Uterotonics Using to Reduce Bleeding at Cesarean Section

Status Completed

Clinical Trial Summary

Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.

A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage.

Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births.

Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects.

Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.

Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable.

Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration.

A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration.

However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02562300
Study type	Interventional
Source	Assiut University
Contact
Status	Completed
Phase	Phase 2
Start date	January 2014
Completion date	April 2015

View Details

See also
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Completed	`NCT01485562` - Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births	N/A
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Not yet recruiting	`NCT02396303` - Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage	Phase 0
Completed	`NCT01931410` - The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial	Phase 4
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Completed	`NCT01044082` - Prevention of Post-partum Haemorrhage	N/A
Completed	`NCT01116050` - Intrarectal Misoprostol in Postpartum Haemorrhage	Phase 3
Completed	`NCT02149472` - Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
Recruiting	`NCT02492087` - Topical Tranexamic Acid in Caesarean Section	Phase 3
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.