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Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section

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ClinicalTrials.gov Identifier: NCT00107874
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries.

With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section.

We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: misoprostol Phase 2

Detailed Description:

Postpartum hemorrhage (PPH) is still among the leading causes of maternal morbidity and mortality. The incidence of PPH is reduced by active management of the third stage of labor which includes the use of uterotonics for pharmacological prophylaxis. However, there is an on-going debate about the optimal drug selection since uterotonics such as oxytocin and methylergometrine are liable for specific side effects and complications when administered within a dose range needed to be effective for PPH. In the search for an alternative to these conventional standard uterotonics, misoprostol (prostaglandin E1) has turned out to be an effective therapeutic option and has been implemented in actual treatment regimens. The objective of this study was to compare the effectiveness of oral applicated misoprostol versus intravenous oxytocin in reducing blood loss in low risk obstetric patients undergoing non-scheduled cesarean section (CS) under spinal anesthesia.

Comparison:

In this prospective, double blind study, parturients undergoing CS were randomized to receive either a) oral misoprostol and an infusion of normal saline supplemented with placebo, or b) an oral placebo and an infusion of normal saline, supplemented with oxytocin subsequently to intravenous oxytocin after cord clamping in both groups.

The primary outcomes were the amount of intra- and postoperative blood loss and the occurrence of drug-related side effects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Oral Misoprostol as a Second-line Alternative to Intravenous Oxytocin in Preventing Postoperative Blood Loss After Non-scheduled Cesarean Section: a Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : January 1999
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction of postpartum hemorrhage

Secondary Outcome Measures :
  1. Blood loss
  2. medicamentous side effects
  3. efficacy of medicaments

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation

Exclusion Criteria:

  • Emergency CS
  • Fetal distress
  • Fetal malformations
  • Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome)
  • Hypersensitivity to prostaglandins
  • Coagulopathy
  • Severe systemic disorders
  • An American Society of Anesthesiologists (ASA) physical status >/= 3
  • Severe asthma
  • Prior myomectomy
  • Maternal fever (> 38.5 °C)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107874


Locations
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Switzerland
Women's University Hospital, Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Irène Hösli, Prof. Dr. MD University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00107874    
Other Study ID Numbers: M73/99
First Posted: April 12, 2005    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Maternal
morbidity
mortality
 pregnancy
postpartum hemorrhage
Cesarean Section
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
 Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics