Uterotonics Using to Reduce Bleeding at Cesarean Section

NCT ID: NCT02562300

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sublingual misoprostol

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

oxytocin

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: 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.

Interventions

Misoprostol

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

Intervention Type: DRUG

Oxytocin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Utrotonics during CS

Identifier Type: -

Identifier Source: org_study_id