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Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866241
First Posted: May 31, 2013
Last Update Posted: September 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Makerere University
University Ghent
Information provided by (Responsible Party):
Mbarara University of Science and Technology
  Purpose
Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse [than 10 IU oxytocin] in management of third stage of labor

Condition Intervention Phase
Post Partum Hemorrhage Drug: Misoprostol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

Resource links provided by NLM:


Further study details as provided by Mbarara University of Science and Technology:

Primary Outcome Measures:
  • Estimated Blood loss [ Time Frame: 24 hours ]
    Estimated blood loss of more than or equal to 500ml


Secondary Outcome Measures:
  • Blood loss of more than 1000ml [ Time Frame: 24 hours ]
    Other secondary outcomes are: Hematocrit drop, additional uteretonic use

  • 1) maternal death, 2) pre and post delivery hemoglobin changes 3) pre and post delivery hematocrit changes 4) >10% hemoglobin drop 5) mean postpartum hemoglobin and hematocrit, 6) mean measured blood loss [ Time Frame: 24 hours ]
  • 7) placental retention 8) requirement for blood transfusion 9) requirement for additional therapeutic procedures or uterotonics 10) duration of the third stage of labor [ Time Frame: 24 hours ]

Other Outcome Measures:
  • Uteretonic use [ Time Frame: 24 hours ]

Enrollment: 1140
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: sublingual misoprostol 600µg
Misoprostol is a uteretonic drug
Drug: Misoprostol
Is a prostaglandin
Other Name: Prostaglandin, Cytotec
Placebo Comparator: Arm B: 10 IU Oxytocin
Oytocin is a standard of care treatment for PPH

Detailed Description:
Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Term mothers [38-41 WOA] above 18 years of age admitted at Mbarara Hospital, Uganda in active labor; anticipating vaginal delivery -

Exclusion Criteria:

Complicated labor:

  1. confirmed intra-uterine fetal death
  2. self-reported maternal heart disease
  3. current diagnosis of severe malaria or acute bacterial infection,
  4. multiple pregnancy,
  5. induced or augmented labor,
  6. elective Caesarean section,
  7. ante-partum hemorrhage,
  8. reported hypersensitivity to prostaglandins
  9. altered cognitive status (ACS) as assessed by the MRAs. -
  Contacts and Locations
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): NCT01866241


Locations
Uganda
Mbarara Regional Referral Hospital
Mbarara, Uganda, 1410
Sponsors and Collaborators
Mbarara University of Science and Technology
Makerere University
University Ghent
Investigators
Study Chair: Amon Agaba, PhD Mbarara University of Science and Technology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT01866241     History of Changes
Other Study ID Numbers: MUST-17-2012
First Submitted: May 28, 2013
First Posted: May 31, 2013
Last Update Posted: September 8, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Maternal Death
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Parental Death
Death
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics