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

NCT05928871 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-23

No results posted yet for this study

Summary

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.

Conditions

  • Misoprostol Allergy

Interventions

DRUG

Misoprostol 200mcg Tab

60 women: will receive preoperative 600 microgram of misoprostol ( 3 tablets ) rectally after spinal anaesthesia and urinary catheterization and postoperative placebo (3 tablets). (as per WHO dose recommendation)

DRUG

Misoprostol Pill

60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohammed A Taymour, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-12-01
Completion
2023-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928871 on ClinicalTrials.gov