Paul D Blumenthal

Stanford University, Palo Alto, California, United States

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Publications (136)685.34 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: We conducted a systematic review of the literature on the effectiveness of medical abortion "reversal" treatment. Since the usual care for women seeking to continue pregnancies after ingesting mifepristone is expectant management with fetal surveillance, we also performed a systematic review of continuing pregnancy after mifepristone alone. We searched PubMed, CINAHL, Scopus, and the Cochrane Library for articles published through March 2015 reporting the proportion of pregnancies continuing after treatment with either mifepristone alone or after an additional treatment following mifepristone aimed at reversing its effect. From 1,115 articles retrieved, 1 study met inclusion criteria for abortion reversal, and 13 studies met criteria for continuing pregnancy after mifepristone alone. The one report of abortion reversal was a case series of 7 patients receiving varying doses of progesterone in oil intramuscularly or micronized progesterone orally or vaginally; 1 patient was lost to follow-up. The study was of poor quality and lacked clear information on patient selection. Four of six women continued the pregnancy to term (67%, 95% CI 30%-90%). Assuming the lost patient aborted resulted in a continuing pregnancy proportion of 57% (95% CI 25%-84%). The proportion of pregnancies continuing 1-2 weeks after mifepristone alone varied from 8% (95% CI 3%-22%) to 46% (95% CI 37-56%). Continuing pregnancy was more common with lower mifepristone doses and advanced gestational age. In the rare case that a woman changes her mind after starting medical abortion, evidence is insufficient to determine whether treatment with progesterone after mifepristone results in a higher proportion of continuing pregnancies compared to expectant management. Legislation requiring physicians to inform patients about abortion reversal transforms an unproven therapy into law and represents legislative interference in the patient-physician relationship. Copyright © 2015. Published by Elsevier Inc.
    Contraception 06/2015; DOI:10.1016/j.contraception.2015.06.001
  • Contraception 05/2015; 91(5). DOI:10.1016/j.contraception.2015.02.010
  • Fertility and Sterility 09/2014; 102(3):e310. DOI:10.1016/j.fertnstert.2014.07.1052
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    ABSTRACT: To investigate mifepristone as a potential adjunct to cervical preparation for surgical abortion after 19weeks gestation, with the aim of improving procedure access, convenience and comfort. Site stratified, block randomized, non-inferiority trial of 50 women undergoing surgical abortion between 19-23 6/7weeks gestation randomized to receive either one set of osmotic dilators plus mifepristone the day prior to procedure (mifepristone group), or two sets of osmotic dilators (placed 18-24 hours apart) in the two days prior to procedure (control group). All subjects received pre-procedure misoprostol. Primary outcome was procedure time. Secondary outcomes included pre-operative cervical dilation, ease of procedure and side effects and pain experienced by subjects. Mean gestational age was similar between groups (20weeks); more nulliparous subjects were randomized to the mifepristone group (46% vs 12%, p=0.009). Mean procedure times were similar: mifepristone group 11:52 (SD 5:29) vs. control group 10:56 (SD 5:08); difference in means -56seconds, with confidence interval (95% CI -4:09 to +2:16) not exceeding the 5minute difference we a priori defined as clinically significant. Pre-procedure cervical dilation did not differ and was >3cm for the majority of subjects in both groups. There was no difference (p=0.6) in ease of procedure reported by providers. Pre-operative (post misoprostol) pain levels were greater with mifepristone (p=0.005) while post-operative pain did not differ (p=0.45). Overall subject experience was not different (p=0.73), with most reporting a "better than expected" experience. Mifepristone with one set of osmotic dilators and misoprostol did not result in longer procedure times or less cervical dilation than serial (two sets) of osmotic dilators and misoprostol, and has the potential to improve access to second trimester abortion without compromising safety. Use of mifepristone for cervical preparation before surgical abortion after 19weeks allows for fewer visits and fewer osmotic dilators without compromising cervical dilation or increasing procedure time. Copyright © 2014. Published by Elsevier Inc.
    Contraception 05/2014; 89(5):479–480. DOI:10.1016/j.contraception.2014.02.019
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    ABSTRACT: The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.
    Contraception 02/2014; 89(5). DOI:10.1016/j.contraception.2014.02.026
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    ABSTRACT: To investigate phone follow-up with a semiquantitative urine pregnancy test and symptom checklist as a replacement for universal clinic follow-up after medical abortion. One thousand four hundred thirty-three women seeking early medical abortion at four hospitals in Vietnam were randomized to clinic or phone follow-up. Women allocated to clinic follow-up returned to the hospital for confirmation of abortion outcome 2 weeks after mifepristone administration. Women assigned to phone follow-up completed a semiquantitative pregnancy test at initial visit to determine baseline human chorionic gonadotropin range and again at home 2 weeks later. Clinic staff called women to review the pregnancy test results and symptom checklist. Women who screened positive were referred to the clinic. Effectiveness, feasibility, and acceptability of the follow-up methods were assessed. The rate of ongoing pregnancy was not significantly different between the two groups (clinic: 2.7% phone, 2.5%, relative risk 0.9, 95% confidence interval 0.99-1.02). Eighty-five percent of women in the phone group did not need an additional clinic visit. Phone follow-up was highly effective in screening for ongoing pregnancy with a sensitivity and specificity of 92.8% and 90.6%, respectively. Specificity of the pregnancy test alone (eg, without the symptom checklist) was higher (95.7%). Phone follow-up offers a feasible and effective approach to identify women with ongoing pregnancy after early medical abortion. When used with the semiquantitative pregnancy test, the symptom checklist offered no additional benefit and decreased the specificity of the screening. Given its effectiveness and ease of use, the semiquantitative pregnancy test alone could replace routine clinic follow-up after early medical abortion. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01150422. : I.
    Obstetrics and Gynecology 01/2014; 123(1):88-95. DOI:10.1097/AOG.0000000000000050
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    Paul D Blumenthal, Maxine Eber, Jyoti Vajpayee
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    ABSTRACT: A specially designed inserter aims at facilitating IUD insertion within 10 minutes to 48 hours after delivery during the postpartum period when demand for, and health benefits of, contraception are high.
    Global Health: Science and Practice 11/2013; 1(3):428-429. DOI:10.9745/GHSP-D-13-00151
  • Paul D Blumenthal
    Current opinion in obstetrics & gynecology 10/2013; DOI:10.1097/GCO.0000000000000031
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    ABSTRACT: To examine the effect of the interval between mifepristone and misoprostol administration on induction time (first misoprostol dose to abortion), total procedure time (mifepristone administration to abortion), and safety and efficacy in second-trimester induction abortion (13-24 weeks). We searched MEDLINE (1966-2012), ClinicalTrials.gov, POPLINE, and the Cochrane Controlled Trials Register using search terms for second trimester, abortion, misoprostol, and mifepristone and reviewed reference lists of published reports. Our search revealed 138 articles of which 29 met inclusion criteria: 20 randomized controlled trials and nine observational studies. Studies were included if, in any study arm, mifepristone and misoprostol were used for medical abortion in the second trimester. Two authors independently reviewed the articles and abstracted the data using standardized data abstraction templates to summarize data. Discrepancies were resolved by consensus. Three studies directly compared a 1-day to 2-day mifepristone-misoprostol interval; they showed small differences in median induction times (weighted average 7.3 hours, range 7-8.5 for a 1-day interval; weighted average 6.8 hours, range 6.3-7.2 for a 2-day interval) and no significant difference in percent expelled by 12 hours or 24 hours. When all randomized studies using mifepristone and misoprostol were pooled by comparable mifepristone-misoprostol interval and misoprostol dose, induction times (first misoprostol dose to expulsion) were only 1-2 hours longer for a 12- to 24-hour interval compared with a 36-48-hour interval, whereas total abortion times (mifepristone to expulsion) were at least 18 hours longer in the 36- to 48-hour group. Induction times varied by misoprostol dosing, with 400-microgram misoprostol protocols resulting in shorter induction times than 200-microgram protocols. Shortening the mifepristone-misoprostol interval, thereby reducing total abortion time, does not compromise the safety or efficacy of second-trimester medication abortion and may be used to accommodate patient or health care provider preference.
    Obstetrics and Gynecology 06/2013; 121(6):1335-47. DOI:10.1097/AOG.0b013e3182932f37
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    ABSTRACT: OBJECTIVE: To simplify follow-up after medical abortion by examining whether women could use a semi-quantitative pregnancy test at home to screen for ongoing pregnancy. METHODS: Three hundred women seeking medical abortion at a tertiary hospital in Vietnam participated in the study. Participants used a semi-quantitative pregnancy test at the hospital to estimate baseline human chorionic gonadotropin (hCG) levels and administered another test at home 2weeks later for comparison. Women interpreted the test result at home and then returned to hospital for follow-up care. At this visit, self-assessment was verified. To assess further the feasibility of the test as a follow-up tool in service delivery, 200 additional women completed a user comprehension survey. RESULTS: The tests identified all 11 ongoing pregnancies among study participants (100% sensitivity; 89.7% specificity). Women reported that the test was easy to use (255/292 [87.3%]) and that provider instructions helped them to use the test (291/292 [99.7%]). CONCLUSION: Semi-quantitative pregnancy tests offer high sensitivity and negative predictive value. If user instructions can be further simplified, the tests could be used in lieu of transvaginal ultrasound and/or serum hCG at clinic-based follow-up or by women themselves for home-based follow-up. Clinical trials.gov:NCT01150279.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 03/2013; 121(2). DOI:10.1016/j.ijgo.2012.11.022
  • Lee A Trope, Bandit Chumworathayi, Paul D Blumenthal
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    ABSTRACT: OBJECTIVE: This study aimed to assess the safety, acceptability and feasibility of primary human papillomavirus (HPV) testing for cervical cancer prevention at the community level in a low-resource setting. MATERIALS AND METHODS: After training a technician to run specimens on the careHPV unit, the study team traveled to a different village each day in rural Roi-et Province, Thailand. Women were tested for HPV using self-swab, followed by careHPV testing. Those with positive result were assessed immediately by visual inspection with acetic acid. Women positive for HPV and visual inspection with acetic acid were offered cryotherapy. Safety was determined by monitoring adverse events. Exit surveys assessed acceptability and feasibility. Feasibility was also assessed by measuring testing and triage throughputs. RESULTS: Technician training required 2.5 days to achieve competency. A total of 431 women were screened in 14 days, with an average of 31 women screened daily. No adverse events were reported. Women deemed the program overwhelmingly acceptable: 90.5% reported that they would take the self-swab again, 71.3% preferred the self-swab to a clinician swab. The program was also feasible: 99.8% of eligible women agreed to testing, 94.8% returned for same-day follow-up, and women only spent 30 to 50 minutes of their total time with the program from screening to results. CONCLUSIONS: Cervical cancer prevention programs based on self-swab HPV testing could be safe, acceptable, feasible, and effective at the community level in low-resource settings.
    Journal of Lower Genital Tract Disease 02/2013; DOI:10.1097/LGT.0b013e31826b7b70
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    ABSTRACT: Objective To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death Study Design This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. 153 women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 μg buccal misoprostol or 200 μg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention Results Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8% (47/76) of women receiving misoprostol 100 μg and 77.9% (60/77) of women receiving misoprostol 200 μg. The 200 μg dose was significantly more effective than the 100 μg dose at expelling the fetus and placenta within 48 h (RR 0.68 (95%CI: 0.50-0.92; p-value: 0.03)). The mean time to expulsion was significantly shorter using the 200 μg dose (18.5 h + 11.9 h) than the 100 μg dose (23.9 + 12.5 h) (p = 0.02). Most women in both groups found the procedure satisfactory or very satisfactory (Group 1: 76.7% (56/73); Group 2: 89.5% (68/76) (RR 0.86 (95%CI: 0.74-1.00)). Conclusion Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 μg dose is significantly more effective than 100 μg for evacuating the uterus within 48 h. The treatment is highly acceptable to women. Implications Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. Induction of labor to effect the delivery of a demised fetus at 14-28 weeks with 200 μg buccal misoprostol given every six hours is an effective approach that can be implemented in a wide variety of settings.
    Contraception 01/2013; 89(3). DOI:10.1016/j.contraception.2013.11.014
  • American Journal of Obstetrics and Gynecology 01/2013; 208(1):S62-S63. DOI:10.1016/j.ajog.2012.10.282
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    ABSTRACT: BACKGROUND: Contraception in many developing countries is characterized by high unmet need, irregular access, low utilization and presumed demand for long-acting reversible contraceptives (LARCs). STUDY DESIGN: A 13-country initiative focused on increasing consumer demand and high quality services for intrauterine devices (IUDs) began in 2009. Services were provided through (a) private sector-franchised or affiliated clinics; (b) providers seconded to the public sector and (c) special "event" days. Client intake data are used to compare the profile of IUD acceptors with IUD users from representative national datasets of select countries, as well as examine trends in IUD uptake. RESULTS: During 2009-2010, 575,601 IUDs were inserted across the 13 countries. Compared to national IUD users, users in this project were slightly younger and less educated. Among IUD acceptors, 24% used no modern method at the time of IUD initiation, and 28% reported injectable use in the three previous months. CONCLUSIONS: Convenient, quality, affordable services with demand creation can result in significant uptake of LARCs in settings with low use.
    Contraception 11/2012; 87(2). DOI:10.1016/j.contraception.2012.10.002
  • L. Trope, P.D. Blumenthal, B. Chumworathayi
    International Journal of Gynecology & Obstetrics 10/2012; 119:S299. DOI:10.1016/S0020-7292(12)60540-2
  • P. Blumenthal, S. Prager, E. Espey
    International Journal of Gynecology & Obstetrics 10/2012; 119:S172–S173. DOI:10.1016/S0020-7292(12)60078-2
  • P. Blumenthal
    International Journal of Gynecology & Obstetrics 10/2012; 119:S173. DOI:10.1016/S0020-7292(12)60080-0
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    ABSTRACT: This qualitative study aimed to assess factors influencing pregnant women's decision to seek or avoid antenatal care (ANC) in the Andes of Peru. Open-ended, semi-structured interviews were conducted with 24 women utilizing ANC (+) and 10 women avoiding ANC (-). Interviews were translated to English from Quechua and Spanish, transcribed, and analyzed using grounded theory. Factors influencing ANC- women included: expecting criticism for having additional children; long ANC wait time and inconvenient hours of operation; and masculine gender of health workers. For ANC+ women, motivating factors included: maximizing positive health outcomes; past negative maternity experiences; pressure from family members; and avoidance of rumored fines or fees associated with ANC non-attendance and in-hospital deliveries, respectively. Both ANC+ and ANC- women were fearful and embarrassed about possible criticism for having additional children and the gender of the health workers, yet they weighed these factors differently. To better understand how rural women make decisions about ANC attendance, it is important to consider the value they place on the factors influencing their decision, and their emotional assessment of such issues.
    Maternal and Child Health Journal 08/2012; 17(6). DOI:10.1007/s10995-012-1113-9
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    ABSTRACT: BACKGROUND: Medical abortion in the United States requires clinic-based follow-up, representing additional time and cost to women and clinics. We studied a semi-quantitative home pregnancy test as a possible replacement for in-person follow-up. STUDY DESIGN: Four hundred and ninety women participated in the clinical study and used a pregnancy test to determine baseline human chorionic gonadotropin (hCG) on the day of mifepristone administration and follow-up hCG 1 week later. One hundred and eighty-nine other women completed a user comprehension survey. Accuracy, feasibility and acceptability of the test were assessed in both the clinical study and the survey. RESULTS: The test identified the one ongoing pregnancy in the clinical study cohort. Sensitivity and specificity were calculated at 100.0% and 97.0%. The majority of participants in both the clinical study and the user comprehension survey found the test to be "very easy" or "easy" to use. CONCLUSION: At-home follow-up with a semi-quantitative pregnancy test is feasible for service delivery in the United States.
    Contraception 08/2012; 86(6). DOI:10.1016/j.contraception.2012.06.005
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    ABSTRACT: In 2008, cervical cancer was responsible for 275000 deaths, of which approximately 88% occurred in low- and middle-income countries. In 2009, the World Health Organization (WHO) committed to updating recommendations for use of cryotherapy for cervical intraepithelial neoplasia (CIN). We followed the WHO Handbook for Guidelines Development to develop present guidelines. An expert panel was established, which included clinicians, researchers, program directors, and methodologists. An independent group conducted systematic reviews and produced evidence summaries following the GRADE approach. GRADE evidence profiles were created for 16 key questions about the effects of cryotherapy in the presence of histologically confirmed CIN compared with no treatment and with loop electrosurgical excision procedure, as well as the use of different cryotherapy techniques. We identified a small number of randomized controlled trials or independently controlled observational studies. Surrogate outcomes were reported when evidence about outcomes critical to decision making were not available. The panel made 14 recommendations and documented factors that determined the strength and direction of the recommendations in decision tables. The present document summarizes new evidence-based WHO recommendations about the use of cryotherapy in women with histologically confirmed CIN for low-, middle-, and high-income countries.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 06/2012; 118(2):97-102. DOI:10.1016/j.ijgo.2012.01.029

Publication Stats

3k Citations
685.34 Total Impact Points

Institutions

  • 2008–2015
    • Stanford University
      • • Department of Obstetrics and Gynecology
      • • Department of Medicine
      Palo Alto, California, United States
  • 2008–2014
    • Stanford Medicine
      • Department of Obstetrics and Gynecology
      Stanford, California, United States
  • 2013
    • Khon Kaen University
      Kawn Ken, Khon Kaen, Thailand
  • 2012
    • Population Services International
      Washington, Washington, D.C., United States
  • 2007
    • Jhpiego
      Baltimore, Maryland, United States
  • 1994–2007
    • Johns Hopkins University
      • • Department of Gynecology & Obstetrics
      • • Department of Medicine
      Baltimore, Maryland, United States
  • 2006
    • Cerner Corporation
      Kansas City, Missouri, United States
  • 1995–2006
    • Johns Hopkins Medicine
      • Department of Gynecology & Obstetrics
      Baltimore, Maryland, United States
  • 2002–2003
    • University of Maryland, Baltimore
      Baltimore, Maryland, United States
    • Georgetown University
      • Department of Oncology
      Washington, D. C., DC, United States
  • 1988
    • Saint Michael's Medical Center
      Newark, New Jersey, United States