A Phase 3 interventional study of Misoprostol in Postpartum Hemorrhage, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Assiut University · Phase 3, Interventional, and Prevention
Cesarean section (CS) is one of the most frequently performed operative interventions worldwide [1]. Cesarean section rates increase each year throughout the world. Cesarean delivery can lead to some serious maternal and fetal complications [2] including primary postpartum hemorrhage (PPH). Primary PPH is defined as a blood loss of more than 1000 ml during the first 24 hours after delivery [3], and it is the most common cause of maternal mortality worldwide [4]. Misoprostol is a synthetic prostaglandin E1 analog, commonly used for the prevention and management of PPH. It has potent uterotonic properties and fewer side effects at therapeutic doses [5]; it is absorbed orally, vaginally and across the mucous membranes of the rectum and oral cavity [6] [7] [8]. Misoprostol is affordable, widely available, and easily administrated via multiple routes, and has a good safety profile if properly administrated and monitored, all of which might make it the standard treatment option for PPH in low-resource settings [9]. The benefits (cervical dilatation and uterine contractions) and the adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose-dependent [10]. Hofmeyr et al. studied the pharmacokinetics of misoprostol administered by various routes. According to this study, the oral route has the most rapid uptake, but the shortest duration. The rectal route has slow uptake but prolonged duration. The buccal and sublingual routes have rapid uptake, prolonged duration and greatest total bioavailability [11]. Besides that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage [12] [13]. Also, in cases with retained placenta, it may have a role in the management of associated bleeding which mostly results from atony [14] [15]. In the field of gynecology, misoprostol could be used for induction of cervical ripening before office gynecological procedures [16] [17] [18]. This could decrease the associated pain induced by transcervical passage of instruments. Intraoperative blood loss is one of the important complications during CS. In 2011, a systematic review that included twenty-one studies revealed that there is an increased incidence of intraoperative blood loss and blood transfusion with an increased number of cesarean deliveries [19]. Previous reports have shown that misoprostol is effective in reducing blood loss during and after cesarean delivery regardless of route of administration [20] . However, the optimum time for administration of misoprostol to decrease the amount of PPH is still under discussion. A. E. A. Youssef et al. DOI: 10.4236/ojog.2019.94052 531 Open Journal of Obstetrics and Gynecology Therefore the current study aims to compare the effect of preoperative vaginal and postoperative sublingual administration of misoprostol (800 μg) in reducing the amount of blood loss during and 24 hours after CS.
Cesarean section (CS) is one of the most frequently performed operative interventions worldwide [1]. Cesarean section rates increase each year throughout the world. Cesarean delivery can lead to some serious maternal and fetal complications [2] including primary postpartum hemorrhage (PPH). Primary PPH is defined as a blood loss of more than 1000 ml during the first 24 hours after delivery [3], and it is the most common cause of maternal mortality worldwide [4]. Misoprostol is a synthetic prostaglandin E1 analog, commonly used for the prevention and management of PPH. It has potent uterotonic properties and fewer side effects at therapeutic doses [5]; it is absorbed orally, vaginally and across the mucous membranes of the rectum and oral cavity [6] [7] [8]. Misoprostol is affordable, widely available, and easily administrated via multiple routes, and has a good safety profile if properly administrated and monitored, all of which might make it the standard treatment option for PPH in low-resource settings [9]. The benefits (cervical dilatation and uterine contractions) and the adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose-dependent [10]. Hofmeyr et al. studied the pharmacokinetics of misoprostol administered by various routes. According to this study, the oral route has the most rapid uptake, but the shortest duration. The rectal route has slow uptake but prolonged duration. The buccal and sublingual routes have rapid uptake, prolonged duration and greatest total bioavailability [11]. Besides that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage [12] [13]. Also, in cases with retained placenta, it may have a role in the management of associated bleeding which mostly results from atony [14] [15]. In the field of gynecology, misoprostol could be used for induction of cervical ripening before office gynecological procedures [16] [17] [18]. This could decrease the associated pain induced by transcervical passage of instruments. Intraoperative blood loss is one of the important complications during
Cesarean section (CS) is one of the most frequently performed operative interventions worldwide [1]. Cesarean section rates increase each year throughout the world. Cesarean delivery can lead to some serious maternal and fetal complications [2] including primary postpartum hemorrhage (PPH). Primary PPH is defined as a blood loss of more than 1000 ml during the first 24 hours after delivery [3], and it is the most common cause of maternal mortality worldwide [4]. Misoprostol is a synthetic prostaglandin E1 analog, commonly used for the prevention and management of PPH. It has potent uterotonic properties and fewer side effects at therapeutic doses [5]; it is absorbed orally, vaginally and across the mucous membranes of the rectum and oral cavity [6] [7] [8]. Misoprostol is affordable, widely available, and easily administrated via multiple routes, and has a good safety profile if properly administrated and monitored, all of which might make it the standard treatment option for PPH in low-resource settings [9]. The benefits (cervical dilatation and uterine contractions) and the adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose-dependent [10]. Hofmeyr et al. studied the pharmacokinetics of misoprostol administered by various routes. According to this study, the oral route has the most rapid uptake, but the shortest duration. The rectal route has slow uptake but prolonged duration. The buccal and sublingual routes have rapid uptake, prolonged duration and greatest total bioavailability [11]. Besides that, it can be used for termination of pregnancy in cases of missed or incomplete miscarriage [12] [13]. Also, in cases with retained placenta, it may have a role in the management of associated bleeding which mostly results from atony [14] [15]. In the field of gynecology, misoprostol could be used for induction of cervical ripening before office gynecological procedures [16] [17] [18]. This could decrease the associated pain induced by transcervical passage of instruments. Intraoperative blood loss is one of the important complications during CS. In 2011, a systematic review that included twenty-one studies revealed that there is an increased incidence of intraoperative blood loss and blood transfusion with an increased number of cesarean deliveries [19]. Previous reports have shown that misoprostol is effective in reducing blood loss during and after cesarean delivery regardless of route of administration [20] . However, the optimum time for administration of misoprostol to decrease the amount of PPH is still under discussion. A. E. A. Youssef et al. DOI: 10.4236/ojog.2019.94052 531 Open Journal of Obstetrics and Gynecology Therefore the current study aims to compare the effect of preoperative vaginal and postoperative sublingual administration of misoprostol (800 μg) in reducing the amount of blood loss during and 24 hours after CS.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's planned enrollment of 400 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
women who will undergo elective lower segment CS at term (≥37 weeks) with normal fetal heart tracing
Drug: Misoprostol
preoperative vaginal and postoperative sublingual administration of misoprostol (800 μg) to reducing the amount of blood loss during and 24 hours after CS to determine the optimum time for drug administration.
the amount of blood loss
the amount of blood loss during and 24 hours after CS
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
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Assiut University