Hany Abdel-aleem | Assiut University (original) (raw)

Papers by Hany Abdel-aleem

Countries ethics committees list and status of the project approval request. (DOCX 15 kb)

Rationale for the choice of the non-inferiority trial the choice of the non-inferiority trial [20... more Rationale for the choice of the non-inferiority trial the choice of the non-inferiority trial [20-22]. (DOCX 24 kb)

(88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the... more (88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the two groups in the number of breastfeeding episodes, time of weaning, and the cumulative rates of full and partial breastfeeding. There were no significant differences be- tween the two groups in infant weight, weight gain per day, or in infant linear growth. There were no significant differ- ences in the incidence of important health problems affect- ing the infants of the two groups. However, there were seven infant deaths, six of them were in the Uniplant group.

International Journal of Gynecology & Obstetrics

Abstract OBJECTIVE: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding t... more Abstract OBJECTIVE: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in cases of intrapartum fetal distress. METHODS: A randomized clinical trial including 438 women admitted in labor at Assiut University Hospital with nonreassuring fetal heart rate tracing. Using sealed opaque envelopes, the women were randomized to 2 groups. In the amnioinfusion group they underwent transcervical amnioinfusion (1000 mL of warmed sterile saline solution) in addition to conventional treatment. In the control group they received conventional treatment only. The primary outcome was cesarean section rate for fetal distress. The secondary outcomes were neonatal and maternal complications. RESULTS: The amnioinfusion group showed a significant reduction in the rate of cesarean section for fetal distress (relative risk [RR], 0.7; 95% confidence interval [CI], 0.6-0.83), and a 30% reduction in abnormal fetal heart rate patterns (RR, 0.7; 95% CI, 0.6-0.83). Significantly fewer...

Obstetrical & Gynecological Survey, 2012

International Journal of Gynecology & Obstetrics, 2005

Objective: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in ca... more Objective: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in cases of intrapartum fetal distress. Methods: A randomized clinical trial including 438 women admitted in labor at Assiut University Hospital with nonreassuring fetal heart rate tracing. Using sealed opaque envelopes, the women were randomized to 2 groups. In the amnioinfusion group they underwent transcervical amnioifusion (1000 mL of warmed sterile saline solution) in addition to conventional treatment. In the control group they received conventional treatment only. The primary outcome was cesarean section rate for fetal distress. The secondary outcomes were neonatal and maternal complications. Results: The amnioinfusion group showed a significant reduction in the rate of cesarean section for fetal distress (relative risk [RR], 0.7; 95% confidence interval [CI], 0.6-0.83), and a 30% reduction in abnormal fetal heart rate patterns (RR, 0.7; 95% CI, 0.6-0.83). Significantly fewer newborns had Apgar scores less than 7 at 1 and 5 min in the amnioinfusion group than in the control group (RR, 0.38; 95% CI, 0.26-0.55 and RR, 0.31; 95% CI, 0.15-0.64, respectively). Significantly fewer newborns had meconium below the vocal cords in the amnioinfusion group than in the control group (RR, 0.36; 95% CI, 0.13-0.97). Moreover, 14 newborns in the amnioinfusion group needed admission to the intensive care unit vs. 31 newborns in the control group. There were no significant differences between the 2 groups regarding the incidence rates of uterine hypertonus and maternal temperature higher than 38 8C. Conclusion: Therapeutic amnioinfusion is a simple and effective intervention that reduces the rates of cesarean section for intrapartum nonreassuring fetal heart tracing. In underresourced settings, it can be performed using inexpensive catheters.

American Journal of Obstetrics and Gynecology, 2005

OBJECTIVE: To measure whether knowledge of fetal oxygen saturation, as an adjunct to continuous e... more OBJECTIVE: To measure whether knowledge of fetal oxygen saturation, as an adjunct to continuous electronic fetal monitoring, (1) is associated with a significant change in the overall rate of cesarean delivery, including those performed specifically for non-reassuring fetal heart rate pattern and dystocia, and (2) is related to infant condition at birth. STUDY DESIGN: 5341 nulliparous women at term in early labor were randomly assigned to ''open'' or ''masked'' fetal pulse oximetry. In the ''open'' arm, fetal oxygen saturation values were displayed to the clinician. In the ''masked'' group, the fetal oxygen sensor was inserted and the values recorded by computer, but the data were hidden. Labors complicated by a nonreassuring fetal heart rate pattern prior to randomization were documented for subsequent analysis. The trial was stopped before the final sample size of 10,000 because the overall cesarean rate (primary outcome) in the masked arm was higher than expected, and there was O90% power to detect the prespecified 15% reduction in the open arm.

American Journal of Obstetrics and Gynecology, 2006

The purpose of this trial was to determine whether calcium supplementation of pregnant women with... more The purpose of this trial was to determine whether calcium supplementation of pregnant women with low calcium intake reduces preeclampsia and preterm delivery. Study design: Randomized placebo-controlled, double-blinded trial in nulliparous normotensive women from populations with dietary calcium !600 mg/d. Women who were recruited before gestational week 20 received supplements (1.5 g calcium/d or placebo) throughout pregnancy.

American Journal of Obstetrics and Gynecology, 2007

Trials, Jan 17, 2016

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries a... more Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth. Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intra...

About 50% of complainers had top-fundal distance more than 4 mm, compared to 28% of non-complaine... more About 50% of complainers had top-fundal distance more than 4 mm, compared to 28% of non-complainers. An intercornual diameter, too small (~30 mm) or too wide (~38 mm), was significantly more frequent in women complaining of bleeding and pain. Other abnormal findings were diagnosed in 25% of complainers compared to 7% in those without complaint. These findings included partial expulsion, appearance suggestive of pelvic inflammatory disease, ovarian swellings, embedding and fibroid uterus.

Journal of Current Medical Research and Practice

BJOG : an international journal of obstetrics and gynaecology, Jan 7, 2017

The first cause of maternal death worldwide is postpartum hemorrhage (PPH), responsible for an es... more The first cause of maternal death worldwide is postpartum hemorrhage (PPH), responsible for an estimated 127,000 deaths annually. Failure of the uterus to contract adequately after childbirth is the most common cause of PPH. In the absence of timely and appropriate action, a woman could die within a few hours. This article is protected by copyright. All rights reserved.

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2017

To assess use of the C-Model in a tertiary hospital setting in terms of its validity and utility ... more To assess use of the C-Model in a tertiary hospital setting in terms of its validity and utility for optimizing the cesarean delivery (CD) rate. A prospective observational study included women admitted for delivery at a university teaching hospital in Assiut, Egypt, in 2015. The women were asked about the demographic and obstetric information needed to calculate the probability of CD using the WHO C-Model. A receiver operating characteristic (ROC) curve comparing the predicted and observed CD rates was constructed. In addition, the mean predicted CD rates were compared with the mean observed CD rates in the 10 groups of the Robson classification. In total, 1000 women were recruited; 38.6% had a previous CD and 13.5% had complications during the current pregnancy. The final mode of delivery was vaginal delivery in 38.7% and CD in 61.3%; the predicted CD rate for this cohort was 45.0%. The area under the ROC curve was 0.928 (95% confidence interval 0.912-0.945). Comparison of the pre...

PLoS medicine, 2017

Background Perinatal mortality and morbidity continue to be major global health challenges strong... more Background Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use.

PLoS medicine, 2017

Perinatal mortality and morbidity continue to be major global health challenges strongly associat... more Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use. We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth. Centers in ten countries (Argentina, Brazil, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand) recruited participants who had reliable information on last menstrual period and gestational age confirmed by crow...

The New England journal of medicine, Aug 27, 2018

Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the stan... more Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. Methods We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. Results A total of 29,645...

Countries ethics committees list and status of the project approval request. (DOCX 15 kb)

Rationale for the choice of the non-inferiority trial the choice of the non-inferiority trial [20... more Rationale for the choice of the non-inferiority trial the choice of the non-inferiority trial [20-22]. (DOCX 24 kb)

(88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the... more (88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the two groups in the number of breastfeeding episodes, time of weaning, and the cumulative rates of full and partial breastfeeding. There were no significant differences be- tween the two groups in infant weight, weight gain per day, or in infant linear growth. There were no significant differ- ences in the incidence of important health problems affect- ing the infants of the two groups. However, there were seven infant deaths, six of them were in the Uniplant group.

International Journal of Gynecology & Obstetrics

Abstract OBJECTIVE: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding t... more Abstract OBJECTIVE: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in cases of intrapartum fetal distress. METHODS: A randomized clinical trial including 438 women admitted in labor at Assiut University Hospital with nonreassuring fetal heart rate tracing. Using sealed opaque envelopes, the women were randomized to 2 groups. In the amnioinfusion group they underwent transcervical amnioinfusion (1000 mL of warmed sterile saline solution) in addition to conventional treatment. In the control group they received conventional treatment only. The primary outcome was cesarean section rate for fetal distress. The secondary outcomes were neonatal and maternal complications. RESULTS: The amnioinfusion group showed a significant reduction in the rate of cesarean section for fetal distress (relative risk [RR], 0.7; 95% confidence interval [CI], 0.6-0.83), and a 30% reduction in abnormal fetal heart rate patterns (RR, 0.7; 95% CI, 0.6-0.83). Significantly fewer...

Obstetrical & Gynecological Survey, 2012

International Journal of Gynecology & Obstetrics, 2005

Objective: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in ca... more Objective: To evaluate the role of therapeutic amnioinfusion using a pediatric feeding tube in cases of intrapartum fetal distress. Methods: A randomized clinical trial including 438 women admitted in labor at Assiut University Hospital with nonreassuring fetal heart rate tracing. Using sealed opaque envelopes, the women were randomized to 2 groups. In the amnioinfusion group they underwent transcervical amnioifusion (1000 mL of warmed sterile saline solution) in addition to conventional treatment. In the control group they received conventional treatment only. The primary outcome was cesarean section rate for fetal distress. The secondary outcomes were neonatal and maternal complications. Results: The amnioinfusion group showed a significant reduction in the rate of cesarean section for fetal distress (relative risk [RR], 0.7; 95% confidence interval [CI], 0.6-0.83), and a 30% reduction in abnormal fetal heart rate patterns (RR, 0.7; 95% CI, 0.6-0.83). Significantly fewer newborns had Apgar scores less than 7 at 1 and 5 min in the amnioinfusion group than in the control group (RR, 0.38; 95% CI, 0.26-0.55 and RR, 0.31; 95% CI, 0.15-0.64, respectively). Significantly fewer newborns had meconium below the vocal cords in the amnioinfusion group than in the control group (RR, 0.36; 95% CI, 0.13-0.97). Moreover, 14 newborns in the amnioinfusion group needed admission to the intensive care unit vs. 31 newborns in the control group. There were no significant differences between the 2 groups regarding the incidence rates of uterine hypertonus and maternal temperature higher than 38 8C. Conclusion: Therapeutic amnioinfusion is a simple and effective intervention that reduces the rates of cesarean section for intrapartum nonreassuring fetal heart tracing. In underresourced settings, it can be performed using inexpensive catheters.

American Journal of Obstetrics and Gynecology, 2005

OBJECTIVE: To measure whether knowledge of fetal oxygen saturation, as an adjunct to continuous e... more OBJECTIVE: To measure whether knowledge of fetal oxygen saturation, as an adjunct to continuous electronic fetal monitoring, (1) is associated with a significant change in the overall rate of cesarean delivery, including those performed specifically for non-reassuring fetal heart rate pattern and dystocia, and (2) is related to infant condition at birth. STUDY DESIGN: 5341 nulliparous women at term in early labor were randomly assigned to ''open'' or ''masked'' fetal pulse oximetry. In the ''open'' arm, fetal oxygen saturation values were displayed to the clinician. In the ''masked'' group, the fetal oxygen sensor was inserted and the values recorded by computer, but the data were hidden. Labors complicated by a nonreassuring fetal heart rate pattern prior to randomization were documented for subsequent analysis. The trial was stopped before the final sample size of 10,000 because the overall cesarean rate (primary outcome) in the masked arm was higher than expected, and there was O90% power to detect the prespecified 15% reduction in the open arm.

American Journal of Obstetrics and Gynecology, 2006

The purpose of this trial was to determine whether calcium supplementation of pregnant women with... more The purpose of this trial was to determine whether calcium supplementation of pregnant women with low calcium intake reduces preeclampsia and preterm delivery. Study design: Randomized placebo-controlled, double-blinded trial in nulliparous normotensive women from populations with dietary calcium !600 mg/d. Women who were recruited before gestational week 20 received supplements (1.5 g calcium/d or placebo) throughout pregnancy.

American Journal of Obstetrics and Gynecology, 2007

Trials, Jan 17, 2016

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries a... more Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth. Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intra...

About 50% of complainers had top-fundal distance more than 4 mm, compared to 28% of non-complaine... more About 50% of complainers had top-fundal distance more than 4 mm, compared to 28% of non-complainers. An intercornual diameter, too small (~30 mm) or too wide (~38 mm), was significantly more frequent in women complaining of bleeding and pain. Other abnormal findings were diagnosed in 25% of complainers compared to 7% in those without complaint. These findings included partial expulsion, appearance suggestive of pelvic inflammatory disease, ovarian swellings, embedding and fibroid uterus.

Journal of Current Medical Research and Practice

BJOG : an international journal of obstetrics and gynaecology, Jan 7, 2017

The first cause of maternal death worldwide is postpartum hemorrhage (PPH), responsible for an es... more The first cause of maternal death worldwide is postpartum hemorrhage (PPH), responsible for an estimated 127,000 deaths annually. Failure of the uterus to contract adequately after childbirth is the most common cause of PPH. In the absence of timely and appropriate action, a woman could die within a few hours. This article is protected by copyright. All rights reserved.

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2017

To assess use of the C-Model in a tertiary hospital setting in terms of its validity and utility ... more To assess use of the C-Model in a tertiary hospital setting in terms of its validity and utility for optimizing the cesarean delivery (CD) rate. A prospective observational study included women admitted for delivery at a university teaching hospital in Assiut, Egypt, in 2015. The women were asked about the demographic and obstetric information needed to calculate the probability of CD using the WHO C-Model. A receiver operating characteristic (ROC) curve comparing the predicted and observed CD rates was constructed. In addition, the mean predicted CD rates were compared with the mean observed CD rates in the 10 groups of the Robson classification. In total, 1000 women were recruited; 38.6% had a previous CD and 13.5% had complications during the current pregnancy. The final mode of delivery was vaginal delivery in 38.7% and CD in 61.3%; the predicted CD rate for this cohort was 45.0%. The area under the ROC curve was 0.928 (95% confidence interval 0.912-0.945). Comparison of the pre...

PLoS medicine, 2017

Background Perinatal mortality and morbidity continue to be major global health challenges strong... more Background Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use.

PLoS medicine, 2017

Perinatal mortality and morbidity continue to be major global health challenges strongly associat... more Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use. We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth. Centers in ten countries (Argentina, Brazil, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand) recruited participants who had reliable information on last menstrual period and gestational age confirmed by crow...

The New England journal of medicine, Aug 27, 2018

Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the stan... more Background Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin. Methods We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 μg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary outcomes: the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively. Results A total of 29,645...