Suellen Miller | University of California, San Francisco (original) (raw)

Papers by Suellen Miller

Research paper thumbnail of Having A “Safe Delivery”: Conflicting Views from Tibet

Health Care for Women International, 2005

Using ethnographic methods, we gathered data from individual interviews with rural Tibetan women ... more Using ethnographic methods, we gathered data from individual interviews with rural Tibetan women (N = 38) about their beliefs and behaviors surrounding pregnancy and childbirth. Additional data were gathered through interviews with prefecture, county, and township health care providers. These data were used to develop a culturally appropriate village birth attendant training program in rural Tibet. We describe Tibetan women's perspectives of "having a safe delivery" in relation to concepts about "safe delivery" according to evidence-based medicine in the West. Our work also provides an example of the benefits and challenges that arise when ethnographic research methods are used to design and implement health care interventions.

Research paper thumbnail of Beyond Too Little Too Late, Too Much Too Soon

On the continuum of maternal health care, two extreme situations exist: too little, too late (TLT... more On the continuum of maternal health care, two extreme situations exist: too little, too late (TLTL) and too much, too soon (TMTS). TLTL describes care with inadequate resources, below evidence-based standards, or care withheld or unavailable until too late to help. TLTL is an underlying problem associated with high maternal mortality and morbidity. TMTS describes the routine over-medicalisation of normal pregnancy and birth. TMTS includes unnecessary use of non-evidence-based interventions, as well as use of interventions that can be life saving when used appropriately, but harmful when applied routinely or overused. As facility births increase, so does the recognition that TMTS causes harm and increases health costs, and often concentrates disrespect and abuse. Although TMTS is typically ascribed to high-income countries and TLTL to low-income and middle-income ones, social and health inequities mean these extremes coexist in many countries. A global approach to quality and equitable maternal health, supporting the implementation of respectful, evidence-based care for all, is urgently needed. We present a systematic review of evidence-based clinical practice guidelines for routine antenatal, intrapartum, and postnatal care, categorising them as recommended, recommended only for clinical indications, and not recommended. We also present prevalence data from middle-income countries for specific clinical practices, which demonstrate TLTL and increasing TMTS. Health-care providers and health systems need to ensure that all women receive high-quality, evidence-based, equitable and respectful care. The right amount of care needs to be offered at the right time, and delivered in a manner that respects, protects, and promotes human rights.

Research paper thumbnail of How to make consent informed: possible lessons from Tibet

IRB

The informed consent process is an essential com-ponent of ethical clinical research.' D... more The informed consent process is an essential com-ponent of ethical clinical research.' Despite the growing emphasis on the use of simple, nontech-nical language and clear explanations,2 researchers and ethicists are concerned that many individuals, even in ...

Research paper thumbnail of Misoprostol and declining abortion-related morbidity in Santo Domingo, Dominican Republic: a temporal association

BJOG: An International Journal of Obstetrics & Gynaecology, 2005

Objective To validate anecdotal reports that abortion-related complications decreased in the Domi... more Objective To validate anecdotal reports that abortion-related complications decreased in the Dominican Republic after the introduction of misoprostol into the country. Design Retrospective records reviews and cross-sectional surveys, interviews and focus groups.

Research paper thumbnail of O421 Non-Pneumatic Anti-Shock Garment (Nasg) for Obstetric Hemorrhage: Harare, Zimbabwe

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O122 Comparing Transport Type for Women With Hypovolemic Shock in Early vs. Late Pregnancy

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O666 Cost Effectiveness of Non-Pneumatic Anti-Shock Garment (Nasg) for Obstetric Hemorrhage

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O123 Challenges: Cluster Randomized Trial (CRT) of the Non-Pneumatic Anti-Shock Garment (Nasg)

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of Nonatonic Obstetric Haemorrhage: Effectiveness of the Nonpneumatic Antishock Garment in Egypt

ISRN Obstetrics and Gynecology, 2011

The study aims to determine if the nonpneumatic antishock garment (NASG), a first aid compression... more The study aims to determine if the nonpneumatic antishock garment (NASG), a first aid compression device, decreases severe adverse outcomes from nonatonic obstetric haemorrhage. Women with nonatonic aetiologies (434), blood loss > 1000 mL, and signs of shock were eligible. Women received standard care during the preintervention phase (226) and standard care plus application of the garment in the NASG phase (208). Blood loss and extreme adverse outcomes (EAO-mortality and severe morbidity) were measured. Women who used the NASG had more estimated blood loss on admission. Mean measured blood loss was 370 mL in the preintervention phase and 258 mL in the NASG phase (P < 0.0001). EAO decreased with use of the garment (2.9% versus 4.4%, (OR 0.65, 95% CI 0.24-1.76)). In conclusion, using the NASG improved maternal outcomes despite the worse condition on study entry. These findings should be tested in larger studies.

Research paper thumbnail of Positive Effects of the Non-pneumatic Anti-shock Garment on Delays in Accessing Care for Postpartum and Postabortion Hemorrhage in Egypt and Nigeria

Journal of Women's Health, 2011

Background: We examined whether the non-pneumatic anti-shock garment (NASG) ameliorates the effec... more Background: We examined whether the non-pneumatic anti-shock garment (NASG) ameliorates the effects of delays in transport to and treatment at hospitals for women with postpartum hemorrhage (PPH) and postabortion hemorrhage (PAH) and investigated the effects of NASG use on timing of delivery of interventions inhospital. Methods: Pre=post studies of the NASG were conducted at hospitals in Cairo (n ¼ 349 women), Assuit (n ¼ 274), Southern Nigeria (n ¼ 57), and Northern Nigeria (n ¼ 124). In post-hoc analyses, comparisons of delays were conducted using analysis of variance (ANOVA), and associations of delays with extreme adverse outcomes (EAO, mortality or severe morbidity) were examined using chi-square tests, odds ratios (ORs), and multivariate logistic regression. Results: Median minutes from hemorrhage start to study admission differed by site, ranging from 15 minutes in Cairo to 225 minutes in Northern Nigeria ( p < 0.001). Median minutes from study admission to blood transfusion ranged from 30 minutes in Cairo to 209 minutes in Southern Nigeria ( p < 0.001). Twenty percent of women with !60 minutes between hemorrhage start and study admission experienced an EAO without the NASG compared with only 6% with the NASG (w 2 ¼ 13.71, p < 0.001). In-hospital delays in receiving intravenous (IV) fluids and blood were more common in the NASG phase. Conclusions: Women with PPH or PAH in Egypt and Nigeria often face delays in reaching emergency obstetrical care facilities and delays in receiving definitive therapies after arrival. Our results indicate that the NASG can reduce the impact of these delays. Stabilization does not replace treatment, however, and delays in fluid=blood administration with NASG use must be avoided.

Research paper thumbnail of O636 The non-pneumatic anti-shock garment (NASG) for managing uterine atony and hypovolemic shock: Four Nigerian hospitals

International Journal of Gynecology & Obstetrics, 2009

The mid-urethral tension-free vaginal tape sling has emerged as the gold standard to treat female... more The mid-urethral tension-free vaginal tape sling has emerged as the gold standard to treat female stress urinary incontinence (SUI). The transobturator approach was then developed to reduce risks of retropubic needle passage. Most recently, the mini-sling has been developed in attempts to place the sling without any needle passages through the abdomen or groin. The current study was conducted to report on the technique, safety and early efficacy of a single-incision mini-sling to treat female SUI. Methods: Women suffering from SUI were offered a single-incision approach to place a sub-urethral polypropylene mesh tape in a position similar to that of a transobturator sling without passage of needles through the groins. Retrospective data was collected on the first 61 patients that underwent the new MiniArc (American Medical Systems, Minnetonka, MN) single-incision sling at our specialty center in the United States. All patients had urodynamic proven SUI. Patient selection and concomitant procedures were determined by the senior authors at the center. The senior authors (RDM, JRM) were the primary surgeons in all cases. Procedures were completed under general, regional, or MAC anesthesia as determined by the surgeon. Results: Sixty-one patients underwent the Mini-arc single incision sling. 92% of patients had concomitant procedures for prolapse during the same setting. Average age was 58 years (range 26-84) and average LPP was 71.3. Average operative time for the sling procedure alone was short and average blood loss was 29 cc. There were no intra-operative complications. There was one postoperative adverse event secondary to urinary retention which was resolved by loosening of the sling under local anesthesia in an office setting. Significant urge symptoms were present in 55% of patients pre-operatively and only 14% post-operative (75% resolution of urge symtpoms). Overall cure rate at 12 months determined by physician and patient assessment in 58/61 patients was 91.4%. No patients suffered pain or dyspareunia secondary to the sling and no erosions or extrusions were reported. Conclusions: In this initial study, the MiniArc single-incision sling appears to be a safe approach to treat female SUI and the early clinical results are encouraging with 12 month cure at 91.4%. A multicenter US prospective trial is on-going.

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG): When and where to apply

Objective: To use a comparative cost-effectiveness approach with evidence from four countries to ... more Objective: To use a comparative cost-effectiveness approach with evidence from four countries to understand which facility level is most appropriate for implementing the non-pneumatic anti-shock garment (NASG) to decrease maternal mortality associated with obstetric hemorrhage (OH). Methods: Two data sources were compared. We determined the cost-effectiveness of NASG application for women with hypovolemic shock from OH at the referral hospitals (RH) compared to standard of care within a two-phase intervention study of 6 RH in Egypt and Nigeria. To specify the cost-effectiveness of applying the NASG at the primary health clinic (PHC) level compared to the RH, we estimated random-effects models within a cluster-randomized control trial of 38 primary health clinics (PHC) in Zambia and Zimbabwe. Costs (blood transfusions, medications, etc.) and disability-adjusted life years (DALYs) were compared across the intervention scenarios. Results: The NASG was cost saving ($77-85 per woman in E...

Research paper thumbnail of Use of the Non-Pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage: A Cost-Effectiveness Analysis in Egypt and Nigeria

PLoS ONE, 2013

Objective: To assess the cost-effectiveness of a non-pneumatic anti-shock garment (NASG) for obst... more Objective: To assess the cost-effectiveness of a non-pneumatic anti-shock garment (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria.

Research paper thumbnail of Nurses in low resource settings save mothers' lives with non-pneumatic anti-shock garment

MCN. The American journal of maternal child nursing, 2012

To discuss the role of nurses and nurse-midwives in preventing and treating postpartum hemorrhage... more To discuss the role of nurses and nurse-midwives in preventing and treating postpartum hemorrhage (PPH) from uterine atony in developing countries and examine the role of a new device, the non-pneumatic anti-shock garment (NASG), in improving the outcomes for these patients. In this subanalysis of a larger preintervention phase/intervention phase study of 1,442 women with obstetric hemorrhage, postpartum women with hypovolemic shock (N = 578) from uterine atony (≥750 mL blood loss; systolic blood pressure <100 mmHg and/or pulse >100 beats per minute) were enrolled in two referral facilities in Egypt and four referral facilities in Nigeria. The study had two temporal phases: a preintervention phase and an NASG-intervention phase. Women with hemorrhage and shock in both phases were treated with the same evidence-based protocols for management of hypovolemic shock and hemorrhage, but women in the NASG-intervention phase also received the NASG. Relative risks (RRs) with 95% confid...

Research paper thumbnail of Miller S, Butrick E, Turan JM, Ojengbede OA, Morhason-Bello IO, Galadanci H, Martin H, Fabanwo A, Solanke O, Awwal M, Ojengbede A, Hensleigh P (2007). The Anti-Shock Garment for Postpartum Haemorrhage in Nigeria. Journal of Midwivery & Women’s Health; 52(5):534

Miller S, Butrick E, Turan JM, Ojengbede OA, Morhason-Bello IO, Galadanci H, Martin H, Fabanwo A, Solanke O, Awwal M, Ojengbede A, Hensleigh P (2007). The Anti-Shock Garment for Postpartum Haemorrhage in Nigeria. Journal of Midwivery & Women’s Health; 52(5):534

Journal of midwifery & women's health

Research paper thumbnail of O461 Non-Pneumatic Anti-Shock Garment (Nasg) Decreases Maternal Deaths in Lusaka, Zambia

International Journal of Gynecology & Obstetrics

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG) for obstetric hemorrhage: Cost savings and mortality reductions for women in severe shock

Objective: To assess the cost-effectiveness of non-pneumatic anti-shock garments (NASG) for obste... more Objective: To assess the cost-effectiveness of non-pneumatic anti-shock garments (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria. Methods: Results from published pre-intervention/NASG-intervention phase trials for women in severe shock (mean arterial pressure (MAP)<60) were standardized for 1,000 women. Clinical data included frequencies of health outcomes (mortality, major morbidity, severe anemia), and interventions to control bleeding (uterotonics, blood transfusions, hysterectomies). Costs (2010 international dollars) included the NASG, training, and clinical interventions. Changes in cost, morbidity, mortality, and disability-adjusted life years (DALYs) were used to calculate incremental cost-effectiveness ratios (ICERs; cost per DALY averted) for each country and study phase. We examined hysterectomies for all etiologies and for intractable uterine atony only. Results: Women with severe shock who received the NASG had lower mortality and morbidity...

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG) applied at the primary health clinic is associated with faster recovery from hypovolemic shock secondary to obstetric hemorrhage

Research paper thumbnail of Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol

Reproductive Health, 2015

Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women glob... more Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

Research paper thumbnail of Access to transport for women with hypovolemic shock differs according to weeks of pregnancy

International Journal of Gynecology & Obstetrics

Objective: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are ... more Objective: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are transported to referral hospitals differently depending on weeks of pregnancy in Zambia. Methods: In a retrospective study, transport type, wait time, and transit time were assessed for women with obstetric hemorrhage and hypovolemic shock transported from 26 primary health centers to three referral hospitals during 2007-2012. A mean arterial pressure of less than 60 mm Hg was used to indicate severe shock. Women were split into two categories on the basis of the number of weeks of pregnancy (<24 weeks vs 24 weeks). Results: Overall, 616 women were included. Mode of transport differed significantly by group (P < 0.001). 414 (93.0%) of 445 women at 24 weeks of pregnancy or more were transported by ambulance versus 114 (66.7%) of 171 women at less than 24 weeks. Among those in severe shock, 106 (93.0%) of 114 women at 24 weeks of pregnancy or more were transported in ambulances versu...

Research paper thumbnail of Having A “Safe Delivery”: Conflicting Views from Tibet

Health Care for Women International, 2005

Using ethnographic methods, we gathered data from individual interviews with rural Tibetan women ... more Using ethnographic methods, we gathered data from individual interviews with rural Tibetan women (N = 38) about their beliefs and behaviors surrounding pregnancy and childbirth. Additional data were gathered through interviews with prefecture, county, and township health care providers. These data were used to develop a culturally appropriate village birth attendant training program in rural Tibet. We describe Tibetan women's perspectives of "having a safe delivery" in relation to concepts about "safe delivery" according to evidence-based medicine in the West. Our work also provides an example of the benefits and challenges that arise when ethnographic research methods are used to design and implement health care interventions.

Research paper thumbnail of Beyond Too Little Too Late, Too Much Too Soon

On the continuum of maternal health care, two extreme situations exist: too little, too late (TLT... more On the continuum of maternal health care, two extreme situations exist: too little, too late (TLTL) and too much, too soon (TMTS). TLTL describes care with inadequate resources, below evidence-based standards, or care withheld or unavailable until too late to help. TLTL is an underlying problem associated with high maternal mortality and morbidity. TMTS describes the routine over-medicalisation of normal pregnancy and birth. TMTS includes unnecessary use of non-evidence-based interventions, as well as use of interventions that can be life saving when used appropriately, but harmful when applied routinely or overused. As facility births increase, so does the recognition that TMTS causes harm and increases health costs, and often concentrates disrespect and abuse. Although TMTS is typically ascribed to high-income countries and TLTL to low-income and middle-income ones, social and health inequities mean these extremes coexist in many countries. A global approach to quality and equitable maternal health, supporting the implementation of respectful, evidence-based care for all, is urgently needed. We present a systematic review of evidence-based clinical practice guidelines for routine antenatal, intrapartum, and postnatal care, categorising them as recommended, recommended only for clinical indications, and not recommended. We also present prevalence data from middle-income countries for specific clinical practices, which demonstrate TLTL and increasing TMTS. Health-care providers and health systems need to ensure that all women receive high-quality, evidence-based, equitable and respectful care. The right amount of care needs to be offered at the right time, and delivered in a manner that respects, protects, and promotes human rights.

Research paper thumbnail of How to make consent informed: possible lessons from Tibet

IRB

The informed consent process is an essential com-ponent of ethical clinical research.&#x27; D... more The informed consent process is an essential com-ponent of ethical clinical research.&#x27; Despite the growing emphasis on the use of simple, nontech-nical language and clear explanations,2 researchers and ethicists are concerned that many individuals, even in ...

Research paper thumbnail of Misoprostol and declining abortion-related morbidity in Santo Domingo, Dominican Republic: a temporal association

BJOG: An International Journal of Obstetrics & Gynaecology, 2005

Objective To validate anecdotal reports that abortion-related complications decreased in the Domi... more Objective To validate anecdotal reports that abortion-related complications decreased in the Dominican Republic after the introduction of misoprostol into the country. Design Retrospective records reviews and cross-sectional surveys, interviews and focus groups.

Research paper thumbnail of O421 Non-Pneumatic Anti-Shock Garment (Nasg) for Obstetric Hemorrhage: Harare, Zimbabwe

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O122 Comparing Transport Type for Women With Hypovolemic Shock in Early vs. Late Pregnancy

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O666 Cost Effectiveness of Non-Pneumatic Anti-Shock Garment (Nasg) for Obstetric Hemorrhage

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of O123 Challenges: Cluster Randomized Trial (CRT) of the Non-Pneumatic Anti-Shock Garment (Nasg)

International Journal of Gynecology & Obstetrics, 2012

Research paper thumbnail of Nonatonic Obstetric Haemorrhage: Effectiveness of the Nonpneumatic Antishock Garment in Egypt

ISRN Obstetrics and Gynecology, 2011

The study aims to determine if the nonpneumatic antishock garment (NASG), a first aid compression... more The study aims to determine if the nonpneumatic antishock garment (NASG), a first aid compression device, decreases severe adverse outcomes from nonatonic obstetric haemorrhage. Women with nonatonic aetiologies (434), blood loss > 1000 mL, and signs of shock were eligible. Women received standard care during the preintervention phase (226) and standard care plus application of the garment in the NASG phase (208). Blood loss and extreme adverse outcomes (EAO-mortality and severe morbidity) were measured. Women who used the NASG had more estimated blood loss on admission. Mean measured blood loss was 370 mL in the preintervention phase and 258 mL in the NASG phase (P < 0.0001). EAO decreased with use of the garment (2.9% versus 4.4%, (OR 0.65, 95% CI 0.24-1.76)). In conclusion, using the NASG improved maternal outcomes despite the worse condition on study entry. These findings should be tested in larger studies.

Research paper thumbnail of Positive Effects of the Non-pneumatic Anti-shock Garment on Delays in Accessing Care for Postpartum and Postabortion Hemorrhage in Egypt and Nigeria

Journal of Women's Health, 2011

Background: We examined whether the non-pneumatic anti-shock garment (NASG) ameliorates the effec... more Background: We examined whether the non-pneumatic anti-shock garment (NASG) ameliorates the effects of delays in transport to and treatment at hospitals for women with postpartum hemorrhage (PPH) and postabortion hemorrhage (PAH) and investigated the effects of NASG use on timing of delivery of interventions inhospital. Methods: Pre=post studies of the NASG were conducted at hospitals in Cairo (n ¼ 349 women), Assuit (n ¼ 274), Southern Nigeria (n ¼ 57), and Northern Nigeria (n ¼ 124). In post-hoc analyses, comparisons of delays were conducted using analysis of variance (ANOVA), and associations of delays with extreme adverse outcomes (EAO, mortality or severe morbidity) were examined using chi-square tests, odds ratios (ORs), and multivariate logistic regression. Results: Median minutes from hemorrhage start to study admission differed by site, ranging from 15 minutes in Cairo to 225 minutes in Northern Nigeria ( p < 0.001). Median minutes from study admission to blood transfusion ranged from 30 minutes in Cairo to 209 minutes in Southern Nigeria ( p < 0.001). Twenty percent of women with !60 minutes between hemorrhage start and study admission experienced an EAO without the NASG compared with only 6% with the NASG (w 2 ¼ 13.71, p < 0.001). In-hospital delays in receiving intravenous (IV) fluids and blood were more common in the NASG phase. Conclusions: Women with PPH or PAH in Egypt and Nigeria often face delays in reaching emergency obstetrical care facilities and delays in receiving definitive therapies after arrival. Our results indicate that the NASG can reduce the impact of these delays. Stabilization does not replace treatment, however, and delays in fluid=blood administration with NASG use must be avoided.

Research paper thumbnail of O636 The non-pneumatic anti-shock garment (NASG) for managing uterine atony and hypovolemic shock: Four Nigerian hospitals

International Journal of Gynecology & Obstetrics, 2009

The mid-urethral tension-free vaginal tape sling has emerged as the gold standard to treat female... more The mid-urethral tension-free vaginal tape sling has emerged as the gold standard to treat female stress urinary incontinence (SUI). The transobturator approach was then developed to reduce risks of retropubic needle passage. Most recently, the mini-sling has been developed in attempts to place the sling without any needle passages through the abdomen or groin. The current study was conducted to report on the technique, safety and early efficacy of a single-incision mini-sling to treat female SUI. Methods: Women suffering from SUI were offered a single-incision approach to place a sub-urethral polypropylene mesh tape in a position similar to that of a transobturator sling without passage of needles through the groins. Retrospective data was collected on the first 61 patients that underwent the new MiniArc (American Medical Systems, Minnetonka, MN) single-incision sling at our specialty center in the United States. All patients had urodynamic proven SUI. Patient selection and concomitant procedures were determined by the senior authors at the center. The senior authors (RDM, JRM) were the primary surgeons in all cases. Procedures were completed under general, regional, or MAC anesthesia as determined by the surgeon. Results: Sixty-one patients underwent the Mini-arc single incision sling. 92% of patients had concomitant procedures for prolapse during the same setting. Average age was 58 years (range 26-84) and average LPP was 71.3. Average operative time for the sling procedure alone was short and average blood loss was 29 cc. There were no intra-operative complications. There was one postoperative adverse event secondary to urinary retention which was resolved by loosening of the sling under local anesthesia in an office setting. Significant urge symptoms were present in 55% of patients pre-operatively and only 14% post-operative (75% resolution of urge symtpoms). Overall cure rate at 12 months determined by physician and patient assessment in 58/61 patients was 91.4%. No patients suffered pain or dyspareunia secondary to the sling and no erosions or extrusions were reported. Conclusions: In this initial study, the MiniArc single-incision sling appears to be a safe approach to treat female SUI and the early clinical results are encouraging with 12 month cure at 91.4%. A multicenter US prospective trial is on-going.

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG): When and where to apply

Objective: To use a comparative cost-effectiveness approach with evidence from four countries to ... more Objective: To use a comparative cost-effectiveness approach with evidence from four countries to understand which facility level is most appropriate for implementing the non-pneumatic anti-shock garment (NASG) to decrease maternal mortality associated with obstetric hemorrhage (OH). Methods: Two data sources were compared. We determined the cost-effectiveness of NASG application for women with hypovolemic shock from OH at the referral hospitals (RH) compared to standard of care within a two-phase intervention study of 6 RH in Egypt and Nigeria. To specify the cost-effectiveness of applying the NASG at the primary health clinic (PHC) level compared to the RH, we estimated random-effects models within a cluster-randomized control trial of 38 primary health clinics (PHC) in Zambia and Zimbabwe. Costs (blood transfusions, medications, etc.) and disability-adjusted life years (DALYs) were compared across the intervention scenarios. Results: The NASG was cost saving ($77-85 per woman in E...

Research paper thumbnail of Use of the Non-Pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage: A Cost-Effectiveness Analysis in Egypt and Nigeria

PLoS ONE, 2013

Objective: To assess the cost-effectiveness of a non-pneumatic anti-shock garment (NASG) for obst... more Objective: To assess the cost-effectiveness of a non-pneumatic anti-shock garment (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria.

Research paper thumbnail of Nurses in low resource settings save mothers' lives with non-pneumatic anti-shock garment

MCN. The American journal of maternal child nursing, 2012

To discuss the role of nurses and nurse-midwives in preventing and treating postpartum hemorrhage... more To discuss the role of nurses and nurse-midwives in preventing and treating postpartum hemorrhage (PPH) from uterine atony in developing countries and examine the role of a new device, the non-pneumatic anti-shock garment (NASG), in improving the outcomes for these patients. In this subanalysis of a larger preintervention phase/intervention phase study of 1,442 women with obstetric hemorrhage, postpartum women with hypovolemic shock (N = 578) from uterine atony (≥750 mL blood loss; systolic blood pressure <100 mmHg and/or pulse >100 beats per minute) were enrolled in two referral facilities in Egypt and four referral facilities in Nigeria. The study had two temporal phases: a preintervention phase and an NASG-intervention phase. Women with hemorrhage and shock in both phases were treated with the same evidence-based protocols for management of hypovolemic shock and hemorrhage, but women in the NASG-intervention phase also received the NASG. Relative risks (RRs) with 95% confid...

Research paper thumbnail of Miller S, Butrick E, Turan JM, Ojengbede OA, Morhason-Bello IO, Galadanci H, Martin H, Fabanwo A, Solanke O, Awwal M, Ojengbede A, Hensleigh P (2007). The Anti-Shock Garment for Postpartum Haemorrhage in Nigeria. Journal of Midwivery & Women’s Health; 52(5):534

Miller S, Butrick E, Turan JM, Ojengbede OA, Morhason-Bello IO, Galadanci H, Martin H, Fabanwo A, Solanke O, Awwal M, Ojengbede A, Hensleigh P (2007). The Anti-Shock Garment for Postpartum Haemorrhage in Nigeria. Journal of Midwivery & Women’s Health; 52(5):534

Journal of midwifery & women's health

Research paper thumbnail of O461 Non-Pneumatic Anti-Shock Garment (Nasg) Decreases Maternal Deaths in Lusaka, Zambia

International Journal of Gynecology & Obstetrics

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG) for obstetric hemorrhage: Cost savings and mortality reductions for women in severe shock

Objective: To assess the cost-effectiveness of non-pneumatic anti-shock garments (NASG) for obste... more Objective: To assess the cost-effectiveness of non-pneumatic anti-shock garments (NASG) for obstetric hemorrhage in tertiary hospitals in Egypt and Nigeria. Methods: Results from published pre-intervention/NASG-intervention phase trials for women in severe shock (mean arterial pressure (MAP)<60) were standardized for 1,000 women. Clinical data included frequencies of health outcomes (mortality, major morbidity, severe anemia), and interventions to control bleeding (uterotonics, blood transfusions, hysterectomies). Costs (2010 international dollars) included the NASG, training, and clinical interventions. Changes in cost, morbidity, mortality, and disability-adjusted life years (DALYs) were used to calculate incremental cost-effectiveness ratios (ICERs; cost per DALY averted) for each country and study phase. We examined hysterectomies for all etiologies and for intractable uterine atony only. Results: Women with severe shock who received the NASG had lower mortality and morbidity...

Research paper thumbnail of Non-pneumatic anti-shock garment (NASG) applied at the primary health clinic is associated with faster recovery from hypovolemic shock secondary to obstetric hemorrhage

Research paper thumbnail of Beyond repair - family and community reintegration after obstetric fistula surgery: study protocol

Reproductive Health, 2015

Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women glob... more Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.

Research paper thumbnail of Access to transport for women with hypovolemic shock differs according to weeks of pregnancy

International Journal of Gynecology & Obstetrics

Objective: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are ... more Objective: To examine whether women with hypovolemic shock secondary to obstetric hemorrhage are transported to referral hospitals differently depending on weeks of pregnancy in Zambia. Methods: In a retrospective study, transport type, wait time, and transit time were assessed for women with obstetric hemorrhage and hypovolemic shock transported from 26 primary health centers to three referral hospitals during 2007-2012. A mean arterial pressure of less than 60 mm Hg was used to indicate severe shock. Women were split into two categories on the basis of the number of weeks of pregnancy (<24 weeks vs 24 weeks). Results: Overall, 616 women were included. Mode of transport differed significantly by group (P < 0.001). 414 (93.0%) of 445 women at 24 weeks of pregnancy or more were transported by ambulance versus 114 (66.7%) of 171 women at less than 24 weeks. Among those in severe shock, 106 (93.0%) of 114 women at 24 weeks of pregnancy or more were transported in ambulances versu...