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Management of the Third Stage of Labor

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxytocin
Oxytocin in 100 ml NaCl 0.9%
Sponsored by
Yariv yogev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Singleton pregnancy.
  • 34-41 weeks of gestation.
  • Maternal age between 18 and 45.

Exclusion Criteria:

  • Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm)
  • Coagulation defects
  • VAS score>3 (pain score)
  • Women with early PPH
  • Suspected placental abruption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Intramuscular treatment:IV

    Combined treatment:IV+IM

    The control group

    Arm Description

    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.

    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.

    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).

    Outcomes

    Primary Outcome Measures

    Change in Hemoglobin concentration during labor

    Secondary Outcome Measures

    Blood count (CBC) on the first and second day after delivery

    Full Information

    First Posted
    December 14, 2014
    Last Updated
    September 7, 2015
    Sponsor
    Yariv yogev
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02319707
    Brief Title
    Management of the Third Stage of Labor
    Official Title
    Management of the Third Stage of Labor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    January 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yariv yogev

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the efficacy of three different protocols of third stage management in preventing PPH.
    Detailed Description
    The third stage of labor refers to the period following the completed delivery of the newborn until the completed delivery of the placenta. The length of the third stage and its complications are affected by the uterine contractility and the duration of placental separation. The normal duration of third stage in nulliparous as well as in multiparous women is less than 30 minutes. There is strong evidence supporting the routine administration of uterotonic agents for the prevention of post-partum hemorrhage (PPH), in order to enhance natural uterine contraction in the third stage of labor, thus reducing the occurrence of PPH by 40%. There is a joint policy statement between the International Confederation of Midwives (ICM), the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO), all of which recommend active management of the third stage of labor in order to prevent PPH. active management led to a reduction in PPH incidence, maternal Hemoglobin<9g/dL and need for blood transfusion. (4-7). Active management of the third stage of labor involves prophylactic uterotonic treatment, early cord clamping and controlled cord traction to deliver the placenta. (2) Oxytocin is the first agent of choice for PPH prophylaxis because of its high efficacy and a low incidence of associated side effects. (6-9). Cotter et al found that the use of Oxytocin for PPH prophylaxis in the third stage of labor decreased the rate of maternal blood loss greater than 500 ml by approximately 50%. (10). Oxytocin route of administration is either intravenously (IV) or intramuscularly (IM), with no significant difference in PPH incidence (9). This is based on a pharmacokinetic research from 1972 which found no difference between the absorption rates in both routes of administration. Since then no further research targeting this question was preformed. (11-12). recent guidelines from WHO, FIGO and ICM all recommended the use of 10 IU Oxytocin IM. (4, 7,13). Previous studies have investigated the effect of intra-umbilical vein Oxytocin injection in reducing blood loss during the third stage of labor. This route of administration directs treatment to the placental bed and uterine wall, resulting in earlier uterine contraction and placental separation. However, limited published literature is available evaluating the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. A prospective, randomized controlled trial of 412 women found that intra-umbilical injection of oxytocin alongside active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage (14). Other uterotonic agents including Syntometrine (IM), Ergometrine (IM or IV) and Misoprostol (IM), can be used in active management of the third stage of labor. However, high quality evidence regarding their efficacy compared to Oxytocin is scarce. (9-10)

    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
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intramuscular treatment:IV
    Arm Type
    Experimental
    Arm Description
    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.
    Arm Title
    Combined treatment:IV+IM
    Arm Type
    Experimental
    Arm Description
    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.
    Arm Title
    The control group
    Arm Type
    Active Comparator
    Arm Description
    pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Other Intervention Name(s)
    Pitocin
    Intervention Description
    The study group: divided into two groups: • Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. • Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin in 100 ml NaCl 0.9%
    Intervention Description
    The control group: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).
    Primary Outcome Measure Information:
    Title
    Change in Hemoglobin concentration during labor
    Time Frame
    first and second day after delivery
    Secondary Outcome Measure Information:
    Title
    Blood count (CBC) on the first and second day after delivery
    Time Frame
    first and second day after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Singleton pregnancy. 34-41 weeks of gestation. Maternal age between 18 and 45. Exclusion Criteria: Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm) Coagulation defects VAS score>3 (pain score) Women with early PPH Suspected placental abruption
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yariv Yogev, professor
    Phone
    9723-9377490
    Email
    yarivy@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yariv Yogev, professor
    Organizational Affiliation
    Director, Division of obstetrics and delivery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33169839
    Citation
    Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
    Results Reference
    derived

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    Management of the Third Stage of Labor

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