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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02562300
Other study ID # Utrotonics during CS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2014
Est. completion date April 2015

Study information

Verified date August 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss in ML 1 year
Secondary Hematocrit value (%) 1 year
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