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NCT03858569 Clinical Trial

Uterine Massage After Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

Official title:
Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03858569
Other study ID # 2018/11/42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date September 15, 2019

Study information
Verified date January 2024
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage group will be will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus and will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. Collection of blood loss will be initiated immediately after delivery of the fetus by putting a drape under the woman's buttocks. Collected blood will be weighed and the amount will be recorded in grams.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date September 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18-40 years old women delivering vaginally Exclusion Criteria: - women with bleeding disorder

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• active management of third stage of labor
Active management of the third stage of the labor will be done administering oxytocin and cord traction.

Locations
Country Name City State
Turkey Kanuni SSTRH Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postpartum hemorrhage The amount of blood loss after delivery of the fetus during procedure
Secondary Duration of third stage of the labor Delivery of the fetus and delivery of the placenta interval during procedure
See also
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Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
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Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
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