monophasic COC formulations with 30 mug of ethinyl estradiol yielded similar findings. After adjustment for study characteristics, the risk estimates were slightly attenuated. CONCLUSIONS: Compared with the use of levonorgestrel-containing COCs, the use of COCs containing other progestogens could be associated with a small increase in risk for VTE. This article is protected by copyright. All rights reserved. |
Development, updates, and future directions of the World Health Organization selected practice recommendations for contraceptive Use
Chen MJ , Kim CR , Whitehouse KC , Berry-Bibee E , Gaffield ME . Int J Gynaecol Obstet 2017 136 (2) 113-119 Correct and consistent use of contraception decreases the risk of unintended pregnancy; yet, outdated policies or practices can delay initiation or hinder continuation of contraceptive methods. To promote the quality of, and access to, family planning services, WHO created a series of evidence-based guidance documents for family planning, known as WHO’s Four Cornerstones of Family Planning Guidance (Fig. 1). The Medical eligibility criteria for contraceptive use (MEC), first published in 1996,1 provides guidance on the safety of various contraceptive methods in users with specific health conditions or characteristics (i.e. who can use a contraceptive method safely). The Selected practice recommendations for contraceptive use (SPR) is the second cornerstone,2 outlining how to safely and effectively use contraceptive methods. These two documents can serve as a reference for policymakers and program managers as they develop their own national family planning policies in the context of local needs, values, and resources. The two other cornerstone documents—the Decision making tool for family planning clients and providers3 and Family planning: a global handbook for providers4—provide guidance to healthcare providers for applying these recommendations in practice. |
Drug interactions between hormonal contraceptives and antiretrovirals: A systematic review
Nanda K , Stuart GS , Robinson J , Gray AL , Tepper NK , Gaffield ME . AIDS 2017 31 (7) 917-952 OBJECTIVE: To summarize published evidence on drug interactions between hormonal contraceptives and antiretrovirals. DESIGN: Systematic review of the published literature. METHODS: We searched PUBMED, POPLINE, and EMBASE for peer-reviewed publications of studies (in any language) from inception through September 21, 2015. We included studies of women using hormonal contraceptives and antiretrovirals concurrently. Outcomes of interest were effectiveness of either therapy, toxicity, and pharmacokinetics. We used standard abstraction forms to summarize and assess strengths and weaknesses. RESULTS: Fifty reports from 46 studies were included. Most antiretrovirals, whether used for therapy or prevention, have limited interactions with hormonal contraceptive methods, with the exception of efavirenz. While DMPA is not affected, limited data on implants and combined oral contraceptive pills suggests that efavirenz-containing combination antiretroviral therapy may compromise contraceptive effectiveness of these methods. However, implants remain very effective despite such drug interactions. Antiretroviral plasma concentrations and effectiveness are generally not affected by hormonal contraceptives. CONCLUSION: Women taking antiretrovirals, for treatment or prevention, should not be denied access to the full range of hormonal contraceptive options, but should be counseled on the expected rates of unplanned pregnancy associated with all contraceptive methods, in order to make their own informed choices. |
Nonoral combined hormonal contraceptives and thromboembolism: A systematic review
Tepper NK , Dragoman MV , Gaffield ME , Curtis KM . Contraception 2016 95 (2) 130-139 BACKGROUND: Combined hormonal contraceptives (CHCs), containing estrogen and progestin, are associated with an increased risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE), compared with non-use. Few studies have examined whether non-oral formulations (including the combined hormonal patch, combined vaginal ring, and combined injectable contraceptives) increase the risk of thrombosis compared with combined oral contraceptives (COCs). OBJECTIVES: To examine the risk of VTE and ATE among women using non-oral CHCs compared to women using COCs. METHODS: We searched the PubMed database for all English language articles published from database inception through May 2016. We included primary research studies that examined women using the patch, ring, or combined injectables compared with women using levonorgestrel-containing or norgestimate-containing COCs. Outcomes of interest included VTE (deep venous thrombosis or pulmonary embolism) or ATE (acute myocardial infarction or ischemic stroke). We assessed the quality of each individual piece of evidence using the system developed by the United States Preventive Services Task Force. RESULTS: Eight studies were identified that met inclusion criteria. Of seven analyses from six studies examining VTE among patch users compared with levonorgestrel or norgestimate-containing COC users, two found a statistically significantly elevated risk among patch users (risk estimates 2.2-2.3), one found an elevated risk that did not meet statistical significance (risk estimate 2.0) and four found no increased risk. Of three studies examining VTE among ring users compared with levonorgestrel COC users, one found a statistically significantly elevated risk among patch users (risk estimate 1.9) and two did not. Two studies did not find an increased risk for ATE among women using the patch compared with norgestimate COCs. We did not identify any studies examining combined injectable contraceptives. CONCLUSION: Limited Level II-2 good to fair evidence demonstrated conflicting results on whether women using the patch or the ring have a higher risk of VTE than women using COCs. Evidence did not demonstrate an increased risk of ATE among women using the patch. Overall, any potential elevated risk likely represents a small number of events on a population level. Additional studies with standard methodology are needed to further clarify any associations and better understand mechanisms of hormone-induced thrombosis among users of non-oral combined hormonal contraception. |
Research gaps identified during the 2014 update of the WHO Medical Eligibility Criteria for Contraceptive Use and Selected Practice Recommendations for Contraceptive Use
Dragoman M , Jatlaoui T , Nanda K , Curtis KM , Gaffield ME . Contraception 2015 94 (3) 195-201 Universal access to safe and effective contraception is an important public health goal. Family planning and prevention of unintended pregnancy are essential to securing the well-being and autonomy of individuals, while supporting the health and development of communities [1]. The World Health Organization (WHO) recently undertook a process to update its global guidance on “who” can use contraception safely and “how” to use contraception safely and effectively to generate the fifth edition of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) and the third edition of the WHO Selected Practice Recommendations for Contraceptive Use (SPR). Overall, the MEC demonstrates that contraception is remarkably safe for most people; at least one highly effective contraceptive method is assigned a category “1” or “2” across the majority of conditions in the guidance, indicating no restrictions on use or that the advantages of using a particular method generally outweigh the theoretical or proven risks of use. Once a medically appropriate method is identified, the SPR offers critical guidance on safe and effective use, important for contraceptive management and service delivery. The major goal for producing these evidence-based recommendations is to help improve access to and strengthen the quality of family planning services worldwide. | While these recommendations reflect a rigorous synthesis and interpretation of the best evidence to date and contribute significantly to medical and public health knowledge around the world, a number of recommendations in both the MEC and SPR are grounded in limited to no direct evidence. Related to safety, conducting research on whether exposure to a contraceptive method would worsen a disease given significant theoretical concerns (e.g., combined hormonal contraceptive use among women with current breast cancer) would be unethical. In other instances, no or very limited published literature directly reports whether or not use of a given method is associated with an important health risk or how best to offer a contraceptive service. In the absence of direct evidence, indirect evidence and expert opinion inform assessments. For example, extrapolating what is known about the safety of contraceptive methods in healthy women to women with medical conditions can be helpful, while taking into account relevant disease processes and how they intersect with what is known generally about the characteristics of methods, associated side effects and potential complications. Even when direct evidence is available, methodological flaws can limit interpretation. The body and certainty of the evidence underpinning the recommendations has increased and improved over time in response to increased and improved contraceptive research. |
Combined hormonal contraceptive use among women with known dyslipidemias: a systematic review of critical safety outcomes
Dragoman M , Curtis KM , Gaffield ME . Contraception 2015 94 (3) 280-7 CONTEXT: Dyslipidaemias represent a spectrum of lipid disorders that are important risk factors for cardiovascular disease. In addition, elevated triglycerides are known to be associated with pancreatitis. Though less clear, it is possible that dyslipidaemias may also contribute to risk for venous thromboembolism. Ethinyl estradiol and progestogen, contained within combined hormonal contraception, are known to impact lipid metabolism. OBJECTIVE: To evaluate from the literature whether use of combined hormonal contraception (CHC), including combined oral contraception pills (COC), transdermal patch, vaginal ring, or injectables, modifies the relative risk of acute myocardial infarction (MI), stroke, venous thromboembolism (VTE) or pancreatitis among women with known dyslipidaemias and to determine if existing lipid abnormalities worsen with CHC use. METHODS: PubMed and the Cochrane Library databases were searched for all articles in all languages published between inception and September 2014 relevant to dyslipidaemia, CHC use, and serious adverse events (MI, stroke, VTE or pancreatitis). The quality of each individual study was assessed using the system for grading evidence developed by the United States Preventive Services Task Force. RESULTS: From 306 articles identified by our search strategy, 3 articles met inclusion criteria. In a poor quality case-control study, women with hypercholesterolemia but no COC use had an increased risk of myocardial infarction (adjusted odds ratio [adj OR] 3.3, 95% confidence interval [CI] 1.6-6.8), as did women who used COCs but did not have hypercholesterolemia (adj OR 2.0, 95% CI 1.4-2.8), compared with non-COC users without hypercholesterolemia; women with both COC use and hypercholesterolemia had an adjusted OR of 24.7 (95% CI 5.6-108.5) compared with women with neither risk factor. A poor quality cohort study examined COC users and reported that women with dyslipidaemia had increased risk for VTE (crude RR 1.39, 95% CI 1.04-1.85) and transient ischemic attacks (TIA) and or cerebrovascular accidents (CVA) (RR: 1.76, 95% CI 1.51 - 2.06) compared to those without dyslipidaemia. Another poor quality cohort study provided direct evidence on changes in lipid levels among COC users with dyslipidaemia. A minority of women with elevated total cholesterol or triglyceride levels at baseline showed normal results (25% and 28%, respectively) after 6cycles of COC use. No evidence regarding risks associated with use of other CHC methods were identified. No evidence was identified for the outcome of pancreatitis. CONCLUSION: Limited data from poor quality observational studies suggest that women with known dyslipidaemias using CHC may be at increased risk for MI and may experience a minimal increase in risk for CVA or VTE. No evidence was identified on risk for pancreatitis in this context. The impact of CHC exposure on the status of lipid abnormalities over time, an intermediate marker for disease, is also unclear. Given the significant limitations of this body of evidence, the importance of access to effective contraception and theoretical concerns raised about the use of CHCs by women with known dyslipidaemias, additional rigorous studies are needed to best estimate true associations. Contraceptive decision-making should include consideration of both the known and theoretical risks of a given CHC method, safety and acceptability of alternative contraceptive methods, and risks associated with unintended pregnancy. |
Combined hormonal contraceptive use among breastfeeding women: an updated systematic review
Tepper NK , Phillips SJ , Kapp N , Gaffield ME , Curtis KM . Contraception 2015 94 (3) 262-74 BACKGROUND: Contraception is important for women who are postpartum, including those who are breastfeeding. Use of combined hormonal contraceptives (CHCs) may affect breastfeeding performance and infant health outcomes. OBJECTIVES: To identify evidence examining clinical outcomes for breastfeeding and infant health among breastfeeding women using combined hormonal contraceptives compared to non-users. SEARCH STRATEGY: We searched the PubMed database for all articles published from database inception through September 30, 2014. SELECTION CRITERIA: We included primary research studies that compared breastfeeding women using CHCs with breastfeeding women using non-hormonal or no contraception, or compared breastfeeding women initiating combined hormonal contraception at early versus later times postpartum. Breastfeeding outcomes of interest included duration, rate of exclusive breastfeeding and timing of supplementation. Infant outcomes of interest included growth, health, and development. RESULTS: Fifteen articles describing 13 studies met inclusion criteria for this review. Studies ranged from poor to fair methodological quality and demonstrated inconsistent effects of combined oral contraceptives (COCs) on breastfeeding performance with COC initiation before or after 6 weeks postpartum; some studies demonstrated greater supplementation and decreased breastfeeding continuation among COC users compared with non-users and others demonstrated no effect. For infant outcomes, some studies found decreases in infant weight gain for COC users compared with non-users when COCs were initiated at < 6 weeks potpartum while other studies found no effect. None of the studies found an effect on infant weight gain when COCs were started after 6 weeks postpartum, and no studies found an effect on other infant health outcomes regardless of time of COC initiation. CONCLUSION: Limited evidence of poor to fair quality demonstrates an inconsistent impact of COCs on breastfeeding duration and success. The evidence also demonstrated conflicting results on whether early initiation of COCs affects infant outcomes, but generally found no negative impact on infant outcomes with later initiation of COCs. The body of evidence is limited by older studies using different formulations and doses of estrogen and poor methodologic quality. Given the significant limitations of this body of evidence, the importance of contraception for postpartum women, and the theoretical concerns that have been raised about the use of combined hormonal contraception by women who are breastfeeding, rigorous studies examining these issues are needed. In addition, postpartum women should be counseled about the full range of safe alternative contraceptive methods, particularly during the first 6 weeks postpartum when the risk of venous thromboembolism is highest and use of estrogen may exacerbate this risk. |
Advance supply of emergency contraception: a systematic review
Rodriguez MI , Curtis KM , Gaffield ML , Jackson E , Kapp N . Contraception 2013 87 (5) 590-601 BACKGROUND: Emergency contraceptive pills (ECPs) are an underutilized means to reduce unintended pregnancy. Advance provision of ECPs may increase timely use, thereby decreasing risk of unintended pregnancy. STUDY DESIGN: We searched MEDLINE and EMBASE through February 2012 for randomized, controlled trials (RCTs) pertaining to safety and efficacy of advance provision of ECP. The quality of each individual study was evaluated using the United States Preventive Services Task Force evidence grading system. RESULTS: The search strategy identified 714 articles. Seventeen papers reported on safety or efficacy of advance ECPs in adult or adolescent women. Any use of ECPs was two to seven times greater among women who received an advanced supply of ECP. However, a summary estimate (RR 0.90, 95% CI 0.69-1.18) of four RCTs did not demonstrate a significant reduction in unintended pregnancy over 12 months when advance provision was compared with standard provision of ECPs. Patterns of contraceptive use, pregnancy rates and incidence of sexually transmitted infections did not vary between treatment and control groups in the majority of studies among either adults or adolescents. CONCLUSION: Available evidence supports the safety of advance provision of ECPs. Efficacy of advance provision compared with standard provision of ECPs in reducing unintended pregnancy rates at the population level has not been demonstrated. |
Retention of intrauterine devices in women who acquire pelvic inflammatory disease: a systematic review
Tepper NK , Steenland MW , Gaffield ME , Marchbanks PA , Curtis KM . Contraception 2012 87 (5) 655-60 BACKGROUND: Women using intrauterine devices (IUDs) are not protected against acquiring pelvic inflammatory disease (PID). If a woman has an IUD in place when she is diagnosed with PID, there is a theoretical concern that presence of an IUD might impact the course of treatment. This review was conducted to evaluate the evidence regarding whether an IUD should be retained or removed if a woman develops PID. STUDY DESIGN: The PubMed database was searched from database inception through April 2012 for all peer-reviewed articles in any language concerning PID in women using IUDs. Articles were included if they examined women with IUDs who developed PID and compared the clinical course of women in whom the IUD was retained versus women in whom the IUD was removed. Articles were excluded if the infection was diagnosed before or at the time of IUD insertion. The quality of each study was assessed using the United States Preventive Services Task Force grading system. RESULTS: Four fair-quality studies met inclusion criteria for this review. One randomized controlled trial showed that women with IUDs removed had longer hospitalizations than those with IUD retention (15% versus 4%, p<.01), although there were no differences in PID recurrences or subsequent pregnancies. Another randomized controlled trial showed no differences in laboratory parameters among women who retained the IUD when compared with women in whom the IUD was removed. One prospective cohort study showed that there were no differences in clinical or laboratory parameters during hospitalization; however, the IUD removal group had a higher proportion hospitalized for more than 2 weeks compared with the IUD retention group (33% versus 19%, p<.05). One randomized controlled trial showed that women who had the IUD removed experienced improved recovery in most clinical signs and symptoms compared with women who retained the IUD. CONCLUSIONS: Three fair-quality studies showed no difference in clinical or laboratory outcomes among women who retained IUDs when compared with women who had IUDs removed, and two of these studies showed that women who had IUDs removed had longer hospitalizations. In contrast, one fair quality study showed improved clinical signs and symptoms among women who had IUDs removed. Overall, women who retained their IUDs had similar or better outcomes than women who had their IUDs removed. |
When can a woman have an intrauterine device inserted? A systematic review
Whiteman MK , Tyler CP , Folger SG , Gaffield ME , Curtis KM . Contraception 2012 87 (5) 666-73 BACKGROUND: Intrauterine device (IUD) insertion during menses may be viewed as preferable by some providers, as it provides reassurance that the woman is not pregnant. However, this practice may result in unnecessary inconvenience and cost to women. The objective of this systematic review is to evaluate the evidence for the effect of inserting IUDs on different days of the menstrual cycle on contraceptive continuation, effectiveness and safety. STUDY DESIGN: We searched the MEDLINE database for peer-reviewed articles published in any language from database inception through March 2012 concerning the effect of inserting copper IUDs (Cu-IUD) or levonorgestrel-releasing IUDs (LNG-IUDs) on different days of the menstrual cycle on contraceptive continuation, effectiveness, and safety. The quality of each individual piece of evidence was assessed using the United States Preventive Services Task Force grading system. RESULTS: We identified eight articles that met the criteria for review. Each study examined the Cu-IUD; no studies were identified that examined the LNG-IUD. Overall, these studies suggest that timing of Cu-IUD insertion has little effect on longer term outcomes (rates of continuation, removal, expulsion, or pregnancy) or on shorter term outcomes (pain at insertion, bleeding at insertion, immediate expulsion). Specifically, there was no evidence to suggest that outcomes were better when Cu-IUD insertions were performed during menses. Limitations of the studies include small sample sizes for insertions performed during later days of the menstrual cycle and non-randomized assignment to timing of insertion. CONCLUSIONS: There is fair evidence (body of evidence grading: II-2, fair) indicating that timing of Cu-IUD insertion has little effect on contraceptive continuation, effectiveness or safety. |
Pregnancy outcomes with an IUD in situ: a systematic review
Brahmi D , Steenland MW , Renner RM , Gaffield ME , Curtis KM . Contraception 2012 85 (2) 131-9 BACKGROUND: While intrauterine devices (IUDs) provide highly effective contraception, pregnancies among IUD users do rarely occur. The objective of this systematic review is to assess the evidence about risks for adverse pregnancy outcomes among women who conceive with an IUD in situ. METHODS: We searched MEDLINE, POPLINE, EMBASE and LILACS databases from inception through April 2011 for peer-reviewed articles containing evidence related to pregnancy outcomes among women who conceived while using copper (Cu) and levonorgestrel-releasing (LNG) IUDs. RESULTS: Nine articles met our inclusion criteria. Women with retained IUDs were at the greatest risk of adverse pregnancy outcomes, including spontaneous abortion, preterm delivery, septic abortion and chorioamnionitis. Cu-IUD removal decreased risks but not to the baseline risk of pregnancies without an IUD. One case series examined the LNG-IUD; when left in situ, 8 in 10 ended in spontaneous abortions. CONCLUSION: Pregnancies complicated by a remaining IUD in situ were at greater risk of adverse pregnancy outcomes. Early IUD removal appeared to improve outcomes but did not entirely eliminate risks. |
Risk of venous thromboembolism during the postpartum period: a systematic review
Jackson E , Curtis KM , Gaffield ME . Obstet Gynecol 2011 117 (3) 691-703 OBJECTIVE: To determine, from the literature, the risk of venous thromboembolism during the postpartum period. DATA SOURCES: We searched PubMed and Cochrane Library databases for all articles (in all languages) published in peer-reviewed journals from database inception through May 2010 for evidence related to incidence of venous thromboembolism in postpartum women. METHODS OF STUDY SELECTION: We included studies reporting relative risk, incidence rate, or cumulative incidence of venous thromboembolism in postpartum women. TABULATION, INTEGRATION, AND RESULTS: We included 15 articles reporting findings from 13 studies. Two studies directly comparing venous thromboembolism during the first 6 weeks postpartum to nonpregnant, nonpostpartum women reported relative effect measures of 21.5 (rate ratio; 95% confidence interval [CI] unable to be calculated) and 84 (odds ratio; 95% CI 31.7-222.6), respectively. A third study reported relative effect measures for deep venous thrombosis (15.2, 95% CI 13.2-17.6; standardized incidence ratio) and pulmonary embolism (9.2, 95% CI 6.5-12.7) separately. Three studies reported incidence rates of venous thromboembolism during the postpartum period (range 25-99 per 10,000 woman-years). We compared these incidence rates to baseline rates among nonpregnant, nonpostpartum women reported in the literature to generate rate ratios; these rate ratios ranged from 2.5 to 21.5. Nine studies reported cumulative incidence proportions of postpartum venous thromboembolism, ranging from 0.14 to 3.24 per 1,000 deliveries at 6 weeks postpartum. Incidence of venous thromboembolism was highest immediately after delivery (standardized incidence ratio for deep venous thrombosis 115.1 [95% CI 96.4-137.0], and for pulmonary embolism 80.7 [95% CI 53.9-117.9]); between 4 and 6 weeks postpartum, risk declined but was still approximately five-times to seven-times that of nonpregnant, nonpostpartum women. CONCLUSION: During the first 6 weeks postpartum, women's risk of venous thromboembolism increased 21.5-fold to 84-fold from baseline in nonpregnant, nonpostpartum women in studies that included an internal reference group. Although incidence of venous thromboembolism declined quickly after delivery, when this risk returns to baseline is not clear from current data. |
Guidance on medical eligibility criteria for contraceptive use: identification of research gaps
Folger SG , Curtis KM , Tepper NK , Gaffield ME , Marchbanks PA . Contraception 2010 82 (1) 113-118 The Centers for Disease Control and Prevention recently developed the United States Medical Eligibility Criteria (MEC) for Contraceptive Use [1], an adaptation of the World Health Organization's (WHO) evidence-based MEC guidance [2] regarding the safety of contraceptive methods for women with specific characteristics and medical conditions. For the majority of conditions covered by the MEC, at least one highly effective contraceptive method is classified as a “1” or “2,” indicating no restriction for use or that the advantages of use generally outweigh any theoretical or proven risks, demonstrating that contraception is remarkably safe for most women. Access to safe and effective contraception is critical for women with underlying medical conditions, as they may face heightened risks in pregnancy. However, despite the significance of this guidance for medical and public health knowledge and for the well-being of reproductive-age women, for some of the safety concerns, there is limited or no direct evidence in the published literature on which to base contraceptive guidance. For example, no studies were identified that examined contraceptive safety for women with a history of peripartum cardiomyopathy (PPCM) [3]. Instead, the systematic review of PPCM considered indirect evidence, including studies on other cardiac outcomes, to inform the recommendations for contraceptive use among these women. For other recommendations in the MEC, even though a body of evidence exists, further research is needed to adequately address outstanding safety concerns. For example, research on the safety of intrauterine device (IUD) use and risk of expulsion among women with uterine fibroids consists only of non-comparative studies; therefore, the extent to which reported outcomes are attributable to IUD use is unknown [4]. Absence of evidence regarding contraceptive safety may be equated by women or their providers with absence of safety and lead to use of less effective methods. Alternatively, absence of evidence may be equated with absence of risk, resulting in use of methods which may potentially place these women at increased risk of adverse events or complications. |
Oral contraceptives and family history of breast cancer
Gaffield ME , Culwell KR , Ravi A . Contraception 2009 80 (4) 372-80 BACKGROUND: Questions remain regarding whether oral contraceptive (OC) use among women with a family history of breast cancer increases disease risk. STUDY DESIGN: We conducted a systematic review by searching MEDLINE and CENTRAL databases for evidence (in all languages) published in peer-reviewed journals from 1966 to July 2008 that provided estimates of breast cancer risk according to family history. Twelve articles were identified and the quality of each study was assessed using the United States Preventive Services Task Force grading system. RESULTS: Results from 10 studies and one pooled analysis of 54 studies suggest that the use of OCs does not significantly modify the risk of breast cancer among women with a familial history of breast cancer; however, evidence from four studies shows that some women may be at a greater risk, particularly women who took OCs prior to 1975. CONCLUSIONS: Current evidence shows that women with a family history of breast cancer do not increase their disease risk by using OCs. |
Use of combined oral contraceptives post abortion
Gaffield ME , Kapp N , Ravi A . Contraception 2009 80 (4) 355-62 BACKGROUND: Providing combined oral contraceptives (COCs) following surgical or medical induced abortion offers women an opportune moment to initiate a reliable contraceptive method. STUDY DESIGN: We conducted a systematic review, searching MEDLINE and The Cochrane Library for articles in any language concerning COC use following spontaneous, induced (medical or surgical) or septic abortion, from 1966 through June 2008. Seven articles were identified and evaluated using the United States Preventive Services Task Force system. RESULTS: Immediate COC initiation after first-trimester medical or surgical induced abortion did not increase side effects or prolong vaginal bleeding compared with use of a placebo, copper-bearing intrauterine device (IUD), nonhormonal contraceptive method or COC initiation at a later time. Initiating COCs after first-trimester surgical abortion produced small increases in coagulation parameters compared with IUD use; although they are statistically significant, their clinical relevance is unlikely. No study examined second-trimester induced or spontaneous abortion, or septic abortion. CONCLUSIONS: Evidence shows that COCs can be safely initiated immediately following surgical and medical abortion in the first-trimester of pregnancy. |
Combined oral contraceptive and intrauterine device use among women with gestational trophoblastic disease
Gaffield ME , Kapp N , Curtis KM . Contraception 2009 80 (4) 363-71 BACKGROUND: Women diagnosed with gestational trophoblastic disease (GTD) need safe and effective contraception because they are advised to delay a subsequent pregnancy. STUDY DESIGN: We searched MEDLINE and The Cochrane Library for articles in any language on use of combined oral contraceptives (COC), copper-bearing or levonorgestrel-releasing IUDs among women with benign or malignant GTD, from database inception through November 2008. One review and nine articles were identified and evaluated. RESULTS: Incidence of postmolar trophoblastic disease was lower among COC users compared with nonusers in six studies, but higher among COC users in three studies. Five studies reported shorter human chorionic gonadotropin (hCG) regression duration among COC users compared with other methods. Development of postmolar trophoblastic disease did not differ significantly among IUD users compared with COC users or nonusers in three studies. CONCLUSIONS: Evidence shows that postmolar trophoblastic disease risk does not increase among women using COCs or an IUD following molar pregnancy evacuation compared with use of other contraceptive methods or no method. |
Progestogen-only contraceptive use in obese women
Curtis KM , Ravi A , Gaffield ML . Contraception 2009 80 (4) 346-54 BACKGROUND: The objective of this systematic review is to determine whether obese women who use progestogen-only contraceptives are more likely to experience weight gain or serious adverse events as compared to nonobese users. STUDY DESIGN: We searched PubMed for all articles (in all languages) published in peer-reviewed journals from database inception through October 2008, for evidence relevant to obesity and progestogen-only contraceptives. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. RESULTS: From 579 articles, we identified nine studies fitting our selection criteria. Evidence from five studies suggests that among adult women, baseline weight or body mass index is not associated with weight gain among depot medroxyprogesterone acetate (DMPA) users (Level II-2, Fair). Evidence from three studies suggests that among adolescent women, overweight or obese DMPA users may gain more weight than normal weight DMPA users or overweight/obese nonusers (Level II-2, Fair). Evidence from one small study of Norplant users showed no differences in weight gain by baseline weight (Level II-3, Poor). We did not identify studies of other progestogen-only contraceptive methods that examined weight change by baseline weight, nor did we identify studies that reported on any serious adverse events by baseline weight. CONCLUSIONS: Adolescent DMPA users who are obese may gain more weight than normal weight users. This observation was not seen in adult DMPA users or adolescent Norplant users. |
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