Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section

NCT01571323 | Completed Phase 1 DMC

• 1 other identifier: ACTRN12612000095864
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate that the combined used of low dose of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 50 each. The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate . The main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle. Hemoglobin values were determined both before surgery and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during surgery .The need for additional oxytocic therapy, operating time, infusion volume given intraoperatively, need for blood transfusion, side effects of study drug and any significant puerperal morbidity were also recorded.

Conditions

Post Partum Haemorrhage

Keywords

post partum haemorrhage at cesarean section

Outcome Measures

Primary Outcomes (1)

• changes in hemoglobin levels after delivery

  Hemoglobin values will be determined both before surgery and 24 h following surgery

Secondary Outcomes (1)

• Hemodynamic variables

  every 5 minutes during surgery

Study Arms (3)

Misoprostol

ACTIVE COMPARATOR

Drug: Misoprostol

Oxytocin

ACTIVE COMPARATOR

Drug: Oxytocin

Oxytocin and Misoprostol

ACTIVE COMPARATOR

Drug: Oxytocin and Misoprostol

Interventions

Misoprostol DRUG

The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it)

Misoprostol

Oxytocin DRUG

The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate

Oxytocin

Oxytocin and Misoprostol DRUG

The combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate .

Oxytocin and Misoprostol

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

You may not qualify if:

• women with any risk factor
• associated with an increased risk of postpartum
• hemorrhage were excluded i.e. anemia (Hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus.
• current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin Medical University Science

Qazvin, Qazvin Province, 3419759811, Iran

Location

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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

IR (1)