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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
NCT02396771 |
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Date of registration:
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19/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
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Scientific title:
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Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss and Maternal Pain After Vaginal Delivery: a Randomized Controlled Trial |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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445 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02396771 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Labib M Ghulmiyyah, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AUBMC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women giving birth vaginally, aged between 20 and 40 years, with a singleton
pregnancy, gestational age of 36 or more weeks, and with fewer than or equal to three
previous childbirths.
Exclusion Criteria:
- Exclusion criteria include multiple gestation, fetal malpresentation, the third stage
of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis,
three or more previous induced abortions, preeclampsia, fetal death, polyhydramnios,
hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate
infusion, abruptio placentae and having an abdominal wall too thick to palpate the
fundus of the uterus or to perform uterine massage or compressions after delivery.
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Hemorrhage
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Intervention(s)
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Procedure: Uterine Massage
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Procedure: Uterine Compression
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Primary Outcome(s)
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Incidence of blood loss of 500 mL or more
[Time Frame: 2 years]
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Secondary Outcome(s)
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Use of balloon or surgical procedures for postpartum hemorrhage
[Time Frame: 2 years]
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Use of therapeutic uterotonics
[Time Frame: 2 years]
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Maternal pain
[Time Frame: 2 years]
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Need for blood transfusion and hospital stay
[Time Frame: 2 years]
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Change in hemoglobin as a measure of blood loss
[Time Frame: 2 years]
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Secondary ID(s)
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OGY.LG.02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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