Back to resultsEffect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Uterine Massage
Uterine Compression
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Uterine, Massage, Compression
Eligibility Criteria
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.
Sites / Locations
- American University of Beirut Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Massage
Compression
Arm Description
Women allocated to the uterine massage group will be provided with 2 minutes of trans-abdominal uterine massage starting promptly after placental delivery.
Women allocated to the uterine compression group will be provided with 2 minutes of sustained trans-abdominal uterine compression starting promptly after placental delivery.
Outcomes
Primary Outcome Measures
Incidence of blood loss of 500 mL or more
Collection of lost blood will be initiated immediately after delivery of the neonate by putting a drape under the woman's buttocks. Blood collected will be weighed on an electronic scale together with the drape, and the amount will be recorded in grams after subtracting the weight of the drape. The amount of blood loss will be recorded 30 mins after delivery of the neonate. The amount of lost blood in grams will be converted to volume by dividing by 1.06 (blood density in g/mL) for the analysis.
Secondary Outcome Measures
Maternal pain
Maternal discomfort and pain intensity will be evaluated after the intervention using a visual analogue scale (VAS), which consists of a two-sided rule with a 10 cm vertical or horizontal line linking two points, at one extreme indicating a total absence of pain and at the other the worst pain imaginable. The women will be required to mark a spot on the line corresponding to the intensity of their pain at that particular time on a possible scale of 0 to 10.
Change in hemoglobin as a measure of blood loss
The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.
Use of therapeutic uterotonics
the need to use uterotonic agent for PPH such a misoprostol or ergotamines
Use of balloon or surgical procedures for postpartum hemorrhage
needingto insert tamponading devices such as balloon
Need for blood transfusion and hospital stay
needing to transfuse the patient due to severe anemia
Full Information
NCT ID
NCT02396771
First Posted
March 19, 2015
Last Updated
July 20, 2021
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02396771
Brief Title
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
Official Title
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss and Maternal Pain After Vaginal Delivery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.
Detailed Description
Women allocated to either the massage or compression group will be given 10 units of oxytocin intramuscularly immediately after delivery of the shoulder and controlled cord traction will be performed to assist placental delivery. The umbilical cord will be clamped and cut approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and blood clots expelled as quickly as possible after delivery of the placenta.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Uterine, Massage, Compression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage
Arm Type
Experimental
Arm Description
Women allocated to the uterine massage group will be provided with 2 minutes of trans-abdominal uterine massage starting promptly after placental delivery.
Arm Title
Compression
Arm Type
Experimental
Arm Description
Women allocated to the uterine compression group will be provided with 2 minutes of sustained trans-abdominal uterine compression starting promptly after placental delivery.
Intervention Type
Procedure
Intervention Name(s)
Uterine Massage
Intervention Description
The massage will be performed as follows: palpating the uterine fundus, manually stimulating the fundus and the whole body of the uterus using fingers and palms steadily and repetitively.
Intervention Type
Procedure
Intervention Name(s)
Uterine Compression
Intervention Description
The sustained uterine compression will be performed as follows: placing one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall.
Primary Outcome Measure Information:
Title
Incidence of blood loss of 500 mL or more
Description
Collection of lost blood will be initiated immediately after delivery of the neonate by putting a drape under the woman's buttocks. Blood collected will be weighed on an electronic scale together with the drape, and the amount will be recorded in grams after subtracting the weight of the drape. The amount of blood loss will be recorded 30 mins after delivery of the neonate. The amount of lost blood in grams will be converted to volume by dividing by 1.06 (blood density in g/mL) for the analysis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Maternal pain
Description
Maternal discomfort and pain intensity will be evaluated after the intervention using a visual analogue scale (VAS), which consists of a two-sided rule with a 10 cm vertical or horizontal line linking two points, at one extreme indicating a total absence of pain and at the other the worst pain imaginable. The women will be required to mark a spot on the line corresponding to the intensity of their pain at that particular time on a possible scale of 0 to 10.
Time Frame
2 years
Title
Change in hemoglobin as a measure of blood loss
Description
The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.
Time Frame
2 years
Title
Use of therapeutic uterotonics
Description
the need to use uterotonic agent for PPH such a misoprostol or ergotamines
Time Frame
2 years
Title
Use of balloon or surgical procedures for postpartum hemorrhage
Description
needingto insert tamponading devices such as balloon
Time Frame
2 years
Title
Need for blood transfusion and hospital stay
Description
needing to transfuse the patient due to severe anemia
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Labib M Ghulmiyyah, MD
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery
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