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OpenTrials
Completed

NCT Number: NCT01866241

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

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

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mbarara Regional Referral Hospital

Mbarara, 1410, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • confirmed intra-uterine fetal death
  • self-reported maternal heart disease
  • current diagnosis of severe malaria or acute bacterial infection,
  • multiple pregnancy,
  • induced or augmented labor,
  • elective Caesarean section,
  • ante-partum hemorrhage,
  • reported hypersensitivity to prostaglandins
  • altered cognitive status (ACS) as assessed by the MRAs. -

Treatment and study plan

Misoprostol

Drug

Is a prostaglandin

Other names: Prostaglandin, Cytotec

Primary outcomes

  1. Estimated Blood loss

    Time frame: 24 hours

    Estimated blood loss of more than or equal to 500ml

Secondary outcomes

  1. Blood loss of more than 1000ml

    Time frame: 24 hours

    Other secondary outcomes are: Hematocrit drop, additional uteretonic use

  2. 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

  3. 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 outcomes

  1. Uteretonic use

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Collaborators

  • Makerere University
  • University Ghent

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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