Uterine Massage After Vaginal Delivery
Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
1 other identifier
interventional
500
1 country
1
Brief Summary
The participants will be randomized into an oxytocin plus uterine massage group and an oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage group will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and placental delivery time will be recorded and compared between the groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2019
CompletedJanuary 9, 2024
January 1, 2024
8 months
February 27, 2019
January 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Postpartum hemorrhage
The amount of blood loss after delivery of the fetus
during procedure
Secondary Outcomes (1)
Duration of third stage of the labor
during procedure
Study Arms (2)
Oxytocin
ACTIVE COMPARATOR10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus
Oxytocin plus uterine massage
ACTIVE COMPARATOR10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.
Interventions
Active management of the third stage of the labor will be done administering oxytocin and cord traction.
Eligibility Criteria
You may qualify if:
- years old women delivering vaginally
You may not qualify if:
- women with bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni SSTRH
Istanbul, 34150, Turkey (Türkiye)
Related Publications (1)
Kadirogullari P, Aslan Cetin B, Goksu M, Cetin Arslan H, Seckin KD. The effect of uterine massage after vaginal delivery on the duration of placental delivery and amount of postpartum hemorrhage. Arch Gynecol Obstet. 2024 Jun;309(6):2689-2695. doi: 10.1007/s00404-023-07211-5. Epub 2023 Sep 12.
PMID: 37698604DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md, ObGYN, Principal Investigator
Study Record Dates
First Submitted
February 27, 2019
First Posted
February 28, 2019
Study Start
January 15, 2019
Primary Completion
September 15, 2019
Study Completion
September 15, 2019
Last Updated
January 9, 2024
Record last verified: 2024-01