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Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India

2014-08-27 03:14:26 | BioPortfolio

Summary

This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Postpartum Hemorrhage

Intervention

Oxytocin in Uniject

Location

Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Belgaum
Karnataka
India

Status

Not yet recruiting

Source

Johns Hopkins Bloomberg School of Public Health

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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PubMed Articles [1237 Associated PubMed Articles listed on BioPortfolio]

Intramuscular oxytocin administration before vs. after placental delivery for the prevention of postpartum hemorrhage: A randomized controlled prospective trial.

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Patients Undergoing Cesarean Delivery After Exposure to Oxytocin During Labor Require Higher Postpartum Oxytocin Doses.

Experts recommend postpartum oxytocin to prevent uterine atony and hemorrhage, but oxytocin may be associated with dose-dependent adverse effects, and the correct dose of postpartum oxytocin has yet t...

The Effect of Intermittent Oxytocin Pretreatment on Oxytocin-Induced Contractility of Human Myometrium In Vitro.

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Heat-stable sublingual oxytocin tablets as a potential needle-free approach for preventing postpartum hemorrhage in low-resource settings.

Postpartum hemorrhage is a major cause of mortality and morbidity related to childbirth in developing countries. The recommended treatment includes administration of oxytocin; however, oxytocin is a h...

Prevention postpartum hemorrhage.

Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality.

Medical and Biotech [MESH] Definitions

Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum).

Drugs that stimulate contraction of the myometrium. They are used to induce LABOR, OBSTETRIC at term, to prevent or control postpartum or postabortion hemorrhage, and to assess fetal status in high risk pregnancies. They may also be used alone or with other drugs to induce abortions (ABORTIFACIENTS). Oxytocics used clinically include the neurohypophyseal hormone OXYTOCIN and certain prostaglandins and ergot alkaloids. (From AMA Drug Evaluations, 1994, p1157)

Cell surface proteins that bind oxytocin with high affinity and trigger intracellular changes which influence the behavior of cells. Oxytocin receptors in the uterus and the mammary glands mediate the hormone's stimulation of contraction and milk ejection. The presence of oxytocin and oxytocin receptors in neurons of the brain probably reflects an additional role as a neurotransmitter.

Transient autoimmune thyroiditis occurring in the POSTPARTUM PERIOD. It is characterized by the presence of high titers of AUTOANTIBODIES against THYROID PEROXIDASE and THYROGLOBULIN. Clinical signs include the triphasic thyroid hormone pattern: beginning with THYROTOXICOSIS, followed with HYPOTHYROIDISM, then return to euthyroid state by 1 year postpartum.

Abnormal placentation in which all or parts of the PLACENTA are attached directly to the MYOMETRIUM due to a complete or partial absence of DECIDUA. It is associated with POSTPARTUM HEMORRHAGE because of the failure of placental separation.

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