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Uterine Massage After Vaginal Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858569
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Procedure: active management of third stage of labor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oxytocin
10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus
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.

Active Comparator: Oxytocin plus uterine massage
10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.
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.




Primary Outcome Measures :
  1. Postpartum hemorrhage [ Time Frame: during procedure ]
    The amount of blood loss after delivery of the fetus


Secondary Outcome Measures :
  1. Duration of third stage of the labor [ Time Frame: during procedure ]
    Delivery of the fetus and delivery of the placenta interval



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 years old women delivering vaginally

Exclusion Criteria:

  • women with bleeding disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858569


Contacts
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Contact: Berna Aslan Çetin 4141500 bernaaslan14@hotmail.com

Locations
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Turkey
Kanuni SSTRH Recruiting
Istanbul, Turkey, 34150
Contact: Alev Aydın    4141500    alevatis@gmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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Responsible Party: Berna Aslan Cetin, Md, ObGYN, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03858569    
Other Study ID Numbers: 2018/11/42
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage