NCT05928871

Pre Versus Post-operative Misoprostol in Reducing Blood Loss After Cesarean Section

Status unknown Phase 4 Last updated 23 August 2023

What this trial tests

Phase 4 trial testing Misoprostol 200mcg Tab in Misoprostol Allergy in 120 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
1 December 2023

30 December 2023

Quick facts

Lead sponsor	Cairo University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	120
Start date	1 June 2023
Primary completion	1 December 2023
Estimated completion	30 December 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Misoprostol 200mcg Tab — full drug profile →
• Misoprostol Pill — full drug profile →

Conditions studied

• Misoprostol Allergy — all drugs for Misoprostol Allergy →

Sponsor

Cairo University

Who can join

Adults 20 to 40, female only, with Misoprostol Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cesarean section is the most common performed major surgical interventions among women all over the world.Cesarean section has many serious complications, including primary postpartum hemorrhage (PPH). Postpartum hemorrhage is one of the most serious causes of maternal mortality and morbidity, especially in developing countries, and the number of maternal deaths due to postpartum hemorrhage is estimated to exceed 100,000 maternal deaths each year. The incidence of CS is increasing and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL) .

The most successful technique for decreasing PPH is active management of the third stage of labor (AMTSL), requires prophylactic utero-tonic drugs as oxytocin, ergometrine malate and combinations of them , They must be administered by injection.

Misoprostol is synthetic prostaglandin (PGE1 analogue), with utero-tonic properties, has been proposed as an alternative strategy for prevention of PPH in settings where oxytocin use is not handy. It has important advantages over oxytocin, including the potential for oral administration and a long shelf life at room temperature.Misoprostol is affordable and widely available, can be easily administered via multiple routes, and has a good safety profile if properly administered and monitored, all of which makes it an alternative treatment option of PPH in developing countries.

Investigators were comparing the effect of preoperative and post-operative rectally administrated misoprostol on operative blood loss at cesarean section. Misoprostol has an important effect in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.