Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Partum Haemorrhage |
Drug: Misoprostol Drug: Oxytocin Drug: Oxytocin and Misoprostol |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
- changes in hemoglobin levels after delivery [ Time Frame: Hemoglobin values will be determined both before surgery and 24 h following surgery ] [ Designated as safety issue: Yes ]
- Hemodynamic variables [ Time Frame: every 5 minutes during surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | February 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Misoprostol |
Drug: Misoprostol
The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it)
|
| Active Comparator: Oxytocin |
Drug: Oxytocin
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
|
| Active Comparator: Oxytocin and Misoprostol |
Drug: Oxytocin and Misoprostol
The combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate .
|
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pregnant women at term (37—40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | marzieh beigom khezri, assistant professor, Qazvin University Of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01571323 History of Changes |
| Other Study ID Numbers: | ACTRN12612000095864 |
| Study First Received: | April 3, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Qazvin University Of Medical Sciences:
|
post partum haemorrhage at cesarean section |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders Uterine Hemorrhage Oxytocin Misoprostol |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013