Uterotonics Using to Reduce Bleeding at Cesarean Section

NCT02562300 | Completed Phase 2

• 1 other identifier: Utrotonics during CS
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Blood loss in ML

  1 year

Secondary Outcomes (1)

• Hematocrit value (%)

  1 year

Study Arms (2)

Sublingual misoprostol

ACTIVE COMPARATOR

The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.

Drug: Misoprostol

oxytocin

ACTIVE COMPARATOR

The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate.

Drug: Oxytocin

Interventions

Misoprostol DRUG

400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate.

Sublingual misoprostol

Oxytocin DRUG

20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h were given immediately after delivery of the neonate.

oxytocin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age 37-40 wk.
• Elective lower segment cesarean section.
• Under spinal anesthesia.

You may not qualify if:

• Anemia (Hb\> 8 g%).
• Multiple gestation.
• Antepartum hemorrhage.
• Poly-hydramnios.
• Two or more previous cesarean sections.
• History of previous rupture uterus.
• Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: September 29, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 12, 2020

Record last verified: 2020-08