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Uterine Massage After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
active management of third stage of labor
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-40 years old women delivering vaginally

Exclusion Criteria:

  • women with bleeding disorder

Sites / Locations

  • Kanuni SSTRHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oxytocin

Oxytocin plus uterine massage

Arm Description

10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus

10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.

Outcomes

Primary Outcome Measures

Postpartum hemorrhage
The amount of blood loss after delivery of the fetus

Secondary Outcome Measures

Duration of third stage of the labor
Delivery of the fetus and delivery of the placenta interval

Full Information

First Posted
February 27, 2019
Last Updated
August 16, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03858569
Brief Title
Uterine Massage After Vaginal Delivery
Official Title
Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
September 15, 2019 (Anticipated)
Study Completion Date
September 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus
Arm Title
Oxytocin plus uterine massage
Arm Type
Active Comparator
Arm Description
10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.
Intervention Type
Procedure
Intervention Name(s)
active management of third stage of labor
Intervention Description
Active management of the third stage of the labor will be done administering oxytocin and cord traction.
Primary Outcome Measure Information:
Title
Postpartum hemorrhage
Description
The amount of blood loss after delivery of the fetus
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Duration of third stage of the labor
Description
Delivery of the fetus and delivery of the placenta interval
Time Frame
during procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-40 years old women delivering vaginally Exclusion Criteria: women with bleeding disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berna Aslan Çetin
Phone
4141500
Email
bernaaslan14@hotmail.com
Facility Information:
Facility Name
Kanuni SSTRH
City
Istanbul
ZIP/Postal Code
34150
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alev Aydın
Phone
4141500
Email
alevatis@gmail.com

12. IPD Sharing Statement

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Uterine Massage After Vaginal Delivery

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