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Uterotonics Using to Reduce Bleeding at Cesarean Section

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ClinicalTrials.gov Identifier: NCT02562300
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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.


Condition or disease Intervention/treatment Phase
Postpartum Haemorrhage Drug: Misoprostol Drug: Oxytocin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Study of Sublingual Misoprostol Versus Oxytocin in Reducing Bleeding at Cesarean Section
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sublingual misoprostol
The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate.
Drug: Misoprostol
400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Blood loss in ML [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Hematocrit value (%) [ Time Frame: 1 year ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02562300    
Other Study ID Numbers: Utrotonics during CS
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: January 2014
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents