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Tara C Jatlaoui - One of the best experts on this subject based on the ideXlab platform.
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Expulsion of intrauterine devices after postpartum placement by timing of placement delivery type and intrauterine device type a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Sarah Averbach, Yokabed Ermias, Gary Jeng, Kathryn M Curtis, Maura K Whiteman, Erin Berrybibee, Denise J Jamieson, Polly A Marchbanks, Naomi K Tepper, Tara C JatlaouiAbstract:Abstract: Objectives To provide updated and more detailed pooled IUD Expulsion rates and Expulsion risk estimates among women with postpartum IUD placement by timing of insertion, delivery type, and IUD type to inform current IUD insertion practices in the United States. Data sources We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. Study eligibility criteria We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or Levonorgestrel (LNG)-containing IUDs that reported counts of Expulsion. Study appraisal and synthesis methods We evaluated IUD Expulsion among women receiving postpartum IUDs in the ‘immediate’ (within 10 minutes), ‘early inpatient’ (greater than 10 minutes to less than 72 hours), ‘early outpatient’ (72 hours to less than 4 weeks) and interval (4 weeks or greater) time periods after delivery. We assessed study quality using the U.S. Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of partial and complete IUD Expulsion separately and estimated adjusted relative risks by the timing of postpartum placement, delivery type and IUD type using log-binomial multivariable regression. Results We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7,661 IUD placements. Complete IUD Expulsion rates varied by timing of placement: 10.2% (range 0.0-26.7) for immediate, 13.2% (3.5-46.7) for early inpatient, 0% for early outpatient, and 1.8% (0.0-4.8) for interval placements. Complete IUD Expulsion rates also varied by delivery type: 14.8% (range 4.8-43.1) for vaginal and 3.8% (0.0-21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the Expulsion rate for LNG-IUDs was 27.4% (18.8-45.2) and 12.4% (4.8-43.1) for copper IUDs. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete Expulsions (adjusted RR (aRR), 8.33; 95% CI, 4.32-16.08 and aRR, 5.27; 95% CI, 2.56–10.85, respectively). Among immediate postpartum placements, risk of Expulsion was greater for placement after vaginal compared with cesarean deliveries (aRR, 4.57; 95% CI, 3.49-5.99). Among immediate placements at the time of vaginal delivery, LNG-IUDs were associated with a greater risk of Expulsion compared with copper IUDs (aRR, 1.90; 95% CI, 1.36-2.65). Conclusion While IUD Expulsion rates vary by timing of placement, type, and mode of delivery, IUD insertion can take place at any time. Understanding the risk of IUD Expulsion at each time period will enable women to make an informed choice about when to initiate an IUD in the postpartum period based on her own goals and preferences.
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Expulsion of intrauterine devices after postpartum placement by timing of placement delivery type and intrauterine device type a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Sarah Averbach, Yokabed Ermias, Gary Jeng, Kathryn M Curtis, Maura K Whiteman, Erin Berrybibee, Denise J Jamieson, Polly A Marchbanks, Naomi K Tepper, Tara C JatlaouiAbstract:Objectives To provide updated and more detailed pooled intrauterine device Expulsion rates and Expulsion risk estimates among women with postpartum intrauterine device placement by timing of insertion, delivery type, and intrauterine device type to inform current intrauterine device insertion practices in the United States. Data Sources We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. Study Eligibility Criteria We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or levonorgestrel-containing intrauterine devices that reported counts of Expulsion. Study Appraisal and Synthesis Methods We evaluated intrauterine device Expulsion among women receiving postpartum intrauterine devices in the “immediate” (within 10 minutes), “early inpatient” (>10 minutes to Results We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7661 intrauterine device placements. Complete intrauterine device Expulsion rates varied by timing of placement as follows: 10.2% (range, 0.0−26.7) for immediate; 13.2% (3.5−46.7) for early inpatient; 0% for early outpatient; and 1.8% (0.0−4.8) for interval placements. Complete intrauterine device Expulsion rates also varied by delivery type: 14.8% (range, 4.8−43.1) for vaginal and 3.8% (0.0−21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the Expulsion rate for levonorgetrel intrauterine devices was 27.4% (range, 18.8−45.2) and 12.4% (4.8−43.1) for copper intrauterine devices. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete Expulsion (adjusted risk ratio, 8.33; 95% confidence interval, 4.32−16.08, and adjusted risk ratio, 5.27; 95% confidence interval, 2.56–10.85, respectively). Among immediate postpartum placements, risk of Expulsion was greater for placement after vaginal compared with cesarean deliveries (adjusted risk ratio, 4.57; 95% confidence interval, 3.49−5.99). Among immediate placements at the time of vaginal delivery, levonorgestrel intrauterine devices were associated with a greater risk of Expulsion compared with copper intrauterine devices (adjusted risk ratio, 1.90; 95% confidence interval, 1.36−2.65). Conclusion Although intrauterine device Expulsion rates vary by timing of placement, type, and mode of delivery, intrauterine device insertion can take place at any time. Understanding the risk of intrauterine device Expulsion at each time period will enable women to make an informed choice about when to initiate use of an intrauterine device in the postpartum period based on their own goals and preferences.
Mitchell D Creinin - One of the best experts on this subject based on the ideXlab platform.
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segesterone acetate ethinyl estradiol 12 month contraceptive vaginal system safety evaluation
Contraception, 2019Co-Authors: Kristina Gemzelldanielsson, Mitchell D Creinin, Regine Sitrukware, Michael A Thomas, Kurt T Barnhart, George W Creasy, Heather Sussman, Mohcine Alami, Anne E Burke, Edith WeisbergAbstract:Abstract Objectives To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. Study design We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies. Results The combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m2] received the final manufactured CVS, of whom 999 (43.3%) completed 13 cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242, 10%) and abdominal pain (n=225, 10%). Few ( 29 kg/m2 (n=2)]. During 21,482 treatment cycles in the phase 3 studies evaluable for Expulsion, women reported partial Expulsions in 4259 (19.5%) cycles and complete Expulsions in 1509 (7%) cycles, most frequently in the initial cycle [499/2050 (24.3%) and 190/2050 (9.3%), respectively]. Safety-focused studies revealed no safety concerns. Conclusion The 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. Implications This 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.
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postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery a randomized controlled trial
Obstetrics & Gynecology, 2010Co-Authors: Beatrice A Chen, Jennifer L Hayes, Matthew F Reeves, Heather L Hohmann, Lisa Perriera, Mitchell D CreininAbstract:The United States has the highest unintended pregnancy rate of any developed country. Of the 6.4 million pregnancies in the United States each year, almost half are unintended (49%).1 Postpartum women are particularly susceptible with an unintended pregnancy rate of 10–44% in the first postpartum year.2–6 These unintended pregnancies occur despite the recommendation that a contraceptive method should be selected before hospital discharge.7 Long-acting reversible contraceptives such as the intrauterine device (IUD) can theoretically help decrease the rate of unintended pregnancy through providing reliable, effective, long-term contraception. However, women who desire an IUD for postpartum contraception often do not receive one for various reasons, including loss of insurance coverage, inability to return for insertion, lack of a health care provider experienced in IUD insertions, and early repeat pregnancy. A US study of 193 women who desired a postpartum IUD found that 35% did not return for a postpartum visit and only 60% actually received an IUD.5 Seven (3.6%) of these women became pregnant before they were able to receive an IUD. Immediate postplacental IUD insertion is defined as IUD insertion within 10 minutes of the Expulsion of the placenta. Although this practice is common in developing countries, it is rare in the United States. The Expulsion rate associated with interval insertion of T-shaped IUDs is approximately 1–4.5% in the first year.8–10 Postplacental insertion has an Expulsion rate ranging from 6% to 20% for T-shaped IUDs over 1 year.11–14 The Expulsion rate is lower for immediate postplacental compared with early (11 minutes to 72 hours) postpartum insertion and is also lower when skilled health care providers insert the IUD.11,12 The method of postpartum insertion, whether inserted by ring forceps or by hand, does not appear to affect Expulsions.11,13 Although the Expulsion rate in postplacental insertion is higher than interval insertion, the benefits of highly effective contraception immediately after delivery may outweigh the risks of Expulsion. Data on postplacental insertion of the levonorgestrel-releasing intrauterine system after vaginal delivery in the United States are limited. A pilot study in the United States of 20 participants who received ultrasonography-guided postplacental insertion of the levonorgestrel-releasing IUD showed an acceptable Expulsion rate of 10% and no infections over a 10-week follow-up.15 The purpose of this study was to compare use of the levonorgestrel-releasing IUD at 6 months postpartum when placed postplacentally after vaginal delivery compared with delayed insertion 6–8 weeks postpartum.
Kristina Gemzelldanielsson - One of the best experts on this subject based on the ideXlab platform.
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segesterone acetate ethinyl estradiol 12 month contraceptive vaginal system safety evaluation
Contraception, 2019Co-Authors: Kristina Gemzelldanielsson, Mitchell D Creinin, Regine Sitrukware, Michael A Thomas, Kurt T Barnhart, George W Creasy, Heather Sussman, Mohcine Alami, Anne E Burke, Edith WeisbergAbstract:Abstract Objectives To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. Study design We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies. Results The combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m2] received the final manufactured CVS, of whom 999 (43.3%) completed 13 cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242, 10%) and abdominal pain (n=225, 10%). Few ( 29 kg/m2 (n=2)]. During 21,482 treatment cycles in the phase 3 studies evaluable for Expulsion, women reported partial Expulsions in 4259 (19.5%) cycles and complete Expulsions in 1509 (7%) cycles, most frequently in the initial cycle [499/2050 (24.3%) and 190/2050 (9.3%), respectively]. Safety-focused studies revealed no safety concerns. Conclusion The 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. Implications This 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.
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early versus delayed insertion of intrauterine contraception after medical abortion a randomized controlled trial
PLOS ONE, 2012Co-Authors: Ingrid Saav, Olof Stephansson, Kristina GemzelldanielssonAbstract:BACKGROUND: Today a large proportion of early abortions are medical terminations in accordance to the womans choice. Intrauterine contraceptives (IUC) provide highly effective reversible long-acting contraception. However the effects of timing of IUC insertion after medical abortion are not known. METHODS: Women undergoing medical abortion with mifepristone and misoprostol up to 63 days gestation and opting for IUC were randomised to early insertion (day 5-9 after mifepristone) or delayed (routine) insertion (at 3-4 weeks after mifepristone). The primary outcome was the rate of IUC Expulsion at six months after IUC insertion. RESULTS: A total of 129 women were randomized and 116 women had a successful IUC insertion. There was no difference in Expulsion rate between early (9.7%) vs. delayed (7.4%) IUC insertion (risk difference -9.2-13.4). Furthermore 1.5% of women randomized to early and 11.5% to delayed insertion did not attend the follow up (proportion difference 10.0% 95% CI: 1.8-20.6% p = 0.015) and a higher proportion of women (41%) had had unprotected intercourse prior to returning for insertion in the delayed group compared with the early group (16%) (p = 0.015). Adverse events were rare and did not differ between the groups. CONCLUSIONS: Early insertion of IUC after medical abortion was safe and well tolerated with no increased incidence for Expulsions or complications. Women were more likely to return for the IUC insertion if scheduled early after the abortion and less likely to have had an unprotected intercourse prior to the IUC insertion. Early insertion should be offered as a routine for women undergoing first trimester medical abortion. TRIAL REGISTRATION: ClinicalTrials.gov NCT01537562.
Edith Weisberg - One of the best experts on this subject based on the ideXlab platform.
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segesterone acetate ethinyl estradiol 12 month contraceptive vaginal system safety evaluation
Contraception, 2019Co-Authors: Kristina Gemzelldanielsson, Mitchell D Creinin, Regine Sitrukware, Michael A Thomas, Kurt T Barnhart, George W Creasy, Heather Sussman, Mohcine Alami, Anne E Burke, Edith WeisbergAbstract:Abstract Objectives To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. Study design We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies. Results The combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m2] received the final manufactured CVS, of whom 999 (43.3%) completed 13 cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242, 10%) and abdominal pain (n=225, 10%). Few ( 29 kg/m2 (n=2)]. During 21,482 treatment cycles in the phase 3 studies evaluable for Expulsion, women reported partial Expulsions in 4259 (19.5%) cycles and complete Expulsions in 1509 (7%) cycles, most frequently in the initial cycle [499/2050 (24.3%) and 190/2050 (9.3%), respectively]. Safety-focused studies revealed no safety concerns. Conclusion The 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. Implications This 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.
Sarah Averbach - One of the best experts on this subject based on the ideXlab platform.
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Expulsion of intrauterine devices after postpartum placement by timing of placement delivery type and intrauterine device type a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Sarah Averbach, Yokabed Ermias, Gary Jeng, Kathryn M Curtis, Maura K Whiteman, Erin Berrybibee, Denise J Jamieson, Polly A Marchbanks, Naomi K Tepper, Tara C JatlaouiAbstract:Abstract: Objectives To provide updated and more detailed pooled IUD Expulsion rates and Expulsion risk estimates among women with postpartum IUD placement by timing of insertion, delivery type, and IUD type to inform current IUD insertion practices in the United States. Data sources We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. Study eligibility criteria We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or Levonorgestrel (LNG)-containing IUDs that reported counts of Expulsion. Study appraisal and synthesis methods We evaluated IUD Expulsion among women receiving postpartum IUDs in the ‘immediate’ (within 10 minutes), ‘early inpatient’ (greater than 10 minutes to less than 72 hours), ‘early outpatient’ (72 hours to less than 4 weeks) and interval (4 weeks or greater) time periods after delivery. We assessed study quality using the U.S. Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of partial and complete IUD Expulsion separately and estimated adjusted relative risks by the timing of postpartum placement, delivery type and IUD type using log-binomial multivariable regression. Results We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7,661 IUD placements. Complete IUD Expulsion rates varied by timing of placement: 10.2% (range 0.0-26.7) for immediate, 13.2% (3.5-46.7) for early inpatient, 0% for early outpatient, and 1.8% (0.0-4.8) for interval placements. Complete IUD Expulsion rates also varied by delivery type: 14.8% (range 4.8-43.1) for vaginal and 3.8% (0.0-21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the Expulsion rate for LNG-IUDs was 27.4% (18.8-45.2) and 12.4% (4.8-43.1) for copper IUDs. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete Expulsions (adjusted RR (aRR), 8.33; 95% CI, 4.32-16.08 and aRR, 5.27; 95% CI, 2.56–10.85, respectively). Among immediate postpartum placements, risk of Expulsion was greater for placement after vaginal compared with cesarean deliveries (aRR, 4.57; 95% CI, 3.49-5.99). Among immediate placements at the time of vaginal delivery, LNG-IUDs were associated with a greater risk of Expulsion compared with copper IUDs (aRR, 1.90; 95% CI, 1.36-2.65). Conclusion While IUD Expulsion rates vary by timing of placement, type, and mode of delivery, IUD insertion can take place at any time. Understanding the risk of IUD Expulsion at each time period will enable women to make an informed choice about when to initiate an IUD in the postpartum period based on her own goals and preferences.
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Expulsion of intrauterine devices after postpartum placement by timing of placement delivery type and intrauterine device type a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Sarah Averbach, Yokabed Ermias, Gary Jeng, Kathryn M Curtis, Maura K Whiteman, Erin Berrybibee, Denise J Jamieson, Polly A Marchbanks, Naomi K Tepper, Tara C JatlaouiAbstract:Objectives To provide updated and more detailed pooled intrauterine device Expulsion rates and Expulsion risk estimates among women with postpartum intrauterine device placement by timing of insertion, delivery type, and intrauterine device type to inform current intrauterine device insertion practices in the United States. Data Sources We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. Study Eligibility Criteria We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or levonorgestrel-containing intrauterine devices that reported counts of Expulsion. Study Appraisal and Synthesis Methods We evaluated intrauterine device Expulsion among women receiving postpartum intrauterine devices in the “immediate” (within 10 minutes), “early inpatient” (>10 minutes to Results We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7661 intrauterine device placements. Complete intrauterine device Expulsion rates varied by timing of placement as follows: 10.2% (range, 0.0−26.7) for immediate; 13.2% (3.5−46.7) for early inpatient; 0% for early outpatient; and 1.8% (0.0−4.8) for interval placements. Complete intrauterine device Expulsion rates also varied by delivery type: 14.8% (range, 4.8−43.1) for vaginal and 3.8% (0.0−21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the Expulsion rate for levonorgetrel intrauterine devices was 27.4% (range, 18.8−45.2) and 12.4% (4.8−43.1) for copper intrauterine devices. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete Expulsion (adjusted risk ratio, 8.33; 95% confidence interval, 4.32−16.08, and adjusted risk ratio, 5.27; 95% confidence interval, 2.56–10.85, respectively). Among immediate postpartum placements, risk of Expulsion was greater for placement after vaginal compared with cesarean deliveries (adjusted risk ratio, 4.57; 95% confidence interval, 3.49−5.99). Among immediate placements at the time of vaginal delivery, levonorgestrel intrauterine devices were associated with a greater risk of Expulsion compared with copper intrauterine devices (adjusted risk ratio, 1.90; 95% confidence interval, 1.36−2.65). Conclusion Although intrauterine device Expulsion rates vary by timing of placement, type, and mode of delivery, intrauterine device insertion can take place at any time. Understanding the risk of intrauterine device Expulsion at each time period will enable women to make an informed choice about when to initiate use of an intrauterine device in the postpartum period based on their own goals and preferences.
