NCT06765473

Comparison Between Preoperative Vaginal and Postoperative Sublingual Misoprostol for Prevention of Postpartum Hemorrhage During Cesarean Section

Not yet recruiting Phase 3 Last updated 9 January 2025

What this trial tests

Phase 3 trial testing Misoprostol in Postpartum Hemorrhage in 400 participants. Not yet recruiting.

Timeline

1 January 2025

Primary endpoint
1 January 2026

1 March 2026

Quick facts

Lead sponsor	Assiut University
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	400
Start date	1 January 2025
Primary completion	1 January 2026
Estimated completion	1 March 2026

Drugs / interventions tested

• Misoprostol (Misoprostol) — full drug profile →

Conditions studied

• Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →

Sponsor

Assiut University

Who can join

18 and older, any sex, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.